Archive for September, 2020

Testosterone boosters include medications and supplements designed to increase testosterone levels in the body. While low testosterone can trigger a range of symptoms, increasing this hormone comes with risks.

In this article, we discuss different types of testosterone boosters and their effectiveness.

Testosterone is an androgen hormone that promotes the development of characteristics people typically associate with masculinity, such as facial hair, deep voice, and muscle growth.

Although testosterone is the principal male sex hormone, it is also present in females, though at much lower levels.

Testosterone influences various aspects of the human body, including:

The normal testosterone value in people varies due to many factors, such as age. The American Urological Association defines low testosterone as less than 300 nanograms per deciliter (ng/dL).

A 2017 study suggests the normal total testosterone range for males aged 1939 years is 264916 ng/dL. The research considers values higher than this as abnormally high.

Low testosterone, or hypogonadism, can occur due to an underlying medical condition, taking certain medications, or injuries to the testes. People may also experience high testosterone levels, typically due to anabolic steroid use, tumors on the adrenal glands, or a medical condition.

A testosterone booster, or testosterone supplement, refers to any natural or artificially produced substance that raises testosterone levels. These may include:

TRT, or androgen replacement therapy, is a medical treatment for low testosterone. It works by replacing the testosterone that the body is not producing. TRT may include:

Injectable testosterone, such as testosterone cypionate (Depo-Testosterone) and testosterone undecanoate (Aveed), contain testosterone esters suspended in oil. Esters are a type of biological compound.

A person can administer this form of testosterone by injecting the solution into the buttocks. People can take these injections every 24 weeks, depending on recommendations from doctors.

Transdermal testosterone includes medicated patches (Androderm) and gels (AndroGel) that people apply directly to the skin.

Androderm patches come in four different strengths: 2 mg, 2.5 mg, 4 mg, or 5 mg of testosterone. The recommended starting dose is one 4 mg patch every 24 hours. A person should apply this to clean, dry skin on the back, thighs, abdomen, or upper arms.

Testosterone gel is available at 1% and 1.62% concentrations. When starting the 1% formulation, a person should apply 50 mg once a day in the morning. The dosage can vary depending on their hormone levels.

Jatenzo is an oral testosterone capsule recently approved by the Food and Drug Administration (FDA) for treating hypogonadism due to underlying medical conditions. The FDA does not recommend Jatenzo for treating age-related low testosterone due to an increased risk of cardiovascular events.

Jatenzo is available in three strengths: 158 mg, 198 mg, and 237 mg. The manufacturers recommend that people start by taking 237 mg twice daily for 1 week. In clinical trials, 87% of participants achieved testosterone levels in the normal range at the end of treatment.

After the first week, a doctor can adjust the dosage according to a persons serum testosterone levels. People should also note that due to a potential increase in blood pressure, Jatenzo may increase the risk of cardiovascular events.

Some supplements may help increase the level of testosterone a persons body produces. These may include:

D-aspartic acid (DAA) is an amino acid that plays a role in creating and releasing several different hormones, including testosterone.

DAA acts on the hypothalamus, triggering an increase of gonadotropin-releasing hormone (GnRH). When GnRH is present, the pituitary gland releases luteinizing hormone (LH), which promotes testosterone production.

Dehydroepiandrosterone (DHEA) is a steroid hormone produced by the adrenal glands. It is a precursor hormone with minimal effects until the body converts it into other hormones, such as estrogen or testosterone.

Due to its effects, DHEA is a popular ingredient in testosterone-boosting supplements.

There are several reasons why a person might use testosterone boosters. These include:

Multiple factors can influence testosterone levels. The body naturally produces less of the hormone with age. In one 2016 study, researchers evaluated the levels of testosterone and DHEA of 271 healthy males between the ages of 4070.

The researchers found testosterone levels decreased by 1.28%, and DHEA decreased by 3.52% each year.

The following factors can lead to low testosterone levels:

TRT is effective in treating low testosterone, but it does not always address the underlying cause. A doctor may recommend lifestyle changes and other medication to treat hypogonadism due to overweight, metabolic disorders, or thyroid problems.

In a 2018 study, researchers coordinated seven controlled trials in 788 older males with low testosterone levels. The participants received either AndroGel 1% or a placebo for 12 months.

The results suggest that testosterone treatment led to moderate improvements in sexual function, bone density, and red blood cell count. Those in the testosterone treatment group showed mild improvements in walking distance, mood, and depressive symptoms.

In a 2017 article, researchers evaluated the efficacy of d-aspartic acid (DAA) reported in 27 animal and human studies.

Findings from the animal studies suggest that DAA increases testosterone levels. However, the human trials produced mixed results. This may be due to limitations of the study design, as well as differences in age, physical fitness levels, and the participants base testosterone levels.

A 2015 study researching the effects of DAA supplementation in 24 males with at least two years of resistance training suggests this technique either showed no significant changes or reduced testosterone levels based on the dosage.

The authors of a 2013 review examined findings from 25 randomized controlled trials that looked at the effects of DHEA supplementation in 1,353 men. The authors conclude it led to minor reductions in body fat, but no improvements in testosterone.

A 2018 review also states there is limited evidence to suggest that DHEA supplementation increases testosterone levels.

Testosterone boosters may provide the following benefits to people with low testosterone levels:

While testosterone replacement may help alleviate the symptoms of hypogonadism, it may not produce the same effects in people with naturally declining testosterone levels.

TRT may lead to the following side effects:

People who inject testosterone may experience pain, swelling, or bruising near the injection site. Topical testosterone gels and patches can also induce allergic reactions at the application site.

The American Urological Association only recommend TRT if a persons testosterone level is below 300 ng/dL, and they show symptoms of hypogonadism. However, the risks of TRT may outweigh its potential benefits.

The FDA does not regulate testosterone supplements, meaning that supplements vary widely in quality, purity, and dosage.

According to the FDA, there is a link between some bodybuilding supplements, as well as products marketed as testosterone alternatives, and the following adverse effects:

Testosterone boosters can help increase a persons testosterone levels. However, their effectiveness will vary based on the type of booster and a persons reasons for taking them.

Testosterone therapy appears to benefit people with conditions such as hypogonadism. However, TRT is usually not recommended to treat age-related declines in testosterone unless managing sexual dysfunction.

More research is necessary to support the use of alternative therapies, such as testosterone supplements. Supplements may also carry some risk of cardiovascular, kidney, and liver disease.

People should always consult a doctor before they start a new medication or supplement.

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Testosterone boosters: Uses and effectiveness - Medical News Today

The 46-year-old remains in hospital with multiple injuries, including stab wounds to his neck, head and chest, fractures to his left shoulder, ribs and left arm, and a shattered shin.

He said his injuries are so severe he is in excruciating pain and will be in a wheelchair for at least the next 18 months.

"I just want to thank my neighbours who heard me shouting and ran to my aid, he said.

"If they hadnt responded to my calls, with the amount of pain I was in and the fact I absolutely couldnt move, I was that broken, I dont think I would be here today.

"I thought it was a nightmare until I felt the searing pain. Theyd left me for dead.

"My shins broken in four pieces and is being held together by pins, and Im still in terrible pain.

"But the thing Im most gutted about is that I wont be able to return to my home and the most incredible community in Meersbrook, where Ive enjoyed living so much for the last 11 years.

Mr Sinclair said that even if he felt safe returning to his house he wouldnt be able to return because his injuries are so bad the terraced property would no longer be suitable.

The former welder already had a number of disabilities, including fibromyalgia, which causes pain and tiredness, spinal injuries from a crash 10 years ago, which left him unable to work, and a rare condition called hypopituitarism, which affects his body's ability to produce vital hormones.

He was first attacked at around 1am that before before the second more serious assault, involving three assailants, happened at around 4.30am.

No one has been arrested.

Anyone with information should call South Yorkshire Police on 101 or Crimestoppers, anonymously, on 0800 555 111.

Here is the original post:
Disabled Sheffield man reveals horrific injuries after being stabbed in his own home - The Star

ROCKLAND, Mass. and NEW YORK, Sept. 18, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study online ahead of print in The New England Journal of Medicine. These results were published simultaneously with additional analyses being presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and describe the efficacy of BAVENCIO(avelumab) as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma (UC) and highlight exploratory biomarkers as well as patient-reported outcomes. In June, the US Food and Drug Administration (FDA) approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy based on the JAVELIN Bladder 100 results.

In the JAVELIN Bladder 100 study, BAVENCIO plus best supportive care (BSC) significantly extended overall survival (OS) compared with BSC alone in the two primary populations of all randomized patients and patients whose tumors were PD-L1+, and significantly more patients who received BAVENCIO as first-line maintenance were alive at one year.1 The clinical benefits of BAVENCIO were seen across a range of patient populations.1,2

"These data, which supported the recent FDA approval and updates to NCCN and ESMO guidelines, establish that BAVENCIO first-line maintenance treatment could fundamentally change clinical practice for the treatment of patients with locally advanced or metastatic urothelial carcinoma," said Thomas Powles, MBBS, MRCP, MD, Professor of Genitourinary Oncology, Lead for Solid Tumour Research at Barts Cancer Institute, Queen Mary University of London, and Director of Barts Cancer Centre, London, UK. "It is notable that the longer overall survival with BAVENCIO maintenance therapy was observed across all pre-specified subgroups examined and that this prolonged overall survival was gained without a detrimental impact on patients' quality of life."

Primary AnalysisIn the JAVELIN Bladder 100 study, OS was significantly longer with BAVENCIO plus BSC compared to BSC alone in the primary population of all randomized patients (n=700) whose disease had not progressed on first-line platinum-containing chemotherapy:

In the other primary population of patients with PD-L1+ tumors (n=358):

All endpoints were measured from the time of randomization, after completion of four to six cycles of chemotherapy.

Subgroup AnalysisResults of an exploratory subgroup analysis show that consistent results were observed with the JAVELIN Bladder regimen of BAVENCIO first-line maintenance across pre-specified subgroups, including best response to first-line chemotherapy, type of chemotherapy regimen, site of baseline metastasis, and other baseline factors.1 In particular, hazard ratios for OS based on response to first-line chemotherapy were as follows:

With regard to first-line chemotherapy regimen, hazard ratios were as follows:

Further detail from the subgroup analysis were presented in an on-demand mini oral session at the meeting (Presentation #704MO). Additional data evaluating the association between clinical outcomes and exploratory biomarkers will be presented in the Proffered Paper 1 - GU, non prostate session on Saturday, September 19 (Presentation #699O), and patient-reported outcomes are featured in an on-demand e-poster display (Presentation #745P).

Safety No new safety signals were identified in the JAVELIN Bladder 100 study, and the safety profile was consistent with previous studies of BAVENCIO monotherapy.1 Treatment-related adverse events of grade 3 or higher occurred in 57 patients (16.6%) treated with BAVENCIO plus BSC; no grade 3 or higher treatment-related events occurred in the control arm.1 No grade 4 or fatal immune-related adverse events occurred.1 Investigators attributed two patient deaths in the BAVENCIO plus BSC arm (0.6%), due to sepsis and ischemic stroke, to study treatment toxicity.1

About JAVELIN Bladder 100JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC. The primary endpoint was OS in the two primary populations of all patients and patients with PD-L1+ tumors defined by the Ventana SP263 assay. Secondary endpoints included progression-free survival, anti-tumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes in the co-primary populations. All primary and secondary endpoints are measured from the time of randomization.

About Urothelial Carcinoma Bladder cancer is the tenth most common cancer worldwide.4 In 2018, there were over half a million new cases of bladder cancer diagnosed, with around 200,000 deaths from the disease globally.4 In the US, an estimated 80,470 cases of bladder cancer were diagnosed in 2019, with around 12,500 locally advanced or metastatic cases presented annually.5,6 UC, which accounts for about 90% of all bladder cancers,7 becomes harder to treat as it advances, spreading through the layers of the bladder wall.8 Only 25% to 55% of patients receive any second-line therapy after first-line chemotherapy.9-15 In the US and EU5 markets, approximately 40% to 50% of patients receive an immune checkpoint inhibitor in second-line therapy.3 For patients with advanced UC, the five-year survival rate is 5%.5

About BAVENCIO (avelumab)BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.16-18 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved IndicationsBAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved Label BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with fatal, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with fatal, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and control hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinibcan cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

A fatal adverse reaction (sepsis) occurred in one (0.3%) patient with locally advanced or metastatic urothelial carcinoma (UC) receiving BAVENCIO plus best supportive care (BSC) as first-line maintenance treatment. In patients with previously treated locally advanced or metastatic UC, fourteen patients (6%) who were treated with BAVENCIO experienced either pneumonitis, respiratory failure, sepsis/urosepsis, cerebrovascular accident, or gastrointestinal adverse events, which led to death.

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic UC receiving BAVENCIO plus BSC (vs BSC alone) as first-line maintenance treatment were fatigue (35% vs 13%), musculoskeletal pain (24% vs 15%), urinary tract infection (20% vs 11%), and rash (20% vs 2.3%). In patients with previously treated locally advanced or metastatic UC receiving BAVENCIO, the most common adverse reactions (all grades, 20%) were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.

Selected laboratory abnormalities (all grades, 20%) in patients with locally advanced or metastatic UC receiving BAVENCIO plus BSC (vs BSC alone) as first-line maintenance treatment were blood triglycerides increased (34% vs 28%), alkaline phosphate increased (30% vs 20%), blood sodium decreased (28% vs 20%), lipase increased (25% vs 16%), aspartate aminotransferase (AST) increased (24% vs 12%), blood potassium increased (24% vs 16%), alanine aminotransferase (ALT) increased (24% vs 12%), blood cholesterol increased (22% vs 16%), serum amylase increased (21% vs 12%), hemoglobin decreased (28% vs 18%), and white blood cell decreased (20% vs 10%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Informationand Medication Guideavailable at http://www.BAVENCIO.com.

About Merck KGaA, Darmstadt, Germany-Pfizer AllianceImmuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribeto register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany, in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Pfizer Inc.: Breakthroughs that change patients' livesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com.In addition, to learn more, please visit us on http://www.pfizer.comand follow us on Twitter at @Pfizerand @Pfizer_News, LinkedIn, YouTubeand like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice The information contained in this release is as of September 18, 2020. Pfizer assumes no obligation to update forward-looking statementscontained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), including an indication for first-line maintenance therapy for BAVENCIO for the treatment of patients with locally advanced or metastatic urothelial carcinoma, the alliance between Merck KGaA, Darmstadt, Germanyand Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and whenany drug applications may be filed in any other jurisdictions for BAVENCIO for first-line maintenance therapy for locally advanced or metastatic urothelial carcinoma in any jurisdictions or for any other potential indications for BAVENCIO or combination therapies in any jurisdictions; whether and when regulatory authorities in any jurisdictions where any applications are pending or may be submitted for BAVENCIO or combination therapies, including BAVENCIO for locally advanced or metastatic urothelial carcinoma may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy, and, if approved, whether they will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of BAVENCIO, including BAVENCIO for locally advanced or metastatic urothelial carcinoma; the impact of COVID-19 on our business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

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Original post:
BAVENCIO Pivotal Phase III JAVELIN Bladder 100 Results Published in The New England Journal of Medicine - PRNewswire

Image: Breast cancer cell. Credit:Anne Weston, Francis Crick Institute,CC BY-NC

Read more news presented at the 2020 European Society for Medical Oncology (ESMO) meeting:

A new treatment for breast cancer patients with hormone receptor (HR+) early stage disease who are at a high risk of recurrence has been shown to reduce the risk by 25 per cent in the first two years, according to a new study.

The results of the monarchE study presented at the European Society for Medical Oncology Virtual Congress (ESMO) and published simultaneously in the Journal of Clinical Oncology (JCO), have been described as one of the most promising breakthroughs for patients with this type of breast cancer in the last 20 years.

The global randomised Phase III study was led by The Royal Marsden NHS Foundation Trust.The Institute of Cancer Research, London, works in close partnership with The Royal Marsden to take research into the clinic.

The trial involved 5,637 patients in 38 countries and tested if patients taking the CDK 4/6 inhibitor abemaciclib along with hormone therapy following standard of care treatments (chemotherapy, surgery and/or radiotherapy) would reduce the risk of recurrence compared with the standard hormone treatment alone.

Approximately 70 per cent of breast cancer patients have hormone receptor positive tumours, and of those a proportion of patients will have a higher risk of relapsing in the first two of years.

Patients with disease that has spread to lymph nodes, a large tumour size at the time of diagnosis, or an increased cellular proliferation (determined by high grade of the tumour, or number of dividing cells) were considered to be at high risk of recurrence and recruited to the study.

The study found a 25 per cent reduction in recurrence of cancer within the first two years when abemaciclib was added to the standard hormone therapy compared with the hormone therapy alone. During this time 11.3 per cent of patients in the control group had a relapse of their cancer compared with 7.8 per cent of those in the abemaciclib group.

Professor Stephen Johnston, Consultant Medical Oncologist at The Royal Marsden and Professor of Breast Cancer Medicine at The Institute of Cancer Research, London, said:

The monarchE research has given us a confidence that we will soon be to offer our high risk HR+ patients a greater chance of keeping them cancer free. While there have been many advances in other early breast cancer subtypes such as HER2 positive disease, there has been no significant advancements for the large group of patients who have hormone receptor positive breast cancer since the late 1990s when aromatase inhibitors were introduced. This research could potentially save many lives in the future.

Patient Sarah Ryder, 57, participated in the trial. She said:

When I was referred to The Royal Marsden last year and Professor Johnston told me about the monarchE trial I was so pleased to be part of something that could potentially save my life. By that stage my cancer had spread to 23 lymph nodes and I honestly did not feel much hope.

The trial has helped me believe in a future again. I can see my daughter grow up, go off to university next year and maybe have a family of her own one day.

Breast cancer research at The Royal Marsden is funded by The Royal Marsden Cancer Charity and National Institute for Health Research. The monarchE trial was funded by Eli Lilly and Company.

Read the original here:
ESMO 2020: Research breakthrough offers new hope for high risk patients with HR+ breast cancer - The Institute of Cancer Research

Its important to remember that what we find important in medicine is not necessarily what our patients find important, Dr. Wilkinson said. Often, doctors focus only on the efficacy of a particular method, rather than how acceptable it is to a particular patient. When she talks to adolescents, I ask them, does it matter to you to have your period every month, she said, and whether your partner can see the method or is aware that youre on birth control.

For some adolescents, it may be important that they can stop the method whenever they want. And the conversation has to include a discussion of what would happen if a method were not to be used, or were to fail, and about the importance of being able to discuss all these issues with your partner.

Pediatricians need to be comfortable having these conversations, Dr. Wilkinson said. Data shows young people are transitioning into their sexual lives during the time we are taking care of them, she said. The dialogue should include conversations about when they are ready for that transition, and how that reflects their personal values.

Even in medicine, some may have assumed that contraception would not be a priority during a pandemic, she said, but that is not necessarily true. And the topic is even more important this fall, with a whole cohort of young people either going back to universities under extraordinary conditions, or else not going back to their universities, where they might be accustomed to getting health care.

Updated Sept. 22, 2020

The latest on how schools are reopening amid the pandemic.

As some college students do go back to campus, Dr. Lindberg said, colleges and universities response and guidance around safe behaviors around Covid ignored the fact that young people are sexual beings.

Instead, what we see are guidelines that say, no guests allowed in your room, she said. Kids are going to break that rule, and then were going to be mad at them. Guidance should emphasize careful decision making, she said, both with respect to sex and with respect to Covid, and guidelines should be cast in terms of risk reduction and consent. It cant be all or nothing, because that model fails, she said.

The themes repeat themselves again and again, Dr. Lindberg said. You need to have empowered them and given them the skills how they make decisions, how they choose their actions wisely. She pointed to the New York Department of Health guidelines for sexual behavior, which start with the advice that you are your own safest sexual partner, but move beyond that to address the specific risks of different kinds of behavior.

Read more here:
For Young Peoples Sexual Health, the Pandemic Changes the Game - The New York Times

Updated results from the phase 3 ALTERNATIVE study showed that dual HER2 blockade plus aromatase inhibition (AI) in post-menopausal women with HER2-positive, hormone receptor (HR)positive metastatic breast cancer outperformed single HER2 blockade.

The new results, printed in theJournal of Clinical Oncology,1 include numerical corrections that affected secondary analyses but did not affect the major conclusions of the study; nonetheless, the original ALTERNATIVE study, which was published in 2017, was retracted.

Typically, according to the investigators led by Stephen R. D. Johnston, PhD, of the Royal Marsden NHS Foundation Trust, in England, patients with HER2-positive cancers are given chemotherapy regardless of their HR status. Johnston and colleagues noted that targeted agents such as trastuzumab (Herceptin), lapatinib (Tykerb), pertuzumab (Perjeta), and trastuzumab-emtansine (T-DM1; Kadcyla) have significantly improved outcomes. However, the investigators said not all patients need or can tolerate chemotherapy. In such cases, anti-HER2 therapies paired with endocrine therapy can be a good option. Earlier research has suggested HER2-blockade with endocrine therapy (ET) in the first-line setting can improve outcomes over ET alone. In the ALTERNATIVE study, Johnston and colleagues set out to evaluate the use of a dual HER2-blockade, using a combination of trastuzumab and lapatinib.

Dual targeting of HER2-positive tumors with [trastuzumab] and [lapatinib] is benecial because of differing mechanisms of action and because of the well-characterized synergistic interaction between them in HER2 [breast cancer] models, the investigators wrote. In the clinic, dual anti-HER2 blockade has been shown to improve outcomes in both the neoadjuvant and the metastatic setting compared with single HER2 blockade.

The investigators enrolled a group of 355 patients with HER2-positive/HR-positive metastatic breast cancer who were not expected to undergo chemotherapy and who had previously received treatment with ET and had progressed on or after a trastuzumab and chemotherapybased neoadjuvant/adjuvant regimen and/or in the first-line setting. The enrollees were randomly split into 3 groups: one group received lapatinib plus trastuzumab plus AI (n = 120), one group received trastuzumab plus AI (n = 117), and the final group received lapatinib plus AI (n = 118). Investigators chose whether patients received steroidal or nonsteroidal AI.

The primary end point was to evaluate progression-free survival (PFS) with lapatinib plus trastuzumab and AI versus trastuzumab plus AI.

The data showed that lapatinib plus trastuzumab and AI had a median PFS of 11 months (HR, 0.62; 95% CI, 0.45-0.88; P = .0063) versus 5.6 months on the trastuzumab-plus-AI. Overall response rate (ORR), clinical benefit rate, and overall survival were also superior in the lapatinib plus trastuzumab and AI group.

Comparing lapatinib plus AI to trastuzumab plus AI resulted in a median PFS of 8.3 months versus 5.6 months, respectively (HR, 0.85; 95% CI, 0.62-1.17; P = .3159).

The rates of any-grade adverse events (AEs) were 92% with the triplet regimen, 74% with trastuzumab and AI, and 92% with lapatinib and AI. Most AEs were grade 1 or 2, and the most common were diarrhea, rash, nausea, and paronychia. Rates of serious AEs were similar across the 3 groups, though the group with lapatinib plus trastuzumab and AI had the lowest number of AEs leading to discontinuation.

Johnston and colleagues wrote that although it is too early to report survival data, early indications suggest the dual blockade is similarly superior.

The investigators noted that their results contrast with the lack of benefit shown in the adjuvant setting in the ALTTO2trial, and the minimal benefit shown in the APHINITY3 trial.

This discrepancy may be the result, at least in part, of the excellent outcome with adjuvant single HER2 blockade with [trastuzumab], making the demonstration of additional benefit with dual blockade challenging, they wrote. Dual HER2 blockade may benefit only a small subject of high-risk patients.

In conclusion, the authors said the results of this trial show a clinically meaningful and robust benefit with lapatinib plus trastuzumab and AI in patients previously treated with trastuzumab and ET, as well as a relatively good tolerability. Thus, they said, the data suggest patients with HER2-positive/HR-positive metastatic breast cancer who are not candidates for chemotherapy should be considered for this regimen.

This combination can potentially offer an effective and well-tolerated chemotherapy-sparing alternative treatment regimen for patients for whom chemotherapy is not intended, Johnston et al concluded.

References:

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Updated ALTERNATIVE Results Favor Dual HER2 Blockade in HER2+/HR+ Metastatic Breast Cancer - Targeted Oncology

Both abortion advocates and opponents have used the COVID-19 crisis to further their policy goals.

The gendered dimensions of the political response to the COVID-19 crisis are manifesting clearly in efforts to close abortion clinics, as well as in campaigns led by doctors, lawyers, and reproductive rights advocates to expand access to telemedicine abortion during the pandemic and beyond.

Anti-abortion politicians in states across the country have used the COVID-19 pandemic to attempt to restrict abortion, arguing that abortion is not essential health care and that banning the procedure will conserve personal protective equipment for COVID-19 cases. In March and April of 2020, 12 states tried to restrict abortion, including Alaska, Iowa, Louisiana, Mississippi, and West Virginia, among others. Legislators in Kentucky passed a bill to allow the states Attorney General to block abortion access during COVID-19, but the Kentucky governor vetoed the bill.

Advocates for abortion rights have condemned these actions and sued to keep clinics open. The National Abortion Federation, a professional association of abortion providers, issued a statement declaring that abortion care is an essential health service and that denying or deferring abortion care places an immediate burden on patients, their families, and the health system, and can have profound and lasting consequences. The Center for Reproductive Rights, the American Civil Liberties Union, and clinics in states with abortion bans have brought legal challenges to protect abortion access during the pandemic.

In response, courts have blocked the bans in Alabama, Ohio, Oklahoma, and Tennessee. In Louisiana, the state lifted the ban after clinics sued. Texas finally lifted its ban on April 22 after multiple court decisions see-sawed back and forth for weeks, forcing pregnant people to travel hundreds of miles to other states to obtain abortion care.

But restrictions prevailed in some states. The U.S. Court of Appeals for the Eighth Circuit upheld an abortion ban in Arkansas, although the Arkansas Department of Health later issued a directive permitting providers to resume elective procedures. Banssome of which were lifted or have since expiredhave not been challenged in Alaska, Indiana, and Mississippi, whereas a clinic in West Virginia challenged a ban in the state, which the Governor later lifted.

In addition to filing lawsuits challenging the bans, abortion advocates are calling for greater access to telemedicine abortion to provide safe, accessible, socially distant abortion health care.

Telemedicine abortion combines medication abortionwhich uses pills to end a pregnancyand telemedicinewhich allows providers to supervise the use of abortion pills through videoconferencing or telephone consultations. Approved by the U.S. Food and Drug Administration (FDA) for use during the first 10 weeks of pregnancy, medication abortion uses two types of pills: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy, and misoprostol, which causes contractions. Misoprostol alone, or in combination with mifepristone, is an extremely safe way to end a pregnancy in the first 12 weeks of gestation. According to the Guttmacher Institute, medication abortion accounted for approximately 40 percent of all recorded abortions and 60 percent of abortions performed up to 10 weeks gestation in 2017. The actual rate is likely higher because of the growing number of people who are self-managing their abortions using medication purchased on the internet or obtained in other ways.

The growth in the use of medication abortion has dovetailed with expansion of telehealth to provide new opportunities for pregnant people to access abortion in a safe and private way. As abortion restrictions have increased over the last several years and harassment of people entering health clinics persistseven during the COVID-19 crisispregnant people are increasingly turning to medication abortion and telehealth to increase their safety and privacy when obtaining abortion care. Reproductive health advocacy organizations, such as Aid Access, Plan C, and the Self-managed Abortion; Safe and Supported Project, provide pregnant people with information and support on how to use abortion pills safely, especially with the recent proliferation of abortion bans in conservative states.

Nevertheless, numerous legal and regulatory barriers limit the reach of telehealth abortion. Many states prohibit patient access to the abortion pill through telemedicine, despite the pills proven safety and efficacy. Eighteen states currently require the prescribing clinician to be physically present when prescribing the abortion pill. Thirty-two states require the clinician prescribing the abortion pill to be a physician.

Another significant barrier to telemedicine abortion is that FDA restricts the distribution of mifepristone. When FDA initially approved the drug in 2000, the agency blocked easy access to the pill using its Risk Evaluation and Mitigation Strategies (REMS) due to pressure from anti-abortion forces. REMS is a drug safety program that allows FDA to restrict the circulation of certain medications with serious safety concerns to help ensure that the benefits of the medication outweigh its risks. Under the REMS program, mifepristone must be dispensed in person at a clinic, medical office, or hospital under the supervision of a health care provider registered with the drug manufacturer.

In light of COVID-19 and the need for social distancing, advocates are challenging FDAs REMS restriction on the abortion pill. On March 30, California Attorney General Xavier Becerra sent a strongly-worded letter to the U.S. Department of Health and Human Services and FDA, urging the Trump Administration to waive or use its discretion on enforcement of its REMS designation.

Forcing women to unnecessarily seek in-person reproductive health care during this public health crisis is foolish and irresponsible, Attorney General Becerra stated at a press conference. That is why we are calling on the Trump Administration to remove red tape that makes it more difficult for women to access the medication abortion prescription drug.

On the same day, New York Attorney General Letitia James spoke out in favor of removing the FDA restriction on mifepristone. Control over ones reproductive freedom should not be limited to those able to leave their homes as we battle the coronavirus, Attorney General James said. She highlighted that a coalition of state attorneys general is calling on the federal government to make mifepristone more easily accessible so that no woman is forced to risk her health while exercising her constitutional right to an abortion.

Reproductive health groups are also pressuring the government to remove the REMS restriction on the abortion pill. The National Womens Health Network, for example, created a petition and social media campaign with the slogan, Get the pill where you take the pillat home!

In addition to lobbying FDA, medical providers and advocates are filing lawsuits to remove the REMS restriction on mifepristone. On May 27, the American College of Obstetricians and Gynecologists (ACOG) filed a lawsuit challenging the FDA restriction. Joined by the Council of University Chairs of Obstetrics and Gynecology, the New York Academy of Family Physicians, and SisterSong, ACOG is asking a federal district court to order FDA to lift the REMS restriction on mifepristone during the COVID-19 crisis.

In July, Judge Theodore Chuang of the U.S. District Court for the District of Maryland issued a decision temporarily suspending enforcement of FDAs restriction on the abortion pill, ruling the FDA requirement of in-person visits during the pandemic imposes a substantial obstacle to abortion health care that is likely unconstitutional. Judge Chuangs order allowed patients to receive mifepristone from their doctors through the mail. The Trump Administration asked the district court, and then the U.S. Court of Appeals for the Fourth Circuit, to reinstate the in-person requirements while FDA appeals the decision, but both courts rejected the Administrations request. The Administration has now taken its request to the U.S. Supreme Court.

Some reproductive health advocacy organizations have also promoted self-managed abortion, a process by which people order abortion pills online and use them independently of any direct medical supervision. Plan C maintains an updated list of safe websites from which to order abortion pills and also has information about how to self-manage abortion safely using the pills. Although self-managing abortion involves some legal risks, for many people it might be safer than traveling long distances to access abortion health care or risking further delay in securing an abortion.

Research shows that self-managed abortion has increased during the coronavirus, especially in conservative states that have enacted restrictions on abortion. The legal advocacy organization If/When/How has a new campaign and an online petition pushing for the decriminalization of self-managed abortion, which the organization argues is critical during the coronavirus epidemic. In a campaign fact sheet on self-managing abortion during the COVID-19 crisis, If/When/How argues that during times of heightened societal fear, overzealous police, prosecutors, and anti-abortion politicians may more than usualrely on a racist, classist criminal legal system to punish people for their pregnancy outcomes. The group also expresses concern that international postal delivery and transit across international borders could be slowed, interrupted, or suspended as countries around the world enact safety measures, affecting the distribution of abortion medication.

Another way to increase abortion access during the pandemic, as well as afterwards, is to expand a research exception to the REMS restriction. Since 2016, the womens reproductive health care organization Gynuity has operated a research study on telemedicine abortion, TelAbortion, which allows clinicians participating in the study to provide medication abortion care by videoconference and mail without an in-person visit. The study is currently running in Washington, D.C. and 13 states, including Hawaii, Washington, and Oregon, among others. This study has shown that telemedicine abortion is safe and effective. Advocates are working to expand the TelAbortion program to more states.

Both advocates for and opponents of abortion have used the COVID-19 crisis as an opportunity to advance their political agendas. Although anti-abortion politicians have tried to ban abortion as a non-essential medical procedure, womens health advocates have pressed for increased access to the abortion pill and telemedicine abortion.

These abortion policies have gendered impacts. Restrictions on abortion impose on female, transgender, and nonbinary people unwanted pregnancies and medical risks, especially during a pandemic, while removing these restrictions frees pregnant people from the burdens, costs, and risks of unwanted pregnancy and parenthood during dire economic times.

Carrie N. Bakeris a professor in the Program for the Study of Women and Gender at Smith College.

Go here to see the original:
Abortion Regulation in the Age of COVID-19 - The Regulatory Review

San Diego State University is reeling from a calamitous outbreak of COVID-19, with 882 students testing positive or probable. Is the same thing about to happen at UC San Diego?

The answer will begin to emerge this weekend as 7,500 undergraduates start to move into meticulously cleaned dorms on the sprawling La Jolla campus for the start of the fall quarter.

UCSD has been running drills that simulate mass infections, but even that may not have fully prepared the university for what it is about to face as it begins its 60th year.

College students nationwide have been shrugging off the pandemic, leading to tens of thousands of COVID-19 infections and billions of dollars in costs.

The trouble spots include SDSU, which is providing mostly online classes to about 35,000 students this fall, most of whom wont be on campus due to the pandemic.

But the university wanted to offer a semblance of normalcy to some of its youngest students. So it put 2,600 of them in dorms with the proviso that everyone wear masks and socially distance.

SDSU didnt pressure students to comply, or require that everyone get tested for COVID-19.

Many students ended up ignoring the rules. Over two weekends in August, the Union-Tribune watched hundreds of them roaming without masks, especially in the party-hearty section of the College Area neighborhood.

Signs provide warnings and information about COVID-19 on the campus of San Diego State University on Monday, Sept. 14, 2020. The university had to pause in-person instruction in an attempt to prevent the spread of the novel coronavirus.

(Sam Hodgson/The San Diego Union-Tribune)

At a bash on Pontiac Street, about 35 students had to squeeze past each other just to get around. Not far away, other mask-less students lingered outside the Paseo Place housing complex, two blocks from the student health center.

Within two weeks, the coronavirus was spreading rapidly. Dorm students were placed in quarantine. The small number of in-person classes were shifted online. The campus enlisted administrators to help patrol the streets for students shirking the rules. And SDSU last week finally began requiring on-campus dorm students to be tested for the coronavirus.

The university knew over the summer that students were having parties in the College Area, and that they could spread the virus, but they did not do enough to make sure things wouldnt get out of hand, said Scott Kelley, a microbiologist at SDSU who studies how aerosols spread indoor.

We can spend $8 million on a basketball coach, $30 million on Mission Valley, but we cant do things to make sure students wear masks and get tested. It doesnt make any sense. (Kelleys bio).

To date, at least 882 SDSU students have tested positive or probably for the coronavirus, a number that could contribute to another round of state-ordered restrictions on where people can go and what they can do in San Diego County.

SDSUs neighbors in the College Area are especially worried about being infected by students. County health officials say students have already spread the virus to at least seven people outside the SDSU community.

Less than 20 miles away, UCSD has been game planning what it should do when 38,000 students begin the fall quarter on Sept. 28 with a slate of mostly online classes.

About 11,000 undergraduate and graduate students will live in campus housing.

Jayden Pearson receives a coronavirus test before checking into her dorm at UCSD on Saturday.

(Sandy Huffaker)

The university will try to prevent an outbreak by conducting regular mandatory testing, monitoring waste water for the virus, and getting people to use a cellphone app that tells them if theyve had contact with infected people.

UCSD also will have student ambassadors moving about, helping coax students into wearing masks and staying 6 feet apart.

As much as anything, defeating COVID-19 on campus involves getting rambunctious, hormone-charged teenagers to keep their distance and cover their faces.

The stakes are high.

If we cant open the school in a way they can stay here, weve got to either close the school or lock them down in dorm rooms, said Dr. Robert T. Chip Schooley, a professor of medicine who is helping guide UCSDs Return to Learn program.

Nobody wants to spend the next four years with what they hoped would be their college lives in their grandmothers attic with an iPad, looking at lectures on Zoom.

He added: Weve got a virus that only induces short-term immunity. People are already getting reinfected who were infected back in February.

At the moment , UCSD likes its odds for success.

The campus predicts that few of the 7,500 undergraduates moving into dorms will test positive for the virus. And those who do will be quickly isolated.

Maybe it will be 30, maybe it will be 20, maybe it will be 40, said Dr. Angela Scioscia, interim executive director of Student Health and Wellbeing at UCSD. I dont expect 100 (infections). That would be a bit of a surprise.

Theres concern that the campus, which has had 264 people test positive for the virus since March, is suffering from hubris. And much of that concern comes from within UCSD, which rarely airs its problems publicly.

More than 600 UCSD students, faculty, staff and alumni recently issued an open letter that asks the university to drop plans to repopulate its dorms and offer some in-person classes key parts of Return to Learn.

The universitys refusal to acknowledge fears about Return to Learn, as well as the release of recent data on the universitys budget and finances, suggests that the university is being run as a business rather than as a community and that financial incentives are being prioritized at the expense of community well-being, the open letter says.

The signatories included history professor Cathy Gere.

The idea that we can dictate student behavior and roll out technical solutions has been shown again and again to be demonstrably untrue, Gere told the Union-Tribune.

The full scope of the problem facing college campuses and their surrounding communities isnt known.

But a New York Times survey of more than 1,600 colleges and universities says that at least 88,000 students, faculty and staff have tested positive since the pandemic began, and that at least 60 have died.

The survey, last updated on Sept. 10, says SDSU has the highest number of infections of any college in California. UCSD, which has a medical school, two hospitals and a healthcare network, ranked third.

A series of jolting images has crystallized how indifferent many students are to the pandemic.

Several virus-positive students at Miami University in Ohio were filmed hosting a large party for classmates. At Indiana University, dozens of students were videotaped jammed together, mingling mask-less on party boats. And University of Wisconsin students were photographed moving out of a dorm due to an outbreak.

The images and the trouble at SDSU have not led UCSD to back away from Return to Learn. It also didnt deter Point Loma Nazarene University, which just added added 526 dorms students, and the University of San Diego, which is adding 519 this weekend.

Sage Greve, from Switzerland, prepares to make her bed in her dorm room at the University of San Diego on Friday, Sept. 18, 2020.

(Sandy Huffaker)

All three schools say young students often fare better academically when they live on or near campus. Students also have been pushing schools to open the dorms so that they can better experience college life.

UCSD also is flexing its muscles as one of the nations 10 largest research schools.

On average, the campus pulls in about $4 million a day in new research money, the majority of which goes to health and medicine. UCSD is helping run two major COVID-19 vaccine trials and is working on numerous therapeutic drugs to fight the virus.

The university also found ways to more quickly and cheaply test people for COVID-19, an advance its about to exploit. UCSD will test new undergraduate dorm students when they arrive and again 12 to 16 days later to make sure they catch those with the virus. It added the second test after noticing it was an effective strategy at other schools. Testing will continue, at intervals, through the fall.

Additionally, UCSD is making the most of a time advantage; its classes begin about a month later than most schools, so it has more time to tweak Return to Learn.

The university is putting together a system to continually check waste water for the presence of the virus, which can show up in fecal matter, highlighting the location of infections.

During a recent drill, UCSD unexpectedly found the virus in the Revelle College area at the south end of campus. The school quickly tested about 700 people and found two people who were the source of the reading. They were placed in isolation.

This totally transforms our ability to respond to an outbreak, sad Rob Knight, an acclaimed biologist UCSD hired five years ago for his expertise in studying microbes.

Everyone poops, right? This allows us to find populations (of people) who are infectious that are otherwise inaccessbile. The waste water signal shows up as much as a week before people start having symptoms and showing up in the clinic. So it gives us an excellent warning system, especially to test asymptomatic students.

UCSD hopes to have the system fully operational in October.

The university also got permission from the state last week to test out Apple and Google exposure notification technology, which uses Bluetooth technology in cellphones to inform students and staff when they have come into contact with someone who is infected.

If I get COVID-19, Im going to tell my family right away. But I may not remember or even know everybody that Ive encountered in the last two weeks, said Dr. Christopher Longhurst, the chief information officer and associate chief medical officer at UC San Diego Health.

Thats where this application can help notify the people whose names and phone numbers I dont have. Its designed to help the community, making it safer for everyone.

Its unclear whether the app will play a significant role in slowing the spread of COVID-19, despite the optimism of school officials. Users must choose to use the program, and some may take a pass because theyre concerned about preserving their privacy.

Apple, Google, the university and the state have said often that the cellphone technology does not collect identifying information, including location data.

Grayson Henard, from Fresno, unpacks his belongings at the Tower dormitory at UCSD on Saturday.

(Sandy Huffaker)

UCSDs strategy is deep, complex, and costly. But these kind of plans wont work without student buy-in, as the University of Illinois at Urbana-Champaign learned over the past couple of weeks.

Illinois has upwards of 40,000 students, all of whom were tested twice a week for the coronavirus. Many of them werent following anti-COVID-19 rules. By the time Labor Day rolled around, the school was reporting more than 1,000 infections.

The simple lesson: kids will be kids.

Despite reputation to the contrary, I dont think UCSD and SDSU students are very different, Longhurst said. Technology wont change that but can help limit the size of outbreaks.

The pressure is rising to get things right, which was evident Saturday at UCSD as the first undergraduates began moving into dorms.

They underwent drive-through testing at an isolated spot on campus. Then they reported for precisely scheduled move-in appointments that heavily emphasized social distancing. No one had to jockey for a parking spot.

Kim Peterson of Fountain Valley liked what she saw Saturday as she and her husband Gene pulled to the curb outside The Village residence hall to drop off their twin daughters, Grace and Ellie.

Weve been following the COVID situation very closely and feel really confident about UCSDs Return to Learn program, Kim Peterson said. Theyve been wonderful about educating parents and students about whats expected of students this fall.

Grace stood nearby, holding a pillow that shed brought from home.

UCSD is doing really good testing, she said. Im really excited to be here.

Staff writers Paul Sisson, Lyndsay Winkley and Jonathan Wosen contributed to this report.

Read more from the original source:
UC San Diego trying to avoid the coronavirus chaos that has upended SDSU - The San Diego Union-Tribune

Endometriosis Therapies Industry 2020 Global Market research report studies the latest Endometriosis Therapies industry aspects market size, share, trends, Opportunities and Strategies To Boost Growth, business overview, revenue, demand, marketplace expanding, technological innovations, recent development, and Endometriosis Therapies industry scenario during the forecast period (2020-2025).

Download Premium Sample of the Report: https://industrystatsreport.com/Request/Sample?ResearchPostId=12189&RequestType=Sample

Endometriosis Therapies Market unveils a succinct analysis of the market size, regional spectrum and revenue forecast about the Endometriosis Therapies market. Furthermore, the report points out major challenges and latest growth plans embraced by key manufacturers that constitute the competitive spectrum of this business domain.

Therapies used totreat endometriosisinclude: Hormonal contraceptives. Birth control pills, patches and vaginal rings help control the hormones responsible for the buildup ofendometrialtissue each month.In this report, 2018 has been considered as the base year and 2019 to 2025 as the forecast period to estimate the market size for Endometriosis Therapies.

This report studies the global market size of Endometriosis Therapies, especially focuses on the key regions like United States, European Union, China, and other regions (Japan, Korea, India and Southeast Asia).

This study presents the Endometriosis Therapies production, revenue, market share and growth rate for each key company, and also covers the breakdown data (production, consumption, revenue and market share) by regions, type and applications. history breakdown data from 2014 to 2019, and forecast to 2025.

In this study, the years considered to estimate the market size of Endometriosis Therapies are as follows:

History Year: 2014-2018 Base Year: 2018 Estimated Year: 2019 Forecast Year 2019 to 2025

For top companies in United States, European Union and China, this report investigates and analyzes the production, value, price, market share and growth rate for the top manufacturers, key data from 2014 to 2019.

In global market, the following companies are covered:

AbbVie Eli Lilly AstraZeneca Bayer Astellas Pharma Meditrina Pharmaceuticals Pfizer Neurocrine Biosciences Takeda Pharmaceutical

Market Segment by Product Type

Hormonal Contraceptives Gonadotropin-releasing Hormone (Gn-RH) Agonists Progestin Therapy Aromatase Inhibitors

Market Segment by Application

Hospital Clinic Other

Key Regions split in this report: breakdown data for each region.

United States China European Union Rest of World (Japan, Korea, India and Southeast Asia)

Endometriosis Therapies market report consists of the worlds crucial region market share, size (volume), trends including the product profit, price, value, production, capacity, capability utilization, supply, and demand. Besides, market growth rate, size, and forecasts at the global level have been provided. The geographic areas covered in this report:North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, Colombia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa).

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. Top-down and bottom-up approaches are used to validate the global market size market and estimate the market size for manufacturers, regions segments, product segments and applications (end users). All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or other factors are not accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from BrandEssenceResearch and presented in this report.

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation, extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub segments listed in this report. Extensive qualitative and further quantitative analysis is also done from all the numbers arrived at in the complete market engineering process to list key information throughout the report.

The study objectives are:

To analyze and research the Endometriosis Therapies status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast. To present the key Endometriosis Therapies manufacturers, presenting the sales, revenue, market share, and recent development for key players. To split the breakdown data by regions, type, companies and applications To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks. To identify significant trends, drivers, influence factors in global and regions To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market

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1 Market Overview1.1 Product Definition and Market Characteristics1.2 Global Endometriosis Therapies Market Size1.3 Market Segmentation1.4 Global Macroeconomic Analysis1.5 SWOT Analysis

3 Associated Industry Assessment3.1 Supply Chain Analysis3.2 Industry Active Participants3.2.1 Suppliers of Raw Materials3.2.2 Key Distributors/Retailers3.3 Alternative Analysis3.4 The Impact of Covid-19 From the Perspective of Industry Chain

4 Market Competitive Landscape4.1 Industry Leading Players4.2 Industry News4.2.1 Key Product Launch News4.2.2 Expansion Plans

5 Analysis of Leading Companies5.1 Company 15.1.1 Company 1 Company Profile5.1.2 Company 1 Business Overview5.1.3 Company 1 Endometriosis Therapies Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.1.4 Company 1 Endometriosis Therapies Products Introduction

5.2 Company 25.2.1 Company 2 Company Profile5.2.2 Company 2 Business Overview5.2.3 Company 2 Endometriosis Therapies Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.2.4 Company 2 Endometriosis Therapies Products Introduction

5.3 Company 35.3.1 Company 3 Company Profile5.3.2 Company 3 Business Overview5.3.3 Company 3 Endometriosis Therapies Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.3.4 Company 3 Endometriosis Therapies Products Introduction

5.4 Company 45.4.1 Company 4 Company Profile5.4.2 Company 4 Business Overview5.4.3 Company 4 Endometriosis Therapies Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.4.4 Company 4 Endometriosis Therapies Products Introduction

6 Market Analysis and Forecast, By Product Types6.1 Global Endometriosis Therapies Sales, Revenue and Market Share by Types (2015-2020)6.2 Global Endometriosis Therapies Market Forecast by Types (2020-2026)6.3 Global Endometriosis Therapies Sales, Price and Growth Rate by Types (2015-2020)6.4 Global Endometriosis Therapies Market Revenue and Sales Forecast, by Types (2020-2026)

7 Market Analysis and Forecast, By Applications7.1 Global Endometriosis Therapies Sales, Revenue and Market Share by Applications (2015-2020)7.2 Global Endometriosis Therapies Market Forecast by Applications (2020-2026)7.3 Global Revenue, Sales and Growth Rate by Applications (2015-2020)7.4 Global Endometriosis Therapies Market Revenue and Sales Forecast, by Applications (2020-2026)

8 Market Analysis and Forecast, By Regions8.1 Global Endometriosis Therapies Sales by Regions (2015-2020)8.2 Global Endometriosis Therapies Market Revenue by Regions (2015-2020)8.3 Global Endometriosis Therapies Market Forecast by Regions (2020-2026)Continued.

Read More: https://industrystatsreport.com/Lifesciences-and-Healthcare/Dynamic-Growth-On-Endometriosis-Therapies-Market-Size-and-Share/Summary

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Endometriosis Therapies Market Size to Expand Significantly by the End of 2025 - The Daily Chronicle

Philadelphia --Gavin Perrin has his work cut out for him this semester. The Susquehanna University sophomore is taking a hefty 22 credits in a demanding accounting program. But as he planned to head back to campus this month, the pandemic permitting, Perrin was thinking about the fun stuff: seeing all the friends he made last year, moving in with his new roommates, playing sports.

It's a far cry from Perrin's high school days.

"I was that type of kid in high school who would rather be anywhere else," Perrin said.

It's not that his high school was a bad place. The difference is him: "I feel like a new man."

Between his junior year of high school and his freshman year of college, Perrin lost more than 200 pounds. At 5-foot-10, the 19-year-old from Turbotville, Northumberland County, is down to 230 pounds. He says he feels healthier, more confident.

Gavin Perrin is photographed at his Turbotsville, Pennsylvania home Sept. 3, 2020. He has lost a substantial amount weight through bariatric surgery.(Photo: TOM GRALISH, TNS)

Perrin accomplished that through a lot of hard work that included diet change and exercise. But it probably wouldn't have happened so quickly without another strategy that's used to help only a small number of the estimated 4.5 million American children and teenagers with severe obesity: bariatric surgery. That's despite growing research that it is an effective, safe way to deal with a health problem that has reached epidemic proportions. Obesity increases the risk of hypertension, liver disease, diabetes, sleep apnea, and many other health problems, even among teens.

The American Academy of Pediatrics in December came out in support of bariatric surgery as an "evidence-based effective treatment of severe obesity" and said greater access to the surgery for pediatric patients ages 13 and older "is urgently needed." There is no authoritative count of how many of these surgeries are performed each year on teenagers, but estimates range from 450 to about 1,600. Most experts agree it's less than 1% of the youngsters who might benefit.

"It's definitely underutilized," said Elizabeth Parks Prout, medical director of Children's Hospital of Philadelphia's Adolescent Bariatric Surgery Program, a joint effort with the Hospital of the University of Pennsylvania. "We're not treating everyone who needs treatment, unfortunately."

'A tool for change'

Most teens who undergo bariatric surgery, like Perrin, have the gastric sleeve procedure, in which 70% to 80% of the stomach is permanently removed. Not only is the size of the stomach greatly reduced, but, especially significant, the surgery also affects hormonal balance, including the production of ghrelin, often referred to as the hunger hormone.

Surgery along with lifestyle changes result in a 20% to 30% average weight loss for adolescent patients, Prout said. Lifestyle changes alone aren't effective for long-term obesity treatment, many experts say.

A growing body of research shows there are few post-bariatric surgery complications, though many programs recommend nutritional supplements in response to concerns about postsurgery deficiencies.

Money, not safety, is one reason few teens get this surgery. It's not unusual for insurers to turn down adolescents for the surgery, according to the AAP, especially children from low-income families and children of color who may be stymied by complex, and at times costly, insurance appeals, or inconsistent coverage policies. These families may also lack access to a bariatric surgery program near them.

Some parents and patients fear going under the knife for something they might think could be handled without surgery. In addition, doctors involved in bariatric programs say other physicians often hesitate to refer younger patients, in part due to misunderstanding about the surgery.

"It's a surgery to help you to be able to be effective in the changes in your diet and exercise," Prout said. "The surgery is not a cure. The surgery is a tool for change."

Ann Rogers, director of the Penn State Surgical Weight Loss Program, said she thinks the stigma of obesity can extend to its treatment.

"Obesity isn't a choice. It's not a lifestyle people want to embrace," Rogers said. "It's a chronic and recurring medical condition, just like cancer. So if we have medical therapies that are designed to treat medical problems, we should use them."

'What am I waiting for?'

Lyndsey Gibb, 17, said she's always been "a bigger kid," at least since she was a toddler. "It was something that continued to get out of control as I grew when I hit the teenage years. That's especially when it got bad," she said.

The Dillsburg, York County, teenager tried various diet and exercise programs and went to multiple nutritionists, but nothing ever kept the weight off. Then a couple of years ago, her father had bariatric surgery. As her dad shed weight, she noticed other changes in him. He was more confident, less self-conscious about what he wore, less restricted in the things he would do. She decided she wanted that for herself.

Gibb had her surgery last December at Hershey Medical Center with Rogers. Since then, she's lost 115 pounds and intends to shed another 60. Her BMI went from almost 53 to 36. (Severely obese is considered to start at a BMI of 35 to 40.)

"I definitely feel a lot better, more so confidence-wise than health-wise," Gibb said. "Health-wise, I feel like I can do more, but just being more comfortable with what I look like and what I can wear makes me feel a lot better."

Gibb said she is excited that she can now wear stylish brands like Simply Southern that she always liked, but didn't come in her old size. She gave up riding horses because of her weight. She thinks that could be an option again. Just walking is more enjoyable.

She's beginning her senior year at Northern York High School. COVID-19 permitting, she's looking forward to the prom. Growing up in a rural area, Future Farmers of America is an important activity for her. It involves speaking in front of large groups of people.

"It will help if I feel better about how I look," she said. "I'll be more confident in what I'm doing, and hopefully I can even be better at what I'm doing because of it."

To those who would say she was too young to have this kind of surgery, she has a ready answer.

"What am I waiting for in my life? I've dealt with this for how many years now? My dad got it when he was 40-something years old. It's either I live with how I am and continue to go up and down, or give this a shot and be able to improve my quality of life sooner."

Gavin Perrin is photographed at his Turbotsville, Pennsylvania home Sept. 3, 2020. He has lost a substantial amount weight through bariatric surgery.(Photo: TOM GRALISH, TNS)

A new start

Perrin started his battle with weight at a young age, too. From ages 4 to 15, he participated in a medical weight-loss clinic program where he was given nutrition counseling. Finally, he was told there was nothing more they could do for him. By the time he got to the CHOP bariatric program, his BMI was 65.

"I had high blood pressure. I was borderline diabetic. Even walking around, my feet would burn up. I'd get tired really quick. I did try to play sports, but I couldn't last," Perrin said. "My size definitely bothered me. I could tell from a young age there were these differences, and I wasn't the same as everybody else."

Eating in public places made him feel self-conscious. "Even if they're not looking at you, you felt as if all eyes were on you."

In elementary and middle school, he had temper problems. He thinks his weight had something to do with it.

In high school, he found himself not wanting to go most of the time. He didn't ask anyone to the prom, and no one asked him.

He was a sophomore when he entered CHOP's program. He spent about a year in the presurgery program, which included education and lifestyle changes like a high-protein diet, vitamins, and medication. He had his doubts, given his past experiences. But for the first time, the pounds started coming off _ and staying off. He also was no longer prediabetic, and his blood pressure returned to normal.

"I thought, 'These are people I can trust.'"

By the time he arrived for freshman year at Susquehanna University, Perrin was very different from the kid who underwent weight-loss surgery.

"No one knew me. I could kind of reinvent myself," Perrin said.

After taking charge of his body and his health, "I felt like I could really talk to anybody. I didn't have trouble going out and meeting new people."

The high schooler who preferred to stay in his room became a college student who set goals of meeting as many people as he could. He was a regular at the campus gym. He joined the rugby team and played pickup basketball.

Last month, classes at Susquehanna started online, and Sept. 20 is his back-to-campus day. His roommates will be waiting. He's got a new job as an academic coach for freshman business students. Perrin's ready for whatever the future might bring.

"As long as coronavirus doesn't get in the way," he said, "I think these next couple years are going to be the best time of my life."

___

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For teens with severe obesity, bariatric surgery works, but is rarely used. Experts say that needs to change - The Detroit News

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced five-year survival results from the pivotal Phase 3 KEYNOTE-024 trial, which demonstrated a sustained, long-term survival benefit and durable responses with KEYTRUDA, Mercks anti-PD-1 therapy, versus chemotherapy as first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] 50%) with no EGFR or ALK genomic tumor aberrations. At five years, the overall survival (OS) rate was twice as high for patients who received KEYTRUDA (31.9%; n=154) versus chemotherapy (16.3%; n=151). KEYTRUDA also reduced the risk of death by 38% (HR=0.62 [95% CI, 0.48-0.81) versus chemotherapy, with a median OS of 26.3 versus 13.4 months. Results from KEYNOTE-024 represent the longest follow-up and first-ever five-year survival data for an immunotherapy in a randomized Phase 3 study for the first-line treatment of NSCLC.

Before 2014, the five-year survival rate for patients in the U.S. with advanced non-small cell lung cancer was only 5%. Data presented today from KEYNOTE-024 showed that 31.9% of patients treated with KEYTRUDA were alive at five years, said Martin Reck, M.D., Ph.D., Lung Clinic Grosshansdorf, German Center of Lung Research. Survival outcomes in these patients with metastatic lung cancer did not seem possible to many oncologists, including myself, several years ago. The long-term survival benefit achieved with KEYTRUDA as a single agent in this study is a great example of the progress we have made in lung cancer to provide patients with more time without disease progression and a chance at a longer life.

KEYTRUDA has become foundational in the treatment of metastatic lung cancer based on the sustained, long-term survival benefit demonstrated in our clinical trials. These new, first-of-their-kind five-year survival results from KEYNOTE-024 add to our understanding of the important role that KEYTRUDA now has in the treatment of lung cancer, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. It is particularly noteworthy that at five years, 81.4% of patients who completed two years of treatment with KEYTRUDA were alive and nearly half of these patients remained treatment-free, representing an encouraging new precedent in the first-line metastatic non-small cell lung cancer setting. We are grateful to the many patients and health care providers in this trial and our other trials for their essential role in these studies and in advancing cancer care.

These late-breaking data were presented as a proffered paper at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on Monday, Sept. 21 (Abstract #LBA51). As announced, data spanning more than 15 types of cancer will be presented from Mercks broad oncology portfolio and investigational pipeline at the congress. A compendium of presentations and posters of Merck-led studies is available here. Follow Merck on Twitter via @Merck and keep up to date with ESMO news and updates by using the hashtag #ESMO20.

Five-Year Overall Survival Data From KEYNOTE-024 (Abstract #LBA51)

New data from KEYNOTE-024 (ClinicalTrials.gov, NCT02142738) demonstrated a sustained, long-term survival benefit with KEYTRUDA versus chemotherapy after 59.9 months of median follow-up (range, 55.1 to 68.4). The pivotal Phase 3, randomized, open-label trial evaluated KEYTRUDA monotherapy versus standard of care platinum-based chemotherapy as first-line treatment in patients with metastatic NSCLC whose tumors express high levels of PD-L1 (TPS 50%) with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA reduced the risk of death by 38% (HR=0.62 [95% CI, 0.48-0.81]) versus chemotherapy alone, with a median OS of 26.3 versus 13.4 months. The five-year OS rate was 31.9% for patients who received KEYTRUDA versus 16.3% for those who received chemotherapy. The OS benefit was observed, despite a 66% (n=99/150) effective crossover rate from chemotherapy to subsequent anti-PD-1/PD-L1 therapy. KEYTRUDA also reduced the risk of disease progression or death by half (HR=0.50 [95% CI, 0.39-0.65]) versus chemotherapy as assessed by investigators, with a median progression-free survival of 7.7 versus 5.5 months. The objective response rate (ORR) was 46.1% for KEYTRUDA versus 31.1% for chemotherapy. The median duration of response was 29.1 months (range, 2.2 to 60.8+) for KEYTRUDA versus 6.3 months (range, 3.1 to 52.4) for chemotherapy.

Of the patients who completed two years of treatment with KEYTRUDA (n=39/154), 81.4% were alive at five years and nearly half (46%) remained treatment-free. These data suggest that patients who completed two years of treatment with KEYTRUDA experienced a long-term OS benefit. The ORR was 82% for patients who completed two years of treatment with KEYTRUDA. Additionally, 12 patients received a second course of therapy.

No new safety signals for KEYTRUDA were identified with long-term follow-up. Among all patients who were treated, 31.2% of those who received KEYTRUDA and 53.3% of those who received chemotherapy experienced Grade 3-5 treatment-related adverse events (TRAEs). Among patients who completed two years of treatment with KEYTRUDA, Grade 3-5 TRAEs occurred in 15.4%.

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10 to 15% of all lung cancers. Before 2014, the five-year survival rate for patients diagnosed in the U.S. with NSCLC and SCLC was estimated to be 5% and 6%, respectively.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

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First-Line Treatment With Merck's KEYTRUDA (pembrolizumab) Doubled Five-Year Survival Rate (31.9%) Versus Chemotherapy (16.3%) in Certain Patients...

The global Adenomyosis Treatment Market is expected to reach at xx % in the forecast period, stated by a recent study of Contrive Datum Insights. It offers a complete overview of the global market along with the market influencing factors. Furthermore, it offers a detailed description of the global market with respect to the dynamics of the market such as internal and external driving forces, restraining factors, risks, challenges, threats, and opportunities. Analysts of this research report are predicting the financial attributes such as investment, pricing structures along with profit margin. This research document has been prepared by using advanced research methodologies like primary and secondary research.

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Chapter 5 Adenomyosis Treatment Market Application and Business with Potential Analysis

Chapter 6 Global Adenomyosis Treatment Market Segment, Type, Application

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Adenomyosis Treatment Market to Witness a Pronounce Growth During (2020-2027) | Bayer AG, Ferring BV, Johnson & Johnson, Novartis - Verdant News

So, at long last the children are gone back to school. Long may it last! I think nearly every parent in the country swore that everything was going to change when the kids went back to school. Back to healthy eating, getting in the 5km walk a day and drinking gallons of water, all in the hope of losing the covid stone.In reality it may have been a case of, peace at last so time to break out the choccie biscuits. Before you know it, you wake up and its Tuesday and you cant start a diet on a Tuesday.So, you may overindulge over the next few days with the mindset of starting again next Monday, and this pattern goes on week after week. Does this sound all too familiar? As a busy mum of five, I totally get this and Im here to help you with my tips and ideas to keep you reach your goals for a happy and healthy you.

1. START WITH A PLANOne of the best things you can do for yourself is to get into the habit of planning your family meals. This will save you time and money. Planning meals in advance ensures you use up the ingredients you have before buying more. Get the whole family involved by allowing everyone pick a meal. There is a meal planner in my 28-day rescue plan, download it free from my website and get writing!

2. WRITE A LISTWrite a shopping list for the ingredients you need to put your meal plan into action. This will save you time wandering around the shop wondering what to buy and save you money as you will be less likely to put unwanted items in your trolley. And of course, none of us want to be hanging around the supermarket longer than we need to.

3. PLAN FOR LEFTOVERSPlan for leftovers to be used the next day as lunch. For example leftover chili is delicious the next day when heated in a wholemeal pitta bread or wrap with grated cheese, avocado and salad. Leftover roast chicken is so versatile and can be used in salads or wraps. My personal favorite is to make an egg fried rice with it.

4. PREPARE FOOD IN BATCHESIf your family are great at coming up with the meal plan ideas but not so great at helping to prep or cook it, then lighten your load by prepping once to eat multiple times.Chop and wash a variety of veg all at once, then place them in an airtight container in the fridge to use as snacks. Carrots, celery, peppers all make great snacks to dip in hummus or cream cheese.Double your recipe ingredients and store them in the fridge or freezer and you will have a meal ready to be cooked when you want it. This works great for curries. Just pop your chicken and veg that has been marinating in the lovely spices into a pot with a tin of coconut milk, simmer for 20 minutes and you have a tasty meal on the table that the whole family will love. Check out my curry recipe on my website http://www.thenutricoach.ie

5. ENSURE YOU ARE GETTING A WIDE RANGE OF NUTRIENTSIts important to remember there is no specific food or supplement that will help you lose weight or boost your immune system, contrary to what you see on social media. However, a healthy balanced diet thats low in sugar and processed food and high in nutrients that support the immune system such as, vitamin C (berries, tomatoes, peppers, citrus fruit) vitamin A (sweet potato, spinach) vitamin D (oily fish, mushrooms) zinc (meat, shellfish, dairy) is the best thing you can do for your immune system and your waistline.

6. EAT REGULARLYAs tempting as it may be to restrict your calorie intake, skipping meals is never a good idea. Going long periods without eating causes your blood sugar to drop, which leads to fatigue and cravings for sugary snacks and stimulants. Aim for three main meals a day and include a maximum of two nutritious snacks, such as a piece of fruit with four or five nuts, vegetable crudits with hummus or sliced apple dipped in nut butter or try out my no bake energy balls!

7. EAT A SOURCE OF PROTEIN WITH EVERY MEAL OR SNACKWhen you eat carbohydrates alone, they quickly get digested and converted into sugar which is then absorbed into your blood stream causing a spike in blood sugar. However including a source of protein with your meal or snack slows down digestion. This leads to a slower absorption of carbohydrates, therefore a lower rise in blood sugar, so less of the fat storing hormone insulin is needed, and protein will help you feel full for longer resulting in less snacking.

8. STAY HYDRATEDDrinking water has many benefits, including boosting your metabolism and suppressing your appetite. When you dont drink enough water, your body receives mixed signals from the hypothalamus, which is the part of the brain that regulates appetite and thirst. A lot of the time when we think we are hungry, we are actually dehydrated. Aim to drink two litres of water a day. This can be achieved by starting your day with hot water and lemon, adding lemon slices, cucumber and mint leaves to a jug of water and sipping throughout the day and having some herbal teas.

9. FOLLOW THE HEALTHY PLATE GUIDEThe healthy plate guide is an easy way to make sure you are having a well-balanced meal, just fill half your plate with vegetables, a quarter of your plate protein/healthy fats e.g. chicken, meat, fish, eggs, lentils, and a quarter of your plate low GL carbohydrates e.g. sweet potato, brown pasta or rice, quinoa.Are you struggling to get back to healthy eating and getting your weight back to what it was pre-covid? Why not schedule in an appointment with The Nutri Coach! There is no time like the present. My clinic open and I am taking bookings for new and existing clients, so just pop me a message if you would like to schedule an appointment. Contact details below.

Debbie Devane from The Nutri Coach is a qualified Nutritional Therapist and health & lifestyle coach, Debbie runs her clinic from the Glenard Clinic in Mountmellick and also offers one to one and group online consultations. Debbie is also Nutritionist to the Offaly GAA senior footballers.For more information or to make an appointment email Debbie atinfo@thenutricoach.iePh: 086-1720055Facebook: The Nutri Coach @debbiedevanethenutricoachInstagram: the_nutricoachFor more information or to download your copy of Debbie's 28 day rescue plan go to http://www.thenutricoach.ie

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A new routine to lose the Covid stone - Leitrim Observer

ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, Sept. 22, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated(Nasdaq: VRTX) today announced the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001, an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy for the treatment of severe sickle cell disease (SCD).

PRIME is a regulatory mechanism that provides early and proactive support to developers of promising medicines, to optimize development plans and speed up evaluations so these medicines can reach patients faster. The goal of PRIME is to help patients benefit as early as possible from innovative new therapies that have demonstrated the potential to significantly address an unmet medical need. PRIME designation was granted based on clinical data from CRISPR and Vertexs ongoing Phase 1/2 trial of CTX001 in patients with severe SCD.

About CTX001CTX001 is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy that is being evaluated for patients suffering from transfusion-dependent beta thalassemia (TDT) or severe SCD, in which a patients hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth, which then switches to the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for TDT patients and reduce painful and debilitating sickle crises for SCD patients.

Based on progress in this program to date, CTX001 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), and Orphan Drug Designation from the European Commission, for both TDT and SCD.

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex. CTX001 is the most advanced gene-editing approach in development for TDT and SCD.

About CLIMB-111The ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with TDT. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-121The ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with severe SCD. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About the Gene-Editing Process in These TrialsPatients who enroll in these trials will have their own hematopoietic stem and progenitor cells collected from peripheral blood. The patients cells will be edited using the CRISPR/Cas9 technology. The edited cells, CTX001, will then be infused back into the patient as part of a stem cell transplant, a process which involves, among other things, a patient being treated with myeloablative busulfan conditioning. Patients undergoing stem cell transplants may also encounter side effects (ranging from mild to severe) that are unrelated to the administration of CTX001. Patients will initially be monitored to determine when the edited cells begin to produce mature blood cells, a process known as engraftment. After engraftment, patients will continue to be monitored to track the impact of CTX001 on multiple measures of disease and for safety.

About the CRISPR-Vertex CollaborationCRISPR Therapeutics and Vertex entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first treatment to emerge from the joint research program. CRISPR Therapeutics and Vertex will jointly develop and commercialize CTX001 and equally share all research and development costs and profits worldwide.

About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR Therapeutics Forward-Looking Statement This press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, as well as statements regarding CRISPR Therapeutics expectations about any or all of the following: (i) the status of clinical trials (including, without limitation, the expected timing of data releases) and discussions with regulatory authorities related to product candidates under development by CRISPR Therapeutics and its collaborators, including expectations regarding the benefits of PRIME designation; (ii) the expected benefits of CRISPR Therapeutics collaborations; and (iii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: potential impacts due to the coronavirus pandemic, such as the timing and progress of clinical trials; the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients (as is the case with CTX001 at this time) not to be indicative of final trial results; the potential that CTX001 clinical trial results may not be favorable; that future competitive or other market factors may adversely affect the commercial potential for CTX001; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading Risk Factors in CRISPR Therapeutics most recent annual report on Form 10-K, quarterly report on Form 10-Q and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

About VertexVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 10 consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Vertex Special Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding CTX001s PRIME designation or its development, the potential benefits of CTX001, our plans and expectations for our clinical trials and clinical trial sites, and the status of our clinical trials of our product candidates under development by us and our collaborators, including activities at the clinical trial sites and potential outcomes. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs, including its programs with its collaborators, may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under Risk Factors in Vertex's annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through the company's website at http://www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.(VRTX-GEN)

CRISPR Therapeutics Investor Contact:Susan Kim, +1 617-307-7503susan.kim@crisprtx.com

CRISPR Therapeutics Media Contact:Rachel EidesWCG on behalf of CRISPR+1 617-337-4167reides@wcgworld.com

Vertex Pharmaceuticals IncorporatedInvestors:Michael Partridge, +1 617-341-6108orZach Barber, +1 617-341-6470orBrenda Eustace, +1 617-341-6187

Media:mediainfo@vrtx.comorU.S.: +1 617-341-6992orHeather Nichols: +1 617-839-3607orInternational: +44 20 3204 5275

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CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to...

"The CRISPR QC applications clearly demonstrate that our differentiated, high value, Cardean Transistor technology can be manufactured at scale and adopted to pressing market applications with major unmet needs." - Rob Lozuk, CBO of Cardea

SAN DIEGO (PRWEB) September 22, 2020

CRISPR QC, a pioneer in streamlining CRISPR quality control testing, announced today the launch of CRISPR-BIND, a rapid and highly sensitive tool to characterize gRNA and CRISPR-Cas interactions. CRISPR-BIND is the first in a suite of Quality Control capabilities. Built upon Cardeas Biology-gated Transistors (Cardean Transistors) and an automated, high throughput liquid handler, CRISPR-BIND generates highly sensitive electronic signals rather than optics or labels to enhance CRISPR researchers ability to perform rapid assessments of gRNA Cas interactions directly at the lab bench. This includes, but is not limited to, monitoring the interactions and stability of a variety of modified gRNAs with engineered Cas enzymes. CRISPR QC will commercialize CRISPR-BIND in the United States along with the world leading CRISPR experts at COBO Technologies who will offer the product across Europe.

There is a high demand in the European market to rapidly characterize gRNAs and Cas variants for CRISPR-based applications, says Jens-Ole Bock, CEO and Founder of COBO Technologies. This powerful and innovative CRISPR QC platform will support the growing need for new sensitive QC solutions in the pharma and biotech segments and add an important new tool to the CRISPR research community.

CRISPR QC is Cardeas first commercial partner and CRISPR-BIND is the first of a series of CRISPR QC applications that will come out of the partnership.

"Upcoming product generations will offer alternate ways and perspectives on what the optimal guide RNA and Cas combination will be in varying environmental conditions and provide the user with insight to the ideal solutions for different CRISPR applications. Users will be able to both work in amplicons of rare samples, as well as in whole genomic unamplified DNA, says Rob Lozuk, CBO of Cardea. The CRISPR QC applications clearly demonstrate that our differentiated, high value, Cardean Transistor technology can be manufactured at scale and adopted to pressing market applications with major unmet needs. In addition, were thrilled to be working with CRISPR QC to develop this breakthrough technology and partner with COBO Technologies as their European distributor to ensure global access to these innovative technologies.

This is the first of many commercial partnerships coming out of the Cardea Innovation Partnership Program, says Michael Heltzen, CEO and Co-founder of Cardea. Im pleased with the markets response and we will continue to partner with world leading companies to deliver breakthrough applications to disrupt markets.

CRISPR-BIND will initially be available to a select number of industry leaders and CRISPR-focused academic research groups. For more information about CRISPR-BIND, visit CRISPR QCs website.

About Cardea BioCardea is linking biology directly up to computers for the very first time by building a Tech+Bio Infrastructure and offering chipsets based on proprietary Biology-gated Transistors, or Cardean Transistors. These transistors leverage graphene, a nanomaterial that in contrast to the common semiconductor material silicon, is biocompatible and a near perfect conductor due to only being one atom thick. It that way replaces optical static observations with interactive live-streams of multi-omics signal analysis, representing a new life science observation paradigm where multi-omics data-streams will be the new norm instead of most of the current standard technologies that are single-omics frozen-in-time datasets. Together with their Innovation Partners, Cardea can link biology directly to compute power and convert real-time biological signals to digital information, allowing for immediate biological insight and a new generation of applications Linking up to Life.

About CRISPR QCCRISPR QC is pioneering streamlined CRISPR quality control tools to accelerate research while improving accuracy and performance. With capabilities stretching from optimizing CRISPR designs and identifying the most optimal conditions to determining binding interactions and running quantitative analysis of amplicons and whole genomic DNA, their services save researchers both time and resources. Powered by Cardea and built upon automated high throughput liquid handling systems, their platform is optics-free and entirely electronic to eliminate risk of human errors and biology-distorting sample preparation.

Partnership inquiries Rob LozukChief Business Officerpublicrelations@cardeabio.com

Media inquiriesAmanda ZimmerMarketing Managermarketing@cardeabio.com

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Cardea Bio Announces Global Launch of First Proprietary Powered by Cardea Product in Partnership with CRISPR QC - PR Web

Dublin, Sept. 21, 2020 (GLOBE NEWSWIRE) -- The "Global CRISPR & Cas Genes Market Size, Share & Trends Analysis by Product & Service (Vector-based Cas, DNA-free Cas, Cell Line Engineering), Application, End Use, and Segment Forecasts 2020-2027" report has been added to ResearchAndMarkets.com's offering.

The global clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR-associated (Cas) genes market size is expected to reach USD 4.88 billion by 2027, expanding at a CAGR of 16.6% from 2020 to 2027.

CRISPR & Cas Genes Market Report Highlights

The product segment is anticipated to dominate the market throughout the forecast period. This is attributed to the presence of enhanced individual products that can serve multiple purposes including genome engineering, specific genome cleavage using gRNAs, easy gene knockouts, along with reduced off-target cutting, and increased specificity

Cell line engineering services accounted for the largest market share in 2019. The development of this technology has simplified the genome engineering process to a large extent

In biomedical applications, genome engineering held the largest revenue share in 2019 as a result of an increase in the adoption of genome editing techniques for modifications in germline and therapeutics development

Recent advancements in CRISPR/Cas genome editing allow targeted modification in crops, thereby promising crop improvement and revenue generation in the market

A significant number of research studies carried out to develop disease-specific novel therapies and the presence of a huge clinical pipeline that integrates the application of this gene-editing technology are expected to boost revenue generation for the biotechnology and pharmaceutical companies segment

Asia Pacific is anticipated to witness the fastest growth over the forecast period. China holds a significant position in the CRISPR market and is increasingly exploring genome-editing for the development of medicines. The country has launched several CRISPER-based clinical trials, especially for cancer treatment.

Rise in the adoption of CRISPR technology in epigenetics, therapeutics, human germline editing, plant genome editing, and other fields of biotechnology is expected to drive the market.

Presence of a large number of service providers that provide knockout, knock-in, gene repression, gene activation, and other cell line engineering services propel the growth of cell line engineering services. In biomedical applications, genome engineering held the largest revenue share in 2019. Adoption of gene editing techniques for human- and non-human-based genomic engineering is one of the key factors that drive the segment.

The molecular scissor can facilitate the detection of viruses, allowing the development of cost-effective, robust, and rapid point-of-care diagnostics. It allows the detection of viruses at a level of molecular concentration that researchers rarely assess. Sherlock Bioscience estimated that a CRISPR-powered diagnostic test would be available in the future at a reasonable price. In recent times, the most important innovation has been the development of a test for COVID-19.

In March 2020, Mesa Biotech announced FDA authorization for its Accula device, a hand-held COVID-19 diagnostic test. Similarly, in April 2020, CSIR lab announced the development of a paper-strip test for Covid-19 that uses CRISPR-Cas9 to target and identifies the genomic sequences of the virus. Unlike the PCR tests, this test is available at a very low price, USD 6.59 (INR 1 = USD 0.013). Therefore, such initiatives are expected to encourage other players to leverage this crisis and launch novel products.

Key Topics Covered:

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Chapter 1 Research Methodology

Chapter 2 Executive Summary2.1 Market Snapshot, 2019 (USD Million)

Chapter 3 Crispr And Cas Genes Market Variables, Trends & Scope3.1 Market Trends & Outlook3.2 Market Segmentation & Scope3.3 Market Lineage Outlook3.3.1 Parent Market Outlook3.3.2 Related/Ancillary Market Outlook3.4 Crispr And Cas Genes: Patent Landscape3.4.1 By End - Use Settings3.4.2 By Variants Of Crispr Enzymes3.5 Penetration And Growth Prospect Mapping, By Biomedical Applications, 20193.6 Potential Threat Analysis To Crispr Technology3.6.1 Variations In The Crispr System3.7 Investors Perspective Analysis3.8 User Perspective Analysis3.9 Technology Mapping In Crispr Genome Editing Workflow3.10 Developments And Innovations For Analysis Of Off - Target Effects3.11 Crispr Technologies: Clinical Penetration3.11.1 Human Therapeutics3.11.2 Diagnostics3.11.3 Microbiome Research And Drug Resistance3.11.4 Animal Disease Models

Chapter 4 Industry Outlook4.1 Market Dynamics4.1.1 Market Driver Analysis4.1.1.1 Rising Adoption In Diverse Fields Of Biotechnology4.1.1.1.1 Epigenetics4.1.1.1.2 Medicine4.1.1.1.3 Human Germline Editing4.1.1.1.4 Tool For Qualitative And Quantitative Plant Genome Editing4.1.1.2 Technological Advancements In Crispr4.1.1.3 Introduction Of Anti - Crispr Protein4.1.1.4 Ongoing Competition For Crispr Commercialization4.1.2 Market Restraint Analysis4.1.2.1 Off - Target Effects Of Crispr Technology4.1.2.2 Intellectual Property Disputes Pertaining To Cas4.1.2.3 Ethical Concerns And Implications With Respect To Human Genome Editing4.1.3 Market Opportunity Analysis4.1.3.1 Expanding Gene & Cell Therapy Area4.1.3.2 Government Fund In Genomic R&D4.1.4 Market Challenge Analysis4.1.4.1 Risks Pertaining To The Usage Of Genetically Modified Food4.2 Policy Making & Regulation For Genetic Modification Using Crispr4.3 Porter's Five Forces Analysis4.4 SWOT Analysis, By Factor (Political & Legal, Economic, And Technological)

Chapter 5 Competitive Landscape5.1 Companies (Diagnostic & Drug Developers) Leveraging Gene Editing Technologies5.2 Major Deals & Strategic Alliances Analysis5.3 Market Entry Strategies5.3.1 Crispr Therapeutics: Business Translation5.3.2 Crispr Gene Editing Companies' Toolboxes5.4 Crispr And Cas Genes Market: Pipeline Analysis5.4.1 Editas Medicine5.4.2 Intellia Therapeutics, Inc.5.4.3 Crispr Therapeutics5.4.4 Caribou Biosciences, Inc.5.4.5 Egenesis5.4.6 Beam Therapeutics5.4.7 Ksq Therapeutics5.4.8 Cibus

Chapter 6 Product & Service Business Analysis6.1 Crispr And Cas Genes Market: Product & Service Movement Analysis6.2 By Product6.2.1 Global Crispr And Cas Genes Products Market, 2016 - 2027 (USD Million)6.2.2 Kits & Enzymes6.2.3 Global Crispr And Cas Genes Kits And Enzymes Market, 2016 - 2027 (USD Million)6.2.3.1 Vector - Based Cas96.2.3.2 Dna - Free Cas96.2.4 Libraries6.2.5 Design Tools6.2.6 Antibodies6.2.7 Others6.3 By Service6.3.1 Global Crispr And Cas Genes Service Market, 2016 - 2027 (USD Million)6.3.2 Cell Line Engineering6.3.3 Grna Design6.3.4 Microbial Gene Editing6.3.5 Dna Synthesis

Chapter 7 Application Business Analysis7.1 Crispr And Cas Genes Market: Application Movement Analysis7.2 Biomedical7.2.1 Global Crispr And Cas Genes Market For Biomedical, 2016 - 2027 (USD Million)7.2.2 Genome Engineering7.2.3 Disease Model Studies7.2.4 Functional Genomics7.2.5 Epigenetics7.2.6 Others7.3 Agriculture

Chapter 8 End - Use Business Analysis8.1 Crispr And Cas Genes Market: End - Use Movement Analysis8.1.1 Biotechnology & Pharmaceutical Companies8.1.2 Academics & Government Research Institutes8.1.3 Contract Research Organizations (Cros)

Chapter 9 Regional Business Analysis

Chapter 10 Company Profiles

Astrazeneca

Addgene

Caribou Biosciences, Inc.

Cellectis

Crispr Therapeutics

Editas Medicine, Inc.

Egenesis

F. Hoffmann - La Roche Ltd.

Horizon Discovery Group Plc

Genscript

Danaher Corporation

Intellia Therapeutics, Inc.

Lonza

Merck Kgaa

New England Biolabs

Takara Bio, Inc.

Thermo Fisher Scientific, Inc.

Synthego

Mammoth Biosciences

Inscripta, Inc.

Cibus

Beam Therapeutics

PlanteditVertex Pharmaceuticals Incorporated

Hera Biolabs

Origene Technologies, Inc.

Recombinetics, Inc.

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Global $4.88 Bn CRISPR & Cas Genes Market to 2027: Opportunities in the Expanding Gene & Cell Therapy Area & Government Fund In Genomic R&D - Yahoo...

With 75 percent of current S&P 500 companies expected to disappear until 2027, according to research by McKinsey. The only constant in our world is changing, the pace of change has been expediting significantly over the past years, fueled by huge investments in technology and science, easier access to truly global markets, and a general cultural shift towards innovation among other key drivers are helping to rise of CRISPR Genome Editing market.

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CRISPR Genome Editing Market Research study offers a comprehensive evaluation of the Market and comprises a future trend, current growth factors, focused opinions, details, and industry certified market data, sales, revenue, production and forecast and more.

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CRISPR Genome Editing Market Segmentation by Product Type and Application

The CRISPR Genome Editing report focuses on consumers behaviors at a specific requirement by end-use, usage pattern providing more insights about its competitive landscape such as By Product Type(Genetic Engineering, Gene Library, Human Stem Cells) and Application(Biotechnology Companies, Pharmaceutical Companies).

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CRISPR Genome Editing Market Segmentation by Regions

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Key Points Covered in CRISPR Genome Editing Market Report:

13.Current and historical revenues

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Market trends and outlook coupled with factors driving and restraining the growth of the CRISPR Genome Editing market - The Daily Chronicle

GlobalCRISPR and CAS Gene MarketResearch Report is a resource, which provides current as well as upcoming technical and financial details of the industry to 2027. This report gives you so important and essentials data of Market size, share, trends, Growth, applications, forecast and cost analysis. Delivery development in North America, China, Europe, and South East Asia, Japan as well as in the Globe. The report proves to be indispensable when it comes to market definition, classifications, applications and engagements.

The market report also computes the market size and revenue generated from the sales. The industry analysis report presents the key statistics on the market status of global and regional manufacturers and also acts as a valuable source of leadership and direction. What is more, the CRISPR and CAS Gene market report analyses and provides historic data along with the current performance of the market.

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Global CRISPR and CAS Gene Market competition by Top Key Players: Caribou Biosciences Inc., CRISPR Therapeutics, Mirus Bio LLC, Editas Medicine, Takara Bio Inc., Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc.

CRISPR and CAS Gene Market section by Region:

Segmentation: The report has been separated into different categories, such as product type, application, end user, and region. Every segment is evaluated based on the CAGR, share and growth potential. In the regional analysis, the report highlights the prospective region, which should generate opportunities in the global CRISPR and CAS Gene market in the years to come. This segmented analysis will surely prove to be a useful tool for readers, stakeholders and market participants to get a full picture of the CRISPR and CAS Gene global market and its growth potential in the years to come.

The CRISPR and CAS Gene Market report offers a plethora of insights which include:

Changing consumption patterns among individuals globally.

Historical and future progress of the global CRISPR and CAS Gene market.

Region-wise and country-wise segmentation of the CRISPR and CAS Gene market to understand the revenue, and growth lookout in these areas.

Accurate Year-on-Year growth of the global CRISPR and CAS Gene market.

Important trends, including proprietary technologies, ecological conservation, and globalization affecting the global CRISPR and CAS Gene market.

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Important Information that can be extracted from the Report:

Assessment of the COVID-19 impact on the growth of the CRISPR and CAS Gene Market

Successful market entry strategies formulated by emerging market players

Pricing and marketing strategies adopted by established market players

Country-wise assessment of the CRISPR and CAS Gene Market in key regions

Year-on-Year growth of each market segment over the forecast period 2026

The CRISPR and CAS Gene Market report considers the following years to predict market growth:

Historic Year: 2014 2018

Base Year: 2019

Estimated Year: 2020

Forecast Year: 2020 2027

The Global CRISPR and CAS Gene Market is displayed in 13 Chapters:

Chapter 1: Market Overview, Drivers, Restraints and Opportunities

Chapter 2: Market Competition by Manufacturers

Chapter 3: Production by Regions

Chapter 4: Consumption by Regions

Chapter 5: Production, By Types, Revenue and Market share by Types

Chapter 6: Consumption, By Applications, Market share (%) and Growth Rate by Applications

Chapter 7: Complete profiling and analysis of Manufacturers

Chapter 8: Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expenses

Chapter 9: Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10: Marketing Strategy Analysis, Distributors/Traders

Chapter 11: Market Effect Factors Analysis

Chapter 12: Market Forecast

Chapter 13: CRISPR and CAS Gene Research Findings and Conclusion, Appendix, methodology and data source

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CRISPR and CAS Gene Market Growth Analysis with Top Players Caribou Biosciences Inc., CRISPR Therapeutics, Mirus Bio LLC, Editas Medicine, Takara Bio...

Final Report will add the analysis of the impact of COVID-19 on this industry.

Global Crispr And Crispr-Associated (Cas) Genes Market Research Report 2020-2025 is a historical overview and in-depth study on the current & future market of the Crispr And Crispr-Associated (Cas) Genes industry. The report represents a basic overview of the Crispr And Crispr-Associated (Cas) Genes market share, competitor segment with a basic introduction of key vendors, top regions, product types, and end industries. This report gives a historical overview of the Crispr And Crispr-Associated (Cas) Genes market trends, growth, revenue, capacity, cost structure, and key drivers analysis.

Get a Sample PDF of report @ https://www.industryresearch.biz/enquiry/request-sample/16203415

In Chapter 2.4 of the report, we share our perspectives for the impact of COVID-19 from the long and short term.In chapter 3.4, we provide the influence of the crisis on the industry chain, especially for marketing channels.In chapters 8-13, we update the timely industry economic revitalization plan of the country-wise government.

The report mainly studies the Crispr And Crispr-Associated (Cas) Genes market size, recent trends and development status, as well as investment opportunities, market dynamics (such as driving factors, restraining factors), and industry news (like mergers, acquisitions, and investments). Technological innovation and advancement will further optimize the performance of the product, making it more widely used in downstream applications. Moreover, Porters Five Forces Analysis (potential entrants, suppliers, substitutes, buyers, industry competitors) provides crucial information for knowing the Crispr And Crispr-Associated (Cas) Genes market.

TO UNDERSTAND HOW COVID-19 IMPACT IS COVERED IN THIS REPORT

Key players in the global Crispr And Crispr-Associated (Cas) Genes market covered in Chapter 5:

Global Crispr And Crispr-Associated (Cas) Genes Industry 2020 Market Research Report also provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

Top Countries Data Covered in Crispr And Crispr-Associated (Cas) Genes Market Report are United States, Canada, Mexico, Germany, UK, France, Italy, Spain, Russia, China, Japan, South Korea, Australia, India, Southeast Asia, Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Brazil, Argentina, Columbia, Chile, and Others

Scope of the Crispr And Crispr-Associated (Cas) Genes Market Report:

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Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2025) of the following regions are covered in Chapter 8-13:

In Chapter 6, on the basis of types, the Crispr And Crispr-Associated (Cas) Genes market from 2015 to 2025 is primarily split into:

In Chapter 7, on the basis of applications, the Crispr And Crispr-Associated (Cas) Genes market from 2015 to 2025 covers:

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Global Crispr And Crispr-Associated (Cas) Genes Market providing information such as company profiles, product picture and specification, capacity, production, price, cost, revenue and contact information. Upstream raw materials and equipment and downstream demand analysis are also carried out. The Global Crispr And Crispr-Associated (Cas) Genes market development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.

Some of the key questions answered in this report:

With tables and figures helping analyze worldwide Global Crispr And Crispr-Associated (Cas) Genes market growth factors, this research provides key statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

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Years considered for this report:

Key Points from TOC:

1 Market Overview1.1 Product Definition and Market Characteristics1.2 Global Crispr And Crispr-Associated (Cas) Genes Market Size1.3 Market Segmentation1.4 Global Macroeconomic Analysis1.5 SWOT Analysis

2. Market Dynamics2.1 Market Drivers2.2 Market Constraints and Challenges2.3 Emerging Market Trends2.4 Impact of COVID-192.4.1 Short-term Impact2.4.2 Long-term Impact

3 Associated Industry Assessment3.1 Supply Chain Analysis3.2 Industry Active Participants3.2.1 Suppliers of Raw Materials3.2.2 Key Distributors/Retailers3.3 Alternative Analysis3.4 The Impact of Covid-19 From the Perspective of Industry Chain

4 Market Competitive Landscape4.1 Industry Leading Players4.2 Industry News4.2.1 Key Product Launch News4.2.2 M&A and Expansion Plans

5 Analysis of Leading Companies5.1 Company 15.1.1 Company 1 Company Profile5.1.2 Company 1 Business Overview5.1.3 Company 1 Crispr And Crispr-Associated (Cas) Genes Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.1.4 Company 1 Crispr And Crispr-Associated (Cas) Genes Products Introduction

5.2 Company 25.2.1 Company 2 Company Profile5.2.2 Company 2 Business Overview5.2.3 Company 2 Crispr And Crispr-Associated (Cas) Genes Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.2.4 Company 2 Crispr And Crispr-Associated (Cas) Genes Products Introduction

5.3 Company 35.3.1 Company 3 Company Profile5.3.2 Company 3 Business Overview5.3.3 Company 3 Crispr And Crispr-Associated (Cas) Genes Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.3.4 Company 3 Crispr And Crispr-Associated (Cas) Genes Products Introduction

5.4 Company 45.4.1 Company 4 Company Profile5.4.2 Company 4 Business Overview5.4.3 Company 4 Crispr And Crispr-Associated (Cas) Genes Sales, Revenue, Average Selling Price and Gross Margin (2015-2020)5.4.4 Company 4 Crispr And Crispr-Associated (Cas) Genes Products Introduction

6 Market Analysis and Forecast, By Product Types6.1 Global Crispr And Crispr-Associated (Cas) Genes Sales, Revenue and Market Share by Types (2015-2020)6.2 Global Crispr And Crispr-Associated (Cas) Genes Market Forecast by Types (2020-2025)6.3 Global Crispr And Crispr-Associated (Cas) Genes Sales, Price and Growth Rate by Types (2015-2020)6.4 Global Crispr And Crispr-Associated (Cas) Genes Market Revenue and Sales Forecast, by Types (2020-2025)

7 Market Analysis and Forecast, By Applications7.1 Global Crispr And Crispr-Associated (Cas) Genes Sales, Revenue and Market Share by Applications (2015-2020)7.2 Global Crispr And Crispr-Associated (Cas) Genes Market Forecast by Applications (2020-2025)7.3 Global Revenue, Sales and Growth Rate by Applications (2015-2020)7.4 Global Crispr And Crispr-Associated (Cas) Genes Market Revenue and Sales Forecast, by Applications (2020-2025)

8 Market Analysis and Forecast, By Regions8.1 Global Crispr And Crispr-Associated (Cas) Genes Sales by Regions (2015-2020)8.2 Global Crispr And Crispr-Associated (Cas) Genes Market Revenue by Regions (2015-2020)8.3 Global Crispr And Crispr-Associated (Cas) Genes Market Forecast by Regions (2020-2025)Continued.

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Crispr And Crispr-Associated (Cas) Genes Market Size 2020 Explosive Factors of Revenue By Industry Statistics, Progression Status, Emerging Demands,...

The Global CRISPR Market research report presentation is a decisive gateway into unfurling various significant events and developments prevalent in the market spectrum that collectively usher into a flourishing growth outlook in the global CRISPR market. Optimum research hint that the aforementioned market is likely to register a robust growth, reaching over xx million USD through the forecast span, 2020-26, maintaining a steady CAGR valuation of xx% throughout.

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According to meticulous primary and secondary research endeavors on the part of our in-house research experts, the global CRISPR market is likely to emerge from the catastrophic after-effects of the unprecedented COVID-19 pandemic that has severely crippled businesses and paralyzed industries globally. However, post dedicated research initiatives, research suggests an optimistic comeback, suggesting healthy growth at the end of 2026.

Key Manufacturers Analysis:

Intellia Therapeutics, Inc.Transposagen Biopharmaceuticals, Inc.GenScript Biotech CorporationThermo Fisher Scientific, Inc.GE Healthcare Dharmacon IncIntegrated DNA Technologies, Inc.CRISPR TherapeuticsAddgene

The report segregates the market into various segments such as type and application that continue to remain prominent growth influencers in global CRISPR market. To evoke resilient market specific growth factors that constantly shape growth prospects in global CRISPR market, this ardent research report sheds light on market segmentation based on which this research presentation aims to equip report readers with versatile understanding about potential market segments that encourage sustainable revenue generation despite stringent competition.

CRISPR Market Analysis by Types:

Design ToolsPlasmid and VectorCas9 and g-RNADelivery System Products

CRISPR Market Analysis by Applications:

Genome EditingGenetic EngineeringGMO and CropsHuman Stem CellsOthers

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Global CRISPR Market: Regional Review

1. The report is designed to adequately highlight a detailed matrix of region-wise and country-specific classification, depicting volume specific production details as well as refers to consumption patterns, further proceeding with minute details related to revenue generation and growth progress throughout the growth tenure, 2020-26.2. Additionally, in the report on global CRISPR market, research initiatives have suggested significant developments encompassing significant developments across diverse regions as well as countries that enable successful growth prognosis through the forecast span, 2020-26.3. The report draws specific references of country-specific developments across both emerging and developed economies alike that collectively contribute towards uncompromised and healthy growth trail in the global CRISPR market throughout the forecast span.4. The CRISPR market report is systematically classified into graphs, charts and statistical presentation to mimic steady growth.

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1. This meticulous research documentation endeavors to offer extensive overview of the industry and studies the CRISPR market at a multi-faceted perspective.2. The report in order to uphold real time market status is hovering mainly across important areas such as real time market growth status to encourage accurate market specific decisions.3. The CRISPR report is focusing specifically across a range of key development areas such as dynamic segmentation, cross sectional analysis of the target market.4. This elaborate report also is a ready-to-go market specific document encompassing regional overview, opportunity mapping, and competition analysis.

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Global CRISPR Market 2020 Size, Growth Drivers, SWOT Analysis, 2026 Key Companies Overview- Intellia Therapeutics, Inc., Transposagen...

A2Z Market Research announces the release of the Gene Editing Tools Market research report. The market is predicted to grow at a healthy pace in the coming years. Gene Editing Tools Market 2020 research report presents an analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. The Market report offers remarkable data regarding the industrys growth parameters, the current state of the market in terms of analysis of possible economic situations, and macroeconomic analysis.

Gene Editing is a type of genetic engineering in which DNA is inserted, deleted, modified, or replaced in the genome of a living organism. .This process requires specialized tools to be carried out and is generally undertaken in different labs with the help of engineered nucleases. The global gene-editing tool market is expected to register significant growth in the near future attributed to the rise in the prevalence of cancer and genetic disorders such as sickle cell diseases, Alzheimers disease, and others, for which there are close to none or very limited therapy options available, along with other genetic and metabolic disorders such as diabetes, obesity, and others. Gene Editing Tools Market is growing at a CAGR of +18% during the forecast period 2020-2026.

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The top companies in this report include:

Thermofisher Scientific, CRISPR Therapeutics, Editas Medicine, NHGRI, Intellia Therapeutics, Merck KGaA, and others.

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For a comprehensive analysis, the Gene Editing Tools market is segmented by product type, region, and application. Due to its regional focus, the market is alien to North America, Europe, Asia-Pacific, the Middle East, and Africa as well as Latin America. Major companies are working on distributing their products and services across different regions. In addition, procurements and associations from some of the leading organizations. All of the factors intended to drive the global marketplace are examined in depth.

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This report gives an in-depth and broad understanding of the Gene Editing Tools Market. With exact data cover all key features of the current market, this report offers widespread data from leading companies. Appreciative of the market state by amenability of correct historical data regarding each and every sector for the forecast period is mentioned. Driving forces, restraints, and opportunities are given to help give an improved picture of this market investment for the forecast period of 2020 to 2027.

Key Factors Impacting Market Growth:

o Convergence of data with accuracy and high speedo Rising demand for efficient computingo Increasing opportunities through improved research, computation, and data analysis performanceso High price and data security issues

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Gene Editing Tools Market to Witness a Pronounce Growth During 2020-2027 | Top Manufacturers: Thermofisher Scientific, CRISPR Therapeutics, Editas...

CRISPR Technology Industry 2020 Market Research Report A new report added by DeepResearchReports.com to its research database. CRISPR Technology Market is segmented by Regions/Countries. All the key market aspects that influence the CRISPR Technology market currently and will have an impact on it have been assessed and propounded in the CRISPR Technology market research status and development trends reviewed in the new report.

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The economical unrest across the globe due to Covid19 pandemic has affected different industries. Several businesses have gone through revenue hassles. It has impacted many product launches and marketing strategies to an extent that numerous industries and global businesses were compelled to either cease, halt or even shut their operations. Now, when businesses are trying to refurbish their existence across the globe, a ready referral guide in the form of market research report can help in providing a direction with the useful information about the market dynamics.

Next, learn how to build the strategy and business case to implement. Learn about CRISPR Technology market and how it can provide value to your business. In this market, you will find the competitive scenario of the major market players focusing on their sales revenue, customer demands, company profile, import/export scenario, business strategies that will help the emerging market segments in making major business decisions. This report also studies the global market competition landscape, market drivers and trends, opportunities and challenges, risks and entry barriers, sales channels, distributors and Porters Five Forces Analysis.

About the report:

The new tactics of CRISPR Technology market report offers a comprehensive market breakdown on the basis of value, volume, CAGR, and Y-o-Y growth. For business robust expansion, the report suggests new tools and technology development will drive to boom in the near future by 2026. The CRISPR Technology market report provides a comprehensive outline of Invention, Industry Requirement, technology and production analysis considering major factors such as revenue, investments and business growth.

This report for CRISPR Technology Market discovers diverse topics such as regional market scope, product-market various applications, market size according to a specific product, CRISPR Technology sales and revenue by region, manufacturing cost analysis, industrial chain, market effect factors Analysis, and more.

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Table of Contents

Chapter 1 CRISPR Technology Market OverviewChapter 2 Global CRISPR Technology Competition by Players/Suppliers, Type and ApplicationChapter 3 United States CRISPR Technology (Volume, Value and Sales Price)Chapter 4 China CRISPR Technology (Volume, Value and Sales Price)Chapter 5- Europe CRISPR Technology (Volume, Value and Sales Price)Chapter 6 Japan CRISPR Technology (Volume, Value and Sales Price)Chapter 7 Southeast Asia CRISPR Technology (Volume, Value and Sales Price)Chapter 8 India CRISPR Technology (Volume, Value and Sales Price)Chapter 9 Global CRISPR Technology Players/Suppliers Profiles and Sales DataChapter 10 CRISPR Technology Manufacturing Cost AnalysisChapter 11 Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 12 Marketing Strategy Analysis, Distributors/TradersChapter 13 Market Effect Factors AnalysisChapter 14 Global CRISPR Technology Market Forecast (2020-2026)Chapter 15 Research Findings and ConclusionChapter 16 Appendix

Key Questions Answered in this Report:

What is the market size of the CRISPR Technologyindustry?This report covers the historical market size of the industry (2013-2019), and forecasts for 2020 and the next 5 years. Market size includes the total revenues of companies.

What is the outlook for the CRISPR Technologyindustry?This report has over a dozen market forecasts (2020 and the next 5 years) on the industry, including total sales, a number of companies, attractive investment opportunities, operating expenses, and others.

What industry analysis/data exists for the CRISPR Technologyindustry?This report covers key segments and sub-segments, key drivers, restraints, opportunities, and challenges in the market and how they are expected to impact the CRISPR Technologyindustry. Take a look at the table of contents below to see the scope of analysis and data on the industry.

How many companies are in the CRISPR Technologyindustry?This report analyzes the historical and forecasted number of companies, locations in the industry, and breaks them down by company size over time. The report also provides company rank against its competitors with respect to revenue, profit comparison, operational efficiency, cost competitiveness, and market capitalization.

What are the financial metrics for the industry?This report covers many financial metrics for the industry including profitability, Market value- chain, and key trends impacting every node with reference to the companys growth, revenue, return on sales, etc.

What are the most important benchmarks for the CRISPR Technologyindustry?Some of the most important benchmarks for the industry include sales growth, productivity (revenue), operating expense breakdown, span of control, organizational make-up. All of which youll find in this market report.

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Covid-19 Impact on CRISPR Technology Market to Witness Huge Growth by 2026: Future Development and Top Manufacturers Analysis - Verdant News

Key Developments in the Market:

In March 2018, Kaneka Corporation announced that they have acquired a patent in the Japan for the creation of the method to mass-culture pluripotent stem cells including iPS cells and ES cells. This will help the company to use the technology to produce high quality pluripotent stem cells which can be used in the drug and cell therapy.

In March 2015, Fujifilm announced that they have acquired Cellular Dynamics International. The main aim of the acquisition is to expand their business in the iPS cell-based drug discovery support service with the use of CDS technology. It will help them to product high- quality automatic human cells with the help of the induced pluripotent stem cells. This will help the company to be more competitive in the drug discovery and regenerative medicine.

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Global Induced Pluripotent Stem Cells (iPSCs) Market Scope and Market Size

Induced pluripotent stem cells (iPSCs) market is segmented of the basis of derived cell type, application and end- user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Global Induced Pluripotent Stem Cells (iPSCs) Market Drivers:

Increasing R&D investment activities is expected to create new opportunity for the market.

Increasing demand for personalized regenerative cell therapies among medical researchers & healthcare is expected to enhance the market growth. Some of the other factors such as increasing cases of chronic diseases, growing awareness among patient, rising funding by government & private sectors and rising number ofclinical trialsis expected to drive the induced pluripotent stem cells (iPSCs) market in the forecast period of 2020 to 2027.

High cost of the induced pluripotent stem cells (iPSCs) and increasing ethical issues & lengthy processes is expected to hamper the market growth in the mentioned forecast period.

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Global Induced Pluripotent Stem Cells (iPSCs) Market 2020 Manufacturer Analysis, Technology Advancements, Industry Scope and Forecast to 2027||Fate...

Its uncontroversial among biologists that many species have two, distinct biological sexes. Theyre distinguished by the way that they package their DNA into gametes, the sex cells that merge to make a new organism. Males produce small gametes, and females produce large gametes. Male and female gametes are very different in structure, as well as in size. This is familiar from human sperm and eggs, and the same is true in worms, flies, fish, molluscs, trees, grasses and so forth.

Different species, though, manifest the two sexes in different ways. The nematode worm Caenorhabditis elegans, a common laboratory organism, has two forms not male and female, but male and hermaphrodite. Hermaphroditic individuals are male as larvae, when they make and store sperm. Later they become female, losing the ability to make sperm but acquiring the ability to make eggs, which they can fertilise with the stored sperm.

This biological definition of sex has been swept up into debates over the status of transgender people in society. Some philosophers and gender theorists define a woman as a biologically female human being. Others strongly disagree. Im addressing those who reject the very idea that there are two biological sexes. Instead, they argue, there are many biological sexes, or a continuum of biological sexes.

Theres no need to reject how biologists define the sexes to defend the view that trans women are women. When we look across the diversity of life, sex takes stranger forms than anyone has dreamt of for humans. The biological definition of sex takes all this in its stride. It does so despite the fact that there are no more than two biological sexes in any species youre likely to have heard of. To many people, that might seem to have conservative implications, or to fly in the face of the diversity we see in actual human beings. I will make clear why it does not.

I call this the biological definition of sex because its the one biologists use when studying sex that is, the process by which organisms use their DNA to make offspring. Many philosophers and gender theorists will protest at making the creation of offspring foundational to how we define sex or distinguish different sexes. Theyre surely right that sex as a social phenomenon is much richer than that. But the use of DNA to make offspring is a central topic in biology, and understanding and explaining the diversity of reproductive systems is an important scientific task. Gender theorists are understandably worried about how the biology of sex will be applied or misapplied to humans. What they might not appreciate is why biologists use this definition when classifying the mind-stretching forms of reproduction observed in limpets, worms, fish, lizards, voles and other organisms and they might not understand the difficulties that arise if you try to use another definition.

Many people assume that if there are only two sexes, that means everyone must fall into one of them. But the biological definition of sex doesnt imply that at all. As well as simultaneous hermaphrodites, which are both male and female, sequential hermaphrodites are first one sex and then the other. There are also individual organisms that are neither male nor female. The biological definition of sex is not based on an essential quality that every organism is born with, but on two distinct strategies that organisms use to propagate their genes. They are not born with the ability to use these strategies they acquire that ability as they grow up, a process which produces endless variation between individuals. The biology of sex tries to classify and explain these many systems for combining DNA to make new organisms. That can be done without assigning every individual to a sex, and we will see that trying to do so quickly leads to asking questions that have no biological meaning.

While the biological definition of sex is needed to understand the diversity of life, that doesnt mean its the best definition for ensuring fair competition in sport or adequate access to healthcare. We cant expect sporting codes, medical systems and family law to adopt a definition simply because biologists find it useful. Conversely, most institutional definitions of sex break down immediately in biology, because other species contradict human assumptions about sex. The United States National Institutes of Health (NIH) uses a chromosomal definition of sex XY for males and XX for females. Many reptiles, such as the terrifying saltwater crocodiles of northern Australia, dont have any sex chromosomes, but a male saltie has no trouble telling if the crocodile that has entered his territory is a male. Even among mammals, at least five species are known that dont have male sex chromosomes, but they develop into males just fine. Gender theorists have extensively criticised the chromosomal definition of human sexes. But however well or badly that definition works for humans, its an abject failure when you look at sex across the diversity of life.

The same is true of phenotypic sex, the familiar idea that sex is defined by the typical physical characteristics (phenotypes) of males and females. Obviously, this approach will produce completely different definitions of male and female for humans, for worms, for trees and so forth. Incubating eggs inside your body, for example, is a female characteristic in humans but a male one in seahorses. That doesnt mean that human institutions cant use the phenotypic definition. But it isnt useful when studying the common patterns in the genetics, evolution and so forth of female humans, female seahorses and female worms.

Understanding the complex ways in which chromosomes and phenotypes relate to biological sex will make clear why the biological definition of sex shouldnt be the battleground for philosophers and gender theorists who disagree about the definition of woman. There might be very good reasons not to define woman in this way, but not because the definition itself is poor biology.

Why did sexes evolve in the first place? Biologists define sex as a step towards answering this question. Not all species have biological sexes, and biology seeks to explain why some do and others dont. The fact that no species has evolved more than two biological sexes is also a puzzle. It would be quite straightforward to engineer a species that has three, but none has evolved naturally.

Many species reproduce asexually, with each individual using its own DNA to create offspring. But other species, including our own, combine DNA from more than one organism. Thats sexual reproduction, where two sex cells gametes merge to make a new individual. In some species, these two gametes are identical; many species of yeast, for example, make new individuals from two, identical gametes. They reproduce sexually, but they have no sexes, or, if you prefer, they have only one sex. But in species that make two different kinds of gamete and where one gamete of each kind is needed to make a new organism there are two sexes. Each sex makes one of the two kinds of gamete.

In complex multicellular organisms, such as plants and animals, these two kinds of gamete are very different. One is a large, complex cell, what wed typically call an egg. Its similar to the eggs produced by asexual species, which can develop into a new organism all on their own. Many species of insect and some lizards, snakes and sharks can reproduce using just an egg cell. The other kind of gamete is a much smaller cell that contains very little beyond some DNA and some machinery to get that DNA to the larger gamete. We are familiar with these two kinds of gametes from human eggs and sperm.

Theres no obvious reason why complex multicellular organisms need to have two kinds of gamete, or why these two kinds are so different in size and structure. Its perfectly possible to make three or more different kinds of gamete, or gametes that vary continuously, just as people vary continuously in height. One question that biologists seek to answer, then, is why those forms of sexual reproduction arent observed in complex organisms such as animals and plants.

Earthworms are hermaphrodites: one part of the worm produces sperm and another part produces eggs

When a species produces two different kinds of gamete, biologists call this anisogamy, meaning not-equal-gametes. Some anisogamic species have separate sexes, like humans do, where each individual can produce only one kind of gamete. Other anisogamic species are hermaphrodites, where each individual produces both kinds of gamete. Because they produce two kinds of gametes, hermaphroditic species still have two biological sexes they simply combine them in one organism. When a biologist tells you that earthworms are hermaphrodites, they mean that one part of the worm produces sperm and another part produces eggs.

Some single-celled and very simple multicellular organisms have evolved something called mating types. These are gametes that are identical in size and structure, but in which the genome of each gamete contains genetic markers that affect which other gametes it can combine with. Typically, gametes with the same genetic marker cant recombine with one another. Some species have many hundreds of these mating types, and newspapers often report research into this phenomenon under headlines such as: Scientists discover species with hundreds of sexes! But, formally, biologists refer to these as mating types, and reserve the term sexes for gametes that are different in size and structure.

Why distinguish between these two phenomena? One reason is that the evolution of anisogamy gametes that differ in size and structure explains the later evolution of sex chromosomes, sex-associated physical characteristics and much more. But the existence of mating types doesnt have these dramatic knock-on evolutionary effects. Another reason to keep the distinction is that anisogamy and mating types are thought to have evolved via different evolutionary processes. One theory is that anisogamy appeared when mating-type genome markers somehow became linked to genes that controlled the size of the gamete, or mutated in some way that affected gamete size. These differences in gamete size would then kickstart the evolution of sexes.

The evolution of sex seems to be strongly associated with multicellularity, so the obvious place to look for a shift from mating types to sexes is in organisms that sit at the multicellular boundary such as algae, which sometimes exist as single-celled organisms, and sometimes as colonies of cells. And indeed, there are species of algae where gametes are just a little bit anisogamous, blurring the distinction between mating types and sexes. Theres much we dont know about how sex evolved, and how it might have evolved differently across species. But the point is that sexes and mating types are very different phenomena, with different causes and consequences.

The fact that sex evolved in some species but not others tells us something important about how biologists think about sex. Many cultures take the difference between male and female to be something fundamental, and label other natural phenomena such as the Sun and the Moon as male or female. But for biologists, the separation between male and female is no more fundamental or universal than photosynthesis or being warm-blooded. Some species have evolved these things, and some havent. They exist when they do only because of the local advantages they afforded in evolutionary competition.

So why did some species evolve two, distinct sexes? To answer this question, we need to forget about creatures with complex sex organs and mating behaviours. These evolved later. Instead, think of an organism that releases its gametes into the sea, such as coral, or into the air, such as fungal spores. Next, consider that there are two goals that any gamete must achieve if its to reproduce sexually. The first is finding and recombining with another gamete. The second is producing a new individual with enough resources to survive. One widely accepted idea, then, is that the evolution of sexes reflects a trade-off between these goals. Because no organism has infinite resources, organisms can either produce many small gametes, making it more likely that some of them will find a partner, or produce fewer but larger gametes, making it more likely that the resulting individual will have what it needs to survive and thrive.

Since the 1970s, this idea has been used to model how anisogamic species might have evolved from species with only one kind of gamete. As mutations introduce differences in gamete size, two winning strategies emerge. One is to produce a large number of small gametes too small to create viable offspring unless they recombine with a larger, well-provisioned gamete. The other winning strategy is to produce a few, large, well-resourced gametes that can create viable offspring, no matter how small the recombinant they end up merging with. Intermediate approaches, such as producing a moderate number of moderately well-provisioned gametes, dont do well. Organisms that try to follow the middle way end up with gametes less likely to find a partner than smaller gametes, and more likely to have insufficient resources than larger gametes. When the two successful complementary strategies have evolved, fresh evolutionary pressures make the gametes even more distinct from one another. For example, it can be advantageous for the small gametes to become more mobile, or for the large, immobile gametes to send signals to the mobile ones.

Once anisogamy has evolved, it shapes many other aspects of reproductive biology. Most species of limpet shellfish that you see on rocks at the beach are sequential hermaphrodites. When young and small they are male, and when mature and large they become female. This is believed to be because small limpets dont have sufficient resources to produce large female gametes, but theyre capable of producing the smaller male ones. In some other species, successful males can arrest their growth and remain small (and male) for their entire life.

Chromosomes arent male or female because these bits of DNA define biological sex. Its the other way around

Sequential hermaphroditism occurs in the opposite direction too. Australian snorkellers love to spot the large blue males of the eastern blue groper, but its rare to see more than one. Most groper are smaller, brown females. They are all born female and become sexually mature after a few years, when 20 or 30 cm in length. At around 50 cm, they change sex and acquire other male characteristics, such as being blue. Unlike the limpet, the main problem facing a male groper is controlling a territory on the reef, so becoming male when youre small is a losing strategy.

Biology aims to understand the extraordinary diversity of ways in which organisms reproduce themselves, as well as to identify common patterns, and to explain why they occur. In general, organisms become sexually mature when they reach an optimal size for reproduction. This optimal size is often different for the two sexes, because the two sexes represent divergent strategies for reproduction. The limpet and the groper are two of many examples. In constructing these explanations, biological sex is defined as the production of one type of viable anisogamous gamete. If we defined sex in some other way, it would be hard to see the common patterns across the diversity of life, and hard to explain them.

So-called sex chromosomes, such as the XX and XY chromosome pairs seen in humans, are often brandished as something thats fundamental to sex. Its partly the inadequacy of this definition that drives scepticism about the existence of two, discrete biological sexes. Molecular genetics is likely to require a shift from binary sex to quantum sex, with a dozen or more genes each conferring a small percentage likelihood of male or female sex that is still further dependent on micro- and macroenvironmental interactions, writes the gender scholar Vernon Rosario.

But any biologist already knows that theres more to sex determination than chromosomes and genes, and that male and female sex chromosomes are neither necessary nor sufficient to make organisms male and female. Several species of mammal, all rodents of one kind or another, have completely lost the male Y chromosome, but these rats and voles all produce perfectly normal, fertile males. Other groups of species, such as crocodiles and many fish, have neither sex chromosomes nor any other genes that determine sex. Yet they still have two, discrete biological sexes. The Australian saltwater crocodile, whom we met before, lays eggs that are very likely to develop into gigantic, highly territorial males if incubated between 30 and 33 degrees Celsius. At other temperatures, genetically identical eggs develop into much smaller females.

The reality is that chromosomes arent called male or female because these bits of DNA define biological sex. Its the other way around in some species that reproduce using two discrete sexes, those sexes are associated with different bits of DNA. But in other species this association is either absent or unreliable. Medical institutions use a chromosomal definition of sex because they judge, rightly or wrongly, that this is a reliable way of categorising humans. But humans really arent the best place to start when trying to understand sex across the diversity of life.

So much for genes. But perhaps sex could be defined by the physical characteristics that organisms develop, which then add up to constitute an organisms sex? An organism with more female than male characteristics would be more female than male and vice-versa. Thats a reasonable way to think about sex, and this idea of phenotypic sex is widely used. But if we apply the biological definition of sex, some of the individuals who are in the middle as far as sex-associated characteristics go are bona fide members of one biological sex. Others are not clearly members of either biological sex.

Nothing in the biological definition of sex requires that every organism be a member of one sex or the other. That might seem surprising, but it follows naturally from defining each sex by the ability to do one thing: to make eggs or to make sperm. Some organisms can do both, while some cant do either. Consider the sex-switching species described above: what sex are they when theyre halfway through switching? What sex are they if something goes wrong, perhaps due to hormone-mimicking chemicals from decaying plastic waste? Once we see the development of sex as a process and one that can be disrupted it is inevitable that there will be many individual organisms that arent clearly of either sex. But that doesnt mean that there are many biological sexes, or that biological sex is a continuum. There remain just two, distinct ways in which organisms contribute genetic material to their offspring.

Whats more, the physical characteristics of an organism can be labelled as male or female only if there is already a definition of sex. Whats so male about a groper being blue as opposed to brown? Many male organisms are brown. Whats so female about incubating eggs in a womb? After all, in many pipefish and seahorse species the male incubates the eggs in his brood pouch. What makes this part of the hermaphroditic earthworm male and that part female? Gender studies scholars have noticed this logical discrepancy, and some have gone on to argue that the sexes must therefore be defined in terms of gender. But from a biological perspective, what makes an observable physical characteristic male or female is not its association with gender, but its association with something more tangible: the production of one or other of the two kinds of gamete.

This explains why the existence of individuals with combinations of male and female characteristics doesnt show that biological sex is a continuum. These organisms have a combination of characteristics associated with one biological sex and characteristics associated with the other biological sex. They do not have some part of the ability to make small gametes combined with some part of the ability to make large gametes. Their phenotypic sex might be intermediate, but their biological sex is not. Being fully biologically male and fully biologically female hermaphroditic can be an effective evolutionary strategy, and we have encountered several hermaphroditic species already. But making both kinds of gametes incompletely would be an evolutionary dead-end.

Like phenotypic characteristics, sex chromosomes can be more or less reliably associated with biological sex. The eastern three-lined skink, an Australian lizard, has sex chromosomes, and under some circumstances XY skinks become male and XX skinks become female, just as in humans. But in cold nests, every skink becomes male, whatever their chromosomes. By becomes male, biologists mean that they grow up to produce small gametes sperm.

No animal is conceived with the ability to make sperm or eggs (or both). This ability has to grow

This effect of temperature on sex is not surprising, as many reptile species produce genetically identical offspring whose sex is determined by incubation temperature. Whats more surprising is that varying the size of the egg yolk in this species of skink can produce both sexes with the wrong sex chromosomes: XX males and XY females. The skink seems to have three mechanisms for determining sex chromosomes, temperature and hormones in the yolk. This is not a mere quirk of nature. The skink is one of many species that actively control the sex of their offspring, responding to environmental cues that predict whether male or female offspring have better chances of surviving and reproducing.

If all species were like the skink, we probably wouldnt label sex chromosomes as male or female. After all, we dont think of extreme nest temperatures as female and intermediate temperatures as male, merely because they produce male and female crocodiles or male and female geckos. We think of sex chromosomes as male or female because we focus on species where they are reliably associated with the production of male or female gametes.

Sex chromosomes play much the same role in sex determination as nest temperatures and hormones. Theyre simply mechanisms that organisms use to turn genes on and off in offspring so that they develop a biological sex. No animal is conceived with the ability to make sperm or eggs (or both). This ability has to grow, through a cascade of interactions between genes and environments. In some species, once an individual acquires a sex, it remains that sex for the rest of its life. In others, individuals can switch sex one or more times. But in every case, the underlying mechanisms are designed to grow organisms that make either male or female gametes (or both). The other changes the body undergoes as it becomes male, female or hermaphroditic are designed to fit the reproductive strategies that this species has evolved.

These mechanisms by which organisms develop or switch biological sex are complex, and many factors can interfere with them. So they produce a lot of phenotypic diversity. Sometimes, organisms grow up able to make fertile gametes, but otherwise atypical for their biological sex. Sometimes, they grow up unable to make fertile gametes of either kind. This is usually an accident, but sometimes by design. In bees, eggs that arent fertilised develop into males, so male bees have half as many chromosomes as female bees. Meanwhile, all fertilised eggs start to develop into females, but most of them never complete their sexual development. The queen sends chemical signals that block the development of the worker bees ovaries at an early stage. So worker bees are female in the extended sense that they would develop into fertile females if they werent actively prevented from doing so. Occasionally, worker bees manage to evade these controls and lay their own eggs. They are not popular with beekeepers, who select against these mutant strains.

The diversity of outcomes in individual sexual development doesnt mean that there are many biological sexes or that biological sex is a continuum. Whatever the merits of those views for chromosomal sex or phenotypic sex, they are not true of biological sex. A good way to grasp this is to imagine a species that really does have three biological sexes. Biotechnologists have proposed curing mitochondrial diseases by removing the nucleus from an egg with healthy mitochondrial DNA, and inserting a new nucleus containing the nuclear DNA from an unhealthy egg and the nuclear DNA from a sperm. The resulting child would have three genetic parents.

Now imagine if there was a whole species like this, where three different kinds of gametes combined to make a new individual a sperm, an egg and a third, mitochondrial gamete. This species would have three biological sexes. Something like this has actually been observed in slime moulds, an amoeba that can, but need not, get its mitochondria from a third parent. The novelist Kurt Vonnegut imagined an even more complex system in Slaughterhouse-Five (1969): There were five sexes on Tralfamadore, each of them performing a step necessary in the creation of a new individual. But the first question a biologist would ask is: why havent these organisms been replaced by mutants that dispense with some of the sexes? Having even two sexes imposes many extra costs the simplest is just finding a mate and these costs increase as the number of sexes required for mating rises. Mutants with fewer sexes would leave more offspring and would rapidly replace the existing Tralfamadorians. Something like this likely explains why two-sex systems predominate on Earth.

We can also imagine a species where biological sex really does form a continuum. Recall that some algae have slightly anisogamous gametes, much closer together than sperm and eggs. We can imagine a more complex organism using this system, with some slightly smaller gametes and some slightly larger ones. Successful reproduction might require two gametes that, when added together, are big enough but not too big. But the sexually reproducing plants and animals that actually exist all have just two, very different kinds of gamete male and female. Theyre not merely different in size, theyre fundamentally different in structure. This is the result of competition between organisms to leave the greatest number of genetic descendants. In complex multicellular organisms such as plants and animals, we know of only three successful reproductive strategies: two biological sexes in different individuals, two biological sexes combined in hermaphroditic individuals, and asexual reproduction. Some species use one of these strategies, some use more than one.

Human beings have come up with many ways to classify the diversity of individual outcomes from human sexual development. People who want to apply the biological definition of sex to humans should recognise that its ill-suited to do what many human institutions want, which is to sort every individual into one category or another. What sex are worker bees? They are sterile workers whose genome was designed by natural selection to terminate ovary development on receipt of a signal from the queen bee. They share much of the biology of fertile female bees but if someone wants to know Are worker bees really female?, theyre asking a question that biology simply cant answer.

Nor is being a sterile worker a third biological sex alongside male and female. This is easier to see in ants, where there is more than one sterile caste. Workers, soldiers, queens and male flying ants each have specialised bodies and behaviour, but there are not four biological sexes of ant. Workers and soldiers are both female in an extended sense, but not in the full-blown sense that queen ants are female. There is a human imperative to give everything a sex, as mentioned above, but biology doesnt share it.

The biological definition of sex wasnt designed to ensure fair sporting competition, or settle healthcare disputes

Juvenile organisms and postmenopausal human females also cant produce either kind of gamete. Juveniles are assigned to the sex they have started to grow into. But once again, this is more complicated than it seems when we focus only on humans. In almost all mammals, sexual differentiation is initiated by a region of the Y chromosome, so a mammalian egg can become either male or female. In birds, its the other way around the egg carries the sex-determining W chromosome, so sperm can become either male or female. After fertilisation, therefore, we can say that an individual mammal or bird has a sex in the sense that it has started to grow the ability to produce either male or female gametes. With a crocodile or a turtle, though, wed have to wait until nest temperature had its sex-determining effect. But that doesnt mean that we need to create a third biological sex for crocodile eggs!

More importantly, nothing guarantees that any of these organisms, including those with sex chromosomes, will continue to grow to the point where they can actually produce male or female gametes. Any number of things can interfere. From a biological point of view, there is nothing mysterious about the fact that organisms have to grow into a biological sex, that it takes them a while to get there, and that some individuals develop in unusual or idiosyncratic ways. This is a problem only if a definition of sex must sort every individual organism into one sex or another. Biology doesnt need to do that.

In human populations, there are plenty of individuals whose sex is hard to determine. Biologists arent blind to this. The definition of biological sex is designed to classify the human reproductive system and all the others in a way that helps us to understand and explain the diversity of life. Its not designed to exhaustively classify every human being, or every living thing. Trying to do so quickly leads to questions that have no biological meaning.

Human societies cant delegate to biology the job of defining sex as a social institution. The biological definition of sex wasnt designed to ensure fair sporting competition, or to settle disputes about access to healthcare. Theorists who want to use the biological definition of sex in those ways need to show that it will do a good job at the Olympics or in Medicare. The fact that its needed in biology isnt good enough. On the other hand, whatever its shortcomings as an institutional definition, the concept of biological sex remains essential to understand the diversity of life. It shouldnt be discarded or distorted because of arguments about its use in law, sport or medicine. That would be a tragic mistake.

The authors research is supported by the Australian Research Council and the John Templeton Foundation. He would also like to thank Nicole Vincent, Jussi Lehtonen, Stefan Gawronski and Joshua Christie for their feedback on earlier drafts.

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Sex is real - aeon.co

Twenty-two research projects led by researchers from the Faculty of Medicine and affiliated health authority research centres were awarded $15 million from the Canadian Institute of Health Research Project Grant Spring 2020 competition.

The Project Grant program supports researchers in building and conducting health-related research and knowledge translation projects, covering all areas of health.

In addition to the Project Grant Spring 2020 competition, one Faculty of Medicine project was awarded a priority announcement bridge grant of $100,000.

Pilot RCT for cognitive-behavioural & mindfulness-based online programs for female sexual dysfunctionUBC Principal Investigator: Dr. Lori Brotto, department of obstetrics & gynaecology

Identification of HOXB13 inhibitors to treat castrate-resistant prostate cancerUBC Principal Investigators: Dr. Martin Gleave, department of urologic sciences, Nathan Lack, department of urologic sciences

Predicting and Evaluating Anal Cancer in HIV with novel biomarkers: The PEACH StudyUBC Principal Investigators: Dr. Jonathan (Troy) Grennan, department of medicine

A randomized trial of doxycycline chemoprophylaxis for the prevention of sexually transmitted infections in gay, bisexual and other men who have sex with men (gbMSM)UBC Principal Investigators: Dr. Jonathan (Troy) Grennan, department of medicine, Mark Hull, department of medicine

Chronic diseases in mothers and risks of neuro-developmental disorders in offspring: an international comparisonUBC Principal Investigator: Dr. K. S. Joseph, School of Population and Public Health

Novel endothelial engineering and localized immunosuppression approaches for the protection of organ transplantsUBC Principal Investigators: Dr. Jayachandran Kizhakkedathu, department of pathology and laboratory medicine

Childhood Epigenetic Age Deviations and Developmental Differences (CEAD3)UBC Principal Investigator: Dr. Michael Kobor, department of medical genetics

Characterization and treatment of a novel conditional mouse model of pyridoxine-dependent epileptic encephalopathy caused by antiquitin mutations.UBC Principal Investigator: Dr. Blair Leavitt, department of medical genetics

Improving clinical practice recommendations for late preterm antenatal corticosteroids: incorporating a decision support tool to tackle the uncertain balance of risks and benefitsUBC Principal Investigator: Dr. Jessica Liauw, department of obstetrics & gynaecology

Enterovirus subversion of the autophagy pathwayUBC Principal Investigator: Dr. Honglin Luo, department of pathology and laboratory medicine

Reducing unsafe prescribing of prescription opioid medications to opioid nave patientsUBC Principal Investigators: Dr. Rita McCracken, department of family practice, Evan Wood, department of medicine

Maternal exposures during pregnancy as drivers of susceptibility to allergic asthma and Th2 inflammation.UBC Principal Investigator: Dr. Kelly McNagny, department of medical genetics

Self-Management for Amputee Rehabilitation using Technology (SMART) program: A peer supported mHealth approach for rehabilitation after lower limb amputationUBC Principal Investigators: Dr. William Miller, department of occupational science and occupational therapy, Maureen Ashe, department of family practice, William Mortenson, department of occupational science and occupational therapy, Michael Payne, medical microbiology

Evaluating tetrahydrocannabinol as an adjunct to opioid agonist therapy for individuals living with opioid use disorder: A Phase II, placebo-controlled, blinded, pilot study to assess safety and feasibilityUBC Principal Investigator: Dr. Michael-John Milloy, department of medicine

Engaging and retaining marginalized populations in primary health care in the downtown east side of VancouverUBC Principal Investigator: Dr. David Moore, department of medicine

Improved Assessment of Disease in Lymphoma Patients using Quantitative PET ImagingUBC Principal Investigator: Dr. Arman Rahmim, department of radiology

Delineating between pathophysiologic phenotypes of hypoxic ischemic brain injury after cardiac arrestUBC Principal Investigator: Dr. Mypinder Sekhon, department of medicine

Tissue resident and migratory group 2 innate lymphoid cells in health and diseaseUBC Principal Investigator: Dr. Fumio Takei, department of pathology & laboratory medicine

Neuro-cardiac predictors of treatment response to rTMS in depression: a mechanistic study using interleaved TMS-fMRIUBC Principal Investigator: Dr. Fidel Vila-Rodriguez, department of psychiatry

Low frequency repetitive transcranial magnetic stimulation (TMS) vs. intermittent Theta Burst Stimulation TMS effectiveness in depression and suicidal ideation: a randomized non-inferiority trialUBC Principal Investigator: Dr. Fidel Vila-Rodriguez, department of psychiatry

The role of PRDM16 in neuroendocrine prostate cancer development and aggressivenessUBC Principal Investigator: Dr. Yuzhuo Wang, department of urologic sciences

A prospective and longitudinal investigation of concussive and subconcussive mild traumatic brain injury mechanisms in ice hockeyUBC Principal Investigators: Dr. Alexander Rauscher, department of pediatrics, Lyndia (Chun) Wu, Faculty of Applied Science, Paul van Donkelaar, Faculty of Health and Social Development

Understanding Human Primary Atopic Disorders (Priority Announcement:Skin Conditions)UBC Principal Investigators: Dr. Stuart Turvey, department of pediatrics, Catherine Biggs, department of pediatrics

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Faculty of Medicine researchers receive $15M from CIHR's Project Grant program - UBC Faculty of Medicine