Archive for October, 2020

ALDERSON, W.Va. (WVVA) A Greenbrier County teen is about to become one of the first five patients in history to receive an experimental gene therapy for Hurler's Syndrome.

The Alderson native is in many ways your typical 13-year-old. "I like to help my dad feed cows....and donkeys," said Kendra Goins.

But life hasn't always been easy for Kendra. The extremely rare condition makes it impossible for her body to breakdown certain sugars. In addition to causing damage to her organs, the condition makes it difficult for her body to grow.

But whenever anyone has anything to say about it, her sister, Kiristen is always the first time stand up.

"Me with my big head is always the one to jump in," said Goins, who said she has gotten into quite a few quarrels over the issue at school in defense of her sister.

She worries though that she won't be able to jump in when Kendra heads to California soon for a clinical trial. Kendra is heading into the treatment with her first bone marrow transplant nearing the end of its course.

"I've spoken with experts across the country from the chemists who made the drug to the doctor who has used it. This looks like her golden ticket," said Kendra's mother Sheryl Goins.

Administered through the brain, the goal of the gene therapy is to help her body produce the enzymes she needs to survive.

While the cost of the clinical trial and airfare is covered, the family said they need help with expenses they will incur during their three-month stay.

To learn more about how you can help, visit https://www.gofundme.com/f/kendra039s-gene-therapy?utm_source=facebook&utm_medium=social&utm_campaign=p_cp%20share-sheet&fbclid=IwAR3yzHCexch5a_awjaYy06ijB28zMXJ-72WkfQ-SPEwMQgy5s8x_carlz34

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Greenbrier County teen to be among first in nation to receive gene therapy for Hurler's Syndrome - WVVA TV

Regenxbio announces expansion of RGX-121 clinical program

Regenxbio Inc. (RGNX) announced the expansion of its Mucopolysaccharidosis Type II clinical program. The company stated that the expansion will allow it to gain additional understanding of the neurodegenerative aspects of the disease. The expansion will also let Regenxbio in a broader patients population.

The Phase I/II study seeks to examine a single intracisternal administration of RGX-121 in patients under the age of 5 years. All these patients have severe MPS II. The company has already dosed six patients across two dose levels. The main aim of the study is to assess the safety and tolerability of RGX-121 and to evaluate the impact of the drug candidate on biomarkers of I2S enzyme activity, neurocognitive development and other clinical measures.

Regenxbio intends to start expanded enrollment of patients in Cohort 2 immediately. The decision has been taken based on the basis of recommendations made by the Independent Data Monitoring Committee and MPS II treating physicians. Steve Pakola, M.D., Chief Medical Officer of Regenxbio said, Regenxbio is committed to advancing potential gene therapy treatment options for MPS II, as there remains a significant unmet medical need to address the neurological manifestations and prevent or stabilize cognitive decline for patients.

As of September 16, 2020, RGX-121 was found to be well-tolerated in all six patients. No drug-related serious adverse events were reported. The company now plans to dose up to six additional patients with a second dose level of 6.5x1010 genome copies per gram (GC/g) of brain mass. Regenxbio expects to provide further updates from the study by the end of 2020.

Regenxbio also reported that the FDA has cleared its Investigational New Drug Application. The company plans to start the second Phase I/II trial of the drug candidate for treating pediatric patients with severe MPS II ages 5-18 years old. This multicenter, open-label trial will enroll up to six patients and the drug candidate will be administered directly to the cerebrospinal fluid through intracisternal or intracerebroventricular injection.

Regenxbio plans to open a new observational natural history trial for enrollment in the second half of 2020. This trial will study the neurocognitive development and key biomarkers in patients with severe MPS II. The trial will prospectively record the changes in neurodevelopmental issues of cognitive, behavioral and adaptive function over a period of time. It will also evaluate biomarker activity in serum, urine and the CSF. The trial will enroll up to 40 patients between the ages of 1 month and 8 years with genetic diagnosis of severe MPS II. The assessment will be carried out for up to two years.

RGX-121 is being developed for treating Mucopolysaccharidosis Type II. It aims to work by using the AAV9 vector for delivering the human iduronate-2-sulfatase gene which is responsible for encoding the iduronate-2-sulfatase (I2S) enzyme to the central nervous system. RGX-121 has been granted orphan drug product, rare pediatric disease and Fast Track designations by the FDA.

Investment Thesis: Regenxbio had a tumultuous past year and the stock has lost nearly 50 percent of its Pre-Covid valuation. While the latest news is encouraging, it may be a little too early to gauge the companys prospects ahead.

AbbVie Inc. (ABBV) announced that it has taken a voluntary decision so pull Fibristal from the Canadian market. The decision has been taken after the news of certain patients in Europe contracting rare cases of liver injury and requiring transplantation. AbbVie integrated Allergan's business to its core in May this year. The drug belongs to Allergan and the company decided that the recall is the best option in the prevailing circumstances.

Fibristal contains Ulipristal acetate as one of its main ingredients. Earlier this year, the European Medicines Agencys Pharmacovigilance Risk Committee (PRAC) had recommended the cancelation of the marketing authorization of products containing ulipristal acetate used for treating symptoms of uterine fibroids.

Fibristal in approved in Canada for treating moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. It is also approved as an intermittent treatment of moderate-to-severe signs and symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.

Health Canada is monitoring the effectiveness of the recall. It has advised the patients who take Fibristal to a) stop treatment and contact their doctor to discuss other treatment options; and b) immediately report to their doctor signs and symptoms of liver injury such as nausea, vomiting, stomach ache, severe tiredness, yellowing of the eyes or skin, or dark urine, which could occur after stopping treatment. Health Canada has also issued directives to healthcare professionals to stop prescribing or dispensing Fibristal and to carry out appropriate liver function monitoring.

Investment Thesis: AbbVie is a blue-chip stock with solid foundation. This negative news is not likely to have any material impact on the stock price as the company maintains its robust long-term outlook.

Ionis Pharmaceuticals Inc. (IONS) announced inking a multi-year collaboration with Genuity Science. The deal pertains to the discovery and development of innovative therapeutics across a range of up to 20 diseases. Ionis is looking to boost its presence in key segments with this collaboration and draw synergies.

Genuity Science focuses on high-quality, whole-genome sequence and deep phenotype data. Ionis plans to combine this approach with its proprietary antisense technology to expedite the drug development process. Brett P. Monia, Ph.D., chief executive officer of Ionis said, "The collaboration with Genuity Science gives us the potential to significantly increase our discovery opportunities and better understand the complexities of human diseases based on genetics."

Under the terms of the agreement, Genuity Science will be entitled to receive a combination of upfront payments and development milestones. It will also be entitled to gain product royalties. Genuity Science is a data sourcing, analytics and insights organization. It collaborates with global pharma companies to catalyze precision health services. It offers a wide range of services including high-quality sequencing and disease-specific data sourcing.

Ionis is mainly active in RNA-targeted drug discovery and development segment. The company has developed the first and only approved treatment for all patients, children and adults with spinal muscular atrophy. Its portfolio also contains the worlds first RNA-targeted therapeutic approved for the treatment of polyneuropathy in adults with hereditary transthyretin amyloidosis. The company uses its antisense technology platform to boost its development pipeline. Its drug candidate Pelacarsen is in Phase 3 for cardio-renal indications. Some of its main development partners are Biogen, AstraZeneca and Novartis.

Investment Thesis: Ionis has a well-diversified development pipeline which is expected to keep its stock price buoyant. However, the price has tumbled quite a bit in the recent past, providing an exciting opportunity to build a portfolio with a long-term horizon.

Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts work to be ahead of the curve.

That means that when the catalyst comes that will make or break a stock, weve positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Regenxbio RGX-121 Clinical Program, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha

Dr. Evelyne Bischof speaking at the 2020 China-Israel Summit on Longevity Medicine

Over the past decade, we witnessed unprecedented advances in the field of biogerontology, and the massive convergence of biotechnology, information technology, AI, and medicine. And now we are witnessing the birth of a new field of longevity medicine, which integrates the latest advances in many of these fields of science and technology. My definition longevity medicine is advanced personalized preventative medicine powered by deep biomarkers of aging and longevity.

And, like in the field of AI for drug discovery, women are at the forefront of this revolution and there were precedents when we had to look for a male physician to make a conference panel more diverse.

One of the physician-scientists who stands out in this area is Dr. Evelyne Yehudit Bischof. I first got a note with a request for more information on one of our research papers from Dr. Bischof on December 30th, 2019 while in Shanghai. A request I almost ignored due to the heavy workload but accidentally I looked at her profile which was highly unusual. In brief, Evelyne is a German medical doctor with an MD from Max Planck Institute for Molecular Biology and Genetics, who interned at Columbia University, and Harvard MGH and Beth Israel Medical Deaconess, attending physician at University Hospital Basel in Switzerland, and associate professor at Shanghai University of Medicine and Health Sciences. She fluently spoke six languages including German, Russian, and Mandarin Chinese, which was quite impressive. The second time we met was at Human Longevity Inc, in San Diego when she was interviewing with one of the most influential entrepreneurs and investors in longevity biotechnology, Dr. Wei-Wu He to join HLI as a longevity physician.

Dr. Evelyne Yehudit Bischof

The longevity industry is rapidly emerging and longevity clinics are being set up in various parts of the world. So I decided to ask Eva a few questions to elucidate this new and emerging industry.

Alex: Eva, we know each other for almost a year and you do not fail to impress with your academic publications, public lectures, and clinical work. You are as close to the longevity physician as it can possibly get. Can you tell us a bit more about yourself and about the work that you are doing on the clinical side and on the research side?

Dr. Evelyne Bischof: Thank you, Alex it is an honor to be so generously introduced by a true innovator, scientist and entrepreneur, as well as a longevity KOL and allow me to revert the compliment. I am a rather globally oriented internal medicine specialist, with training and work experience in Germany, USA, Switzerland and China. For almost a decade now, I have been splitting my time between Shanghai and Basel, creating a path that allowed me to conclude my residency and fellowship, develop translational and clinical research niches and collaborators, as well as to engage actively in academic medical education. While my clinical work was mostly based in a university clinic in Basel in internal, intensive and onco-hematologic medicine wards, my scientific pursuits and academic teaching were mostly based in Shanghai, where I went along the track from a junior lecturer to an associate professor in 2016. My research focused primarily, but not exclusively, on oncology and being an internist at core on geroncology and precision medicine in general internal medicine. Geroncology is a crucial field that investigates the very much interlinked pathways of aging and tumorigenesis, leading to the epidemiological observation that age is the number one risk factor to develop cancer for all.

Both Switzerland and China are innovative hubs with strong medical and bioscientific profile, which allowed me to learn from some of the finest experts worldwide. The frequent travels and splitting my life between continents were not always easy, but - coming from a simple background of non-academic farmer and handcraft family Alongside - I will be forever grateful for all the great people I met and worked with, the abundant cultural nuances and differences I was able to learn and appreciate, the stimulating and constructive exchange and so much more in soft and hard skills, on professional and personal level. with the emergence of AI-based solutions in the clinic and with the rise of longevity medicine, my passion and efforts are now focused on these domains, while I continue my clinical practice in the university hospitals, academic lecturing at two medical schools (currently in Shanghai - due to COVID-19-related travel restrictions) and research/public speaking (globally - thanks to COVID-19-related shift to virtual communication).

Alex: Can you tell us about your perspective on the emerging field of longevity medicine starting from your own definition of the field?

Dr. Evelyne Bischof: With pleasure! My personal definition of longevity medicine is clear: it is precision medicine driven by deep aging biomarkers. Surely, the definition is succinct, but extremely deep. Precision medicine is per se an enormously complex and dynamic field, driven by multimodally mined data and their constant re-evaluation, reannotation and reiteration to provide qualitative and quantitative using AI-algorithm outputs applicable for clinical practice. Longevity medicine is a to say the next generation of precision medicine that evaluates the patient within the reference range for the patients ideal age (usually 20-30) and is looking for ways to reduce the gap between the current parameters and the parameters of maximum physical performance for the ideal age. Deep aging clocks as quantifiable, trackable and accurate biomarkers of aging and an indispensable component of longevity medicine. Without being able to actually measure the biological age and its changes due to interventions, longevity medicine cannot be performed. I strongly believe that this field of medicine will revolutionize healthcare and change the mindset of all the doctors, the policy makers, the stakeholders and above all: the patients. Allow me to add that I consider each of us as a patient we all suffer from aging! I also believe that citing Peter Diamandis in the future, if a physician wont be using A.I. in guiding diagnosis and therapy, it'll be a malpractice". This said, I would love to add that we need more passionate physicians in longevity and this can only be achieved with an appropriate educational setting, which will be inaugurated this month by Deep Longevity and collaborators.

Alex: What do you see as the most promising developments in the field of longevity medicine that can truly push the needle and add a few decades if not more to the healthy youthful life of the individual?

Dr. Evelyne Bischof: Besides of deep aging clocks and AgeMetrics, which I truly without cronyism embrace and would encourage all physicians to implement in their daily practice, I see a big potential in gene therapies, in (natural and designed) gerolytics and senolytics, as well as supplements that will show safe efficacy in combating senescence from the molecular to system level. Studies on AKG, rapamycin and metformin are already fueling this hope. Of course, all interventions will require a prior comprehensive precision health assessment and continuous monitoring. For the latter, the wearables and applications will certainly bring us even faster to an extension of a healthy and productive lifespan.

I am encouraged by the fact that there are two major developments, perpetuated by the racing speed of longevity medicine and geroscience. Number one: doctors are shifting from putting a patient on meds to putting a patient on a personalized longevity protocol that becomes a natural, integral, rewarding part of their lives. Number two: society is realizing that it is not important how old one is, but how one shows his/her own age. Remembering this allows one to make sure he or she does not become a slave of the myths about the elderly, but also to be mindful that even at an early chronological age, one might actually experience silent accelerating aging due to modifiable risk factors or pathomechanisms.

Alex: Without promoting Human Longevity Inc or Health Nucleus 100+, can you tell us what an average person with an average income can do to increase their performance and longevity?

Dr. Evelyne Bischof speaking at the 2020 China-Israel Summit on Longevity Medicine

Dr. Evelyne Bischof: This is a very valid question in fact, when it comes to reasonably boosting performance and creating a good base for longevity, one does not necessarily be wealthy. The components of the magic mixture are the well-known pillars of preventative and functional medicine: exercise, nutrition, supplements, moderation. However, longevity physicians are now able to customize the right proportions of each for a specific person, minding the biovariability, comorbidities, chronological age, but also lifestyle and preferences. In an extreme generalization, I would suggest caloric restriction via intermittent fasting to an overall healthy person, with at least an A-Z vitamin and mineral supplement, 15-30min workout at least 3 times a week, moderation in substance use to the minimum, but with permissible enjoyment, if needed (alcohol and cigarettes), a minimum of 6 hours of sleep without interruption, circadian rhythm (regular times) of sleep and food intake, no meals at night (at least 4 hours before night rest) and very importantly cognitive activities (books, foreign languages, crosswords), preferably rewarding ones so that the psychological wellbeing area is also covered. Everyone is able to use stairs as their gym, to not to eat before sleep, to choose water over other drinks, to laugh aloud to oneself and to learn text parts by heart (because decelerating psychological aging and cognitive decline are crucial aspects of healthy longevity). I recall I was always reading the ingredients and how to use? texts on tubes during shower, so as not to waste the time. My first sentence in Russian was actually the instruction of how to use a shampoo.

Dr. Evelyne Bischof speaking at a conference on aging and longevity

Alex: And if someone has nearly unlimited access to capital, what should they do?

Dr. Evelyne Bischof: I believe, as in any other business or property of this particular population, the individuals should seek good investments and insurance in relation to their health and the health of their significant surrounding (family, friends, workers etc.). The investment should involve as precise diagnostics as possible, that harnesses all cutting edge and untapped potential of the human genome, deep quantitative phenotyping, complete -omics and -ioms (e.g. microbiome, epigenomics, metabolomics, proteomics etc.), advanced imaging with radiogenomic algorithms etc. As it is a dynamic field, constantly evolving and implementing new features and/or better ways of interpretation, such diagnostic comprehensive checkups (or part of them) should be repeated regularly. The insurance part does not relate to a contracted policy, but to a complex entity of lifestyle recommendations and interventions lead by an entrusted longevity physician (basically a physician that can list and pronounce the aforementioned terms), who understands and permanently advances in the field, being able to combine human and artificial intelligence and customize an individual approach of prevention and (if needed) therapy for a specific patient. In addition, the leading physician needs to comprehend and implement the personal challenges and preferences of the patient, such as mostly disturbed wake-sleep rhythm, irregular and unhealthy social meals, acute and chronic stress exposure, irritability or fatigue etc., to create a program that will be realistic, allow the patient to remain compliant and engaged based on his/her educated informed decisions. Simply said: knowing 150 GB of a patients data, a physician of trust should be a good lead towards identification, mitigation and elimination of actionable diseases (years and decades ahead) and risk factors that curb the quantity and quality of life.

Alex: I know maybe 3-4 people like you in the world, who have an MD, are actively engaged in biomedical research, and work with some of the high-profile clients who are spoiled with the most cutting-edge medical care provided by the top medical institutions. And all of them are women. Why do we see such gender imbalance in the field?

Dr. Evelyne Bischof in the clinic

Dr. Evelyne Bischof: Again thank you very much for this encouraging statement, this time speaking on behalf of women in medicine, academia and STEM. As you know, one of my side areas of interest is the study of biological sex differences in various diseases, predominantly cancer, and ultimately also on the sex (biological) and gender (socio-cultural) variables influencing pathomechanisms, diagnostic and therapeutic decisions, resulting differing toxicities, follow up strategies and outcomes (recovery, chronification etc.). It was natural to engage in debates and develop curiosity about the gender distribution in academia in general. Recently, with an ad hoc group of collaborators from Europe, USA and China, we demonstrated in a Lancet Oncology paper that female representation at the podium, meaning as keynote speakers and scientific committees at the largest oncological conferences in China. Our data showed that China is much more inclusive, without an intensive active promotion or directives towards gender quotas. As you know, I am a big fan of this country, but this quantitative study once again showed how impressive this country is and perhaps we found one of the contributing factors for the nations booming leading role in biotech and medicine.

Overall however, there are indeed significant differences in various fields, as well as an overall underrepresentation of females in leadership and podium roles. I am happy to see that in longevity science and medicine, we have dedicated females that can unfold their passions and translate them into viable solutions that do impact the public and individual health. As always, the reasons are multifold, but perhaps the most important one is that in longevity, driven women are emerging in an inclusive environment that embraces non-discriminating and non-stigmatized diversion. In different words: the longevity field seems to embrace inclusion at the same (ultrarapid) pace as STEM and medicine are evolving. The sex and gender differences clearly allow to generate creativity and innovation it is a mutually perpetuating process. Last but not least, it is thanks to committed male mentors and collaborators that actually value D&I (diversity and inclusion) intuitively or knowingly (based on evidence that diverse teams outperform the less diverse one by over 35%). Most male KOLs in longevity, like yourself, promote and underline the importance of D&I. On a final note myself, personally, I have always remained at the unconscious side when facing a person I work with. Accountability, motivation and fairness have proven to be non-gender related in my experience as I have faced many challenges being a (previously young) female, permanent foreigner and on top of that blond. The typical situation at a round dinner table in China with 12 male professors usually ended up with us all laughing at my gambei with water being the only discrepancy from the norm.

Dr. Evelyne Bischof speaking at the 2020 China-Israel Summit on Longevity Medicine

Original post:
Women In Longevity Medicine And The Rise Of The Longevity Physician - Forbes

Timothy Ray Brown, dubbed the Berlin Patient, the first ever to be cured of HIV, died from cancer on September 29.

Brown was cured of HIV in 2007. He was diagnosed in 1995, and about a decade later was diagnosed with leukemia. A physician at the Free University of Berlin used a stem cell transplant from a donor with a rare genetic mutation that provided natural resistance to HIV in hopes of curing both diseases. It took two procedures but was successful, and in 2008 Brown was announced free of both HIV and leukemia.

Two years later he went public with the announcement.

I am living proof that there could be a cure for AIDS, he told Agence France-Presse (AFP) in 2012. Its very wonderful, being cured of HIV.

In 2019, a second HIV patient, Adam Castillejo, underwent a similar procedure. He was dubbed the London Patient. A UK resident diagnosed with HIV in 2003, Castillejo began antiretroviral therapy in 2012. He was later diagnosed with advanced Hodgkins lymphoma. He was treated with a stem cell transplant in 2016 after he received chemotherapy. He then continued to receive antiretroviral therapy for 16 months.

To evaluate whether the HIV-1 infection was actually in remission, he went off the usual antiretroviral therapy. After he had been in remission for 18 months, testing confirmed that his HIV viral load was undetectable.

The donors for both men carried a rare genetic mutation called CCR5-delta 32. This made these patients resistant to HIV. Castillejo is currently living HIV-free.

Brown, 54, was born in the U.S. He was diagnosed with HIV in 1995 while living in Berlin. He developed acute myeloid leukemia in 2007.

The leukemia that eventually led to his HIV cure returned this year, where it metastasized to his brain and spinal cord.

Browns partner, Tim Hoeffgen, posted on Facebook, It is with great sadness that I announce that Timothy passed away surrounded by myself and friends, after a five-month battle with leukemia. Tim committed his lifes work to telling his story about his HIV cure and became an ambassador of hope.

The procedure itself is not routinely used to treat HIV because it is both too risky and aggressive. It is primarily used to treat certain types of cancer. In the case of both Brown and Castillejo, it was the combination of HIV and resultant cancers that are effectively treated with stem cell transplants, that made it feasible. Nonetheless, it gave patients hope that there may someday be a cure.

We owe Timothy and his doctor, Gero Hutter, a great deal of gratitude for opening the door for scientists to explore the concept that a cure for HIV is possible, stated Adeeba Kamarulzaman, president of the International Aids Society (IAS).

Sharon Lewin, director of the Doherty Institute in Melbourne, Australia, noted, Although the cases of Timothy and Adam are not a viable large-scale strategy for a cure, they do represent a critical moment in the search for an HIV cure. Timothy was a champion and advocate for keeping an HIV cure on the political and scientific agenda. It is the hope of the scientific community that one day we can honor his legacy with a safe, cost-effective and widely accessible strategy to achieve HIV remission and cure using gene editing or techniques that boost immune control.

Although largely a treatable disease, HIV/AIDS affects about 37 million people globally, and about 1 million people die from HIV-related causes each year. Treatment typically involves a cocktail of antiretroviral therapy, which HIV patients take their entire lives.

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Timothy Ray Brown, First Patient to Be Cured of HIV, Dies of Leukemia - BioSpace

WINDBER Marlene Singer has been a familiar face in Johnstowns health care and philanthropy circles.

A former chairwoman of the local American Cancer Society Relay for Life event, Singer is founder and coordinator of the Johnstown Walk of Hope fundraiser to support cancer patients.

But even with her background in health care and cancer advocacy, no one had ever suggested Singer look at her own cancer risk until her gynecologist brought it up very recently.

All those years, it has never been discussed, Singer said at Joyce Murtha Breast Care Center in Windber. (Genetic testing) had never been offered before.

After a teleconference session with a genetic counselor in Pittsburgh, Singer had blood drawn and sent in for genetic testing.

I found out my risk is not zero, she said. I have a higher-than-normal long-term risk for breast cancer.

The Joyce Murtha centers genetic counselor, Kim Knapp, said Singers experience is not unusual. Family doctors and gynecologists arent providing information about family risk or suggesting genetic counseling, Knapp said.

It should be one of the first things you do for your patients, Knapp said.

My schedule should be so filled that I have a waiting list.

BRCA1, BRCA2

Genetic testing looks for inherited mutations in cells that increase the risk for cancer. The most well known are mutations of the BRCA1 and BRCA2 genes, named as shorthand for breast cancer.

Everyone has the genes, which normally function as tumor suppressors.

When they are mutated, they arent working, so tumor cells can grow uncontrolled.

The average lifetime risk of breast cancer for women is about 12%. For women who have a BRCA1 or BRCA2 mutation, the breast cancer risk is 50-85% by age 70. Their risk of developing ovarian cancer is increased, up to 40-60% by age 85, with BRCA1.

Both genes are also associated with increased risk for other cancers.

BRCA2 is linked to male breast cancer and pancreatic cancer and melanoma in both men and women, according to the American College of Obstetricians and Gynecologists.

Mutations in at least 10 other genes have been linked to increased risk of breast cancer, and there are more inherited gene mutations associated with other cancers.

Windber offers a genetic screening for a panel of almost 50 different mutations.

The new guidelines expand the pool of patients who are eligible for insurance coverage of the test, Knapp said.

Family history

At Indiana Regional Medical Center, breast surgeon and genetic counselor Dr. Dan Clark works with families to identify risk. Women who come in for routine mammograms are given questionnaires to help determine if they are eligible for counseling.

It is family history and personal health history, Clark said. There are certain childhood cancers that are related to breast cancer as an adult.

No more than 1 in 300 people carry the BRCA1 or BRCA2 mutations.

Those patients have two options to improve their odds: Surgically remove both breasts and the ovaries, or establish an enhanced screening regimen. The enhanced screening includes mammograms and magnetic resonance imaging studies alternating every six months.

While Dr. Lauren Deur at UPMC Altoona is a proponent of genetic counseling and screening, she warns that low genetic risk is not the same as low risk.

Theres a misconception that if you dont have a family history, you dont have to get a screening mammogram, Deur said.

The American Cancer Society estimates 5-10% of all cancers come from inherited gene mutations.

We are making critical coverage of the coronavirus available for free. Please consider subscribing so we can continue to bring you the latest news and information on this developing story.

Randy Griffith is a multimedia reporter for The Tribune-Democrat. He can be reached at 532-5057. Follow him on Twitter@PhotoGriffer57.

Read the original:
Breast Cancer Awareness | Genetic testing urged to help pinpoint risk - TribDem.com

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Point-of-Care Genetic Testing Market is Set to Experience Revolutionary Growth by 2027 - PharmiWeb.com

Michael J. Pishvaian, MD, PhD, discusses the key takeaway from his presentation at the 17th Annual Meeting of the International Society of Gastrointestinal Oncology on the role of genetic testing in patients with pancreatic cancer.

Michael J. Pishvaian, MD, PhD, associate professor, School of Medicine, and director, Gastrointestinal, Developmental Therapeutics and Clinical Research Programs, Johns Hopkins Kimmel Cancer Center, discusses the key takeaway from his presentation at the 17th Annual Meeting of the International Society of Gastrointestinal Oncology on the role of genetic testing in patients with pancreatic cancer.

Pishvaian says the most important takeaway is to test patients, and this is supported by both scientific evidence as well as national recommendations. Both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recommend hemline testing for pathogenic hereditary mutations in 100% of pancreatic cancers, irrespective of their disease stage or other characteristics.

In 2019, the NCCN updated their recommendations to introduce somatic testing for patients with advanced pancreatic cancer. This accounts for roughly 80% of pancreatic cancers, says Pishvaian, and these patients, for whom there may be a novel therapy that may provide some degree of benefit, should undergo somatic testing to detect any potential actionable biomarkers.

Link:
Genetic Testing Should Be Considered for All Patients With Pancreatic Cancer - Targeted Oncology

UPDATE: On September 25, 2020, Governor Gavin Newsom vetoed the California Genetic Information Privacy Act (GIPA). Click here for an update.

On August 31, 2020, the California Legislature passed the Genetic Information Privacy Act (GIPA), which regulates the privacy and security aspects of Direct-to-Consumer (DTC) genetic testing and testing companies. If Governor Gavin Newsom signs GIPA into law, it will take effect on January 1, 2021.

A DTC genetic test provides consumers access to their genetic information in a variety of formats without necessarily involving their healthcare providers. The most notable examples of DTC genetic testing companies include 23andMe, Family Tree DNA, and Ancestry.com. A number of DTC genetic testing companies also provide other tailored genetic tests for a diverse range of purposes. Some of these purposes include identifying consumers genetic ancestry, food sensitivities, and predisposition for harmful diseases. Undoubtedly, DTC genetic testing has beneficial applications, but DTC genetic testing also presents data privacy and security risks if left unregulated.

Federal law already regulates genetic tests for safety through the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the Federal Trade Commission. The Genetic Information Nondiscrimination Act also prevents discrimination in hiring or medical care based on a persons genetic proclivities. These laws, however, do not comprehensively regulate the privacy and security concerns of DTC genetic testing, which GIPA aims to address.

GIPA applies to companies that sell, market, interpret, or otherwise offer DTC genetic testing products or services and to companies that analyze genetic data obtained from consumers. GIPA, however, exempts licensed medical providers who are actively diagnosing or treating a patients medical condition.

From a security perspective, GIPA requires DTC genetic testing companies to [i]mplement and maintain reasonable security procedures and practices to protect a consumers genetic data against unauthorized access, destruction, use, modification, or disclosure. Like other data privacy and security laws, GIPA does not specifically state what constitutes reasonable security, and leaves it to individual companies to determine what is reasonable for them based on the industrys best practices.

On the privacy side, GIPA is much more detailed. GIPA requires DTC genetic testing companies to provide notice to consumers regarding their data handling and privacy practices. DTC genetic testing companies must also obtain consumers express consent for collection, use, and disclosure of their genetic data and separate express consent for each use and disclosure of their genetic data. Further, GIPA requires companies to enable users to access and delete their genetic data, and to comply with a consumers request to destroy any genetic samples, subject to some federal provisions for regulatory compliance, within thirty days of the request.

In sum, DTC genetic testing companies should assess gaps in their data privacy and security procedures, and ensure compliance with GIPA. Failure to comply with this law carries stiff penaltiesup to $1,000 penalty for each negligent violation, and intentional violations ranging from $1,000 to $10,000 per incident. If these penalties are aggregated in a class action lawsuit, companies could face significant liability for GIPA violations.

Editor: Arsen Kourinian

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California Passes the Genetic Information Privacy Act | Knobbe Martens - JD Supra

(WXYZ) When Nate Hahn decided to visit his family in Illinois this past July he thought getting a COVID-19 test before would be a smart and safe move.

The 35-year-old went to a metro-Detroit clinic a week before traveling. While the test site indicated that he should get his results within three days enough time to figure out his status before the trip it ended up taking six.

"I didnt get my results by the time I left," said Hahn, "So it sort of defeated the purpose."

The scenario has played out hundreds of times across the state. Even the most fastidious of planners struggle when it comes to timing out a COVID-19 test. But what's causing the delays and uncertainty? According to medical experts, the moving-target comes down to the labs that are being used.

"The more capacity a given lab has, the more samples get sent to that given lab and it overwhelms the lab," said Dr. Phil Levy, who runs a COVID-19 testing site through Wayne Health.

In Michigan, there are over 400 COVID-19 test sites created by medical providers (hospitals, urgent cares, primary cares, pharmacies), as well as some local health departments or local governments. Each site can then contract with a lab of their choosing to process the tests.

These labs, according to Levy, play a major roll in the test-turn around time especially when they're non-local and fielding requests from regions across the country. He uses Wisconsin which is currently seeing a spike in COVID-19 cases as an example.

"Wisconsin all of a sudden its a hotbed," he said, "that then has a collateral impact on all the other locations that are sending tests to those labs as well."

According to Levy many municipalities at the start of the pandemic decided to contract with large, national labs to ensure their tests were processed. But as COVID-19 levels increase in other regions and more people get tested local wait times can get pushed back as well, even if numbers are dwindling in the state.

This scenario played out in the City of Detroit who in March signed a $1.4 million contract with New Jersey-based Bio Reference to help process COVID-19 tests at the State Fairgrounds.

"When we went to Bio Reference there was no one in Michigan that had it and could do it, the testing kits were not there. Thats how we established the relationship," said Hakim Berry, City of Detroit Chief Operating Officer, who helped set up the State Fairgrounds site as a way to help alleviate some of the pressure local hospitals were facing to get testing done.

"During the height of the pandemic, we were shipping out twice a day to New Jersey, sending the samples on dry ice. We were doing up to 1200 a day at its height," Berry continued, adding that at the time results were coming back in three to four days.

But as Michigan's COVID-19 cases began to dip the wait times for COVID-19 tests at the State Fairgrounds began to increase.

"As our numbers went down, everywhere else in the country went up, so thats when our test results started taking seven days, because they were getting slammed by other hot areas," said Berry, who explained that at this point the city began looking for local labs to help ensure that testing at nursing homes could continue without new lag times.

"We had a concern about senior care facilities, senior home apartment complexes and the like, adult foster care and we didn't have enough of the Abbott Rapid Tests at that time," said Berry, explaining that at that time the city began working with Jackson, MI based Garcia Lab.

"It really helped us to address and control the spread among the senior population," said Berry.

This use of local labs is, according to Levy, a key-factor in testing turnaround.

"Everybody looked to the big lab companies first, figured thats just the simplest way to do it. They became overwhelmed and there wasnt the ready accessibility of these smaller labs to run the tests," he said, explaining that he also initially was using a national lab Quest for his testing of frontline workers at the start of the pandemic, but soon had to look for other solutions.

"We were getting two to three day turn around times initially, that gradually became seven to nine-day turn around times," he said. "We started to look for other lab sources."

Today he works with a number of local labs. But finding them wasn't easy.

"The relationships that weve developed with labs have come either through someone who knows somebody or somebody who knows were in the testing business so to say and has reached out to us," said Levy, explaining that it's still very much a word-of-mouth system.

"Some of it is a lack of familiarity and some of it is just a lack of understanding of the business," he continued.

One lab he works with is NxGen in Grand Rapids.

Prior to COVID-19 the lab focused on genetic testing, working with OBGYNs across the country. They made the transition to COVID-19 tests in the winter when they saw the pandemic coming closer to home. But even as they made the shift, they still say they're not operating at full capacity.

"We started reaching out to I call them the three Fs: friends, family, and fools and asking them for help and connecting us with the right people," said CEO Alan Mack, explaining that while NxGen could process 9,000 tests daily, it is only processing only about 2,500 tests.

"We didnt have some magical Rolodex that put us in touch with all the hospitals and all the other laboratories," he said, explaining that in May he actually reached out to some of the bigger, national testing companies to see if he could take on some of their cases to help reduce times.

"We reached out to a couple of them to say, 'hey we have unused capacity, wed love to be able to help you out'" he said, explaining the response was a resounding no.

"They told us to go pound sand and they dont need our help, he said, adding: "At the same time there are a lot of patients waiting two weeks for their results."

While big testing labs being inundated with tests from other states can play a role in test turnaround time, Mack contends there are other factors at play. He points to supply scarcity still impacting test-turn around.

In September, for example, Henry Ford Health System told the state that while they had the capacity to turn around 1,500 tests a day. Supply constraints, however, reduced that number to only 670 tests. They were still, however, running 1,400 tests daily.

When hospital labs are overwhelmed, according to Mack, they can send out tests to outside labs. The NxGen CEO, however, said this doesn't always happen.

"It amounts to about $24 per sample loss when they send these samples out," he said, pointing to the fact that Michigan is a "no mark up" state, which means hospitals must charge what a lab charges, even if they lose money sending a sample out.

"If theyre having to send thousands of these per day well," he continued, "that adds up very quickly and it becomes a significant financial issue for that institution."

According to the Michigan Department of Health and Human Services, the current turnaround time for a COVID-19 test is two to three days. But this statement comes with an important caveat: "turnaround time varies by laboratory."

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Wait times to get COVID test results can vary here's why - WXYZ

Sponsored Content by the Janssen Pharmaceutical Companies of Johnson & Johnson

When it comes to new therapies, patients with lung cancer face a significant global unmet medical need. Not only does lung cancer have the highest mortality rate of all cancers worldwide, its associated with significant heterogeneity with many driver mechanisms that make it complex and difficult to treat.

The driver mechanisms we have come to understand have provided important insights into new approaches for treating lung cancer, said Matt Lorenzi, PhD., Vice President, Disease Area Leader, Solid Tumor Targeted Therapy, Janssen. Through deeper knowledge about the biology of lung cancer, we are making progress in the advancement of precision medicines that target specific pathways, including patients who have developed a resistance to other therapies.

Ongoing research efforts are continuing to show promise. Targeted therapy approaches that have derived from an understanding of driver mechanisms have helped contribute to a decline in mortality from non-small cell lung cancer (NSCLC), the most common type of lung cancer, as recently reported in The New England Journal of Medicine. In addition, immunotherapy-based approaches to reactivate or redirect a patients immune system for tumor targeting are standard of care or showing future promise, respectively.

For key oncogenic driver pathways, researchers are learning much more about the role that various genetic mutations and alterations play, and development efforts are focused on precisely targeting these defects. One of the most common genetic alterations in NSCLC is epidermal growth factor receptor (EGFR), a mutation that helps cells grow and divide. While targeting EGFR has proven to be an effective treatment intervention, tumors eventually become resistant to treatment. Therefore, the role of bispecific therapies, meaning treatments that target more than one pathway, is becoming increasingly important in the treatment of lung and other types of cancer, along with new combination-based regimens.

As researchers learn more about non-small cell lung cancer specifically as it relates to how certain genetic factors can influence the severity of disease and how a patient responds to treatment the importance of genetic testing is becoming clear, as is the importance of novel modalities and combination therapies, said Lorenzi. The complexity of lung cancer highlights the importance of developing regimens that incorporate multiple mechanisms of action to target the key pathways underlying the disease. We aim for treatment to act against each persons unique cancer, as effectively and safely as possible.

While targeted therapies are among the most discussed current research avenues, other areas are proving promising as well. One uses an approach called synthetic lethality against additional genetic alterations in lung cancer, and another uses immune cell re-direction to leverage the immune system to specifically target lung cancer cells with tumor-associated antigens.

These therapeutic developments offer a promising outlook for the future of lung cancer treatment and are further complemented by exciting efforts underway through the Johnson & Johnson Lung Cancer Initiative, which are focused on unique approaches to intercept the disease at its earliest stage or to prevent it altogether.

Despite many encouraging treatment advances in lung cancer, its five-year survival rate remains among the lowest of any cancer. Improving this statistic will require the ongoing development of novel treatments, the identification of strategic collaborators, and the advancement of scientific leadership in disease prevention and interception. As an organization that has been at the forefront of the discovery and development of new cancer therapies for more than a decade, Janssen, together with the Johnson & Johnson Lung Cancer Initiative, is committed to advancing novel approaches to support efforts throughout the medical community to transform the trajectory of lung cancer.

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Addressing Unmet Medical Needs of Patients with Lung Cancer - Cancer Therapy Advisor

Overview for Direct-to-consumer Genetic Testing Market Helps in providing scope and definitions, Key Findings, Growth Drivers, and Various Dynamics.

The global Direct-to-consumer Genetic Testing market focuses on encompassing major statistical evidence for the Direct-to-consumer Genetic Testing industry as it offers our readers a value addition on guiding them in encountering the obstacles surrounding the market. A comprehensive addition of several factors such as global distribution, manufacturers, market size, and market factors that affect the global contributions are reported in the study. In addition the Direct-to-consumer Genetic Testing study also shifts its attention with an in-depth competitive landscape, defined growth opportunities, market share coupled with product type and applications, key companies responsible for the production, and utilized strategies are also marked.

This intelligence and 2026 forecasts Direct-to-consumer Genetic Testing industry report further exhibits a pattern of analyzing previous data sources gathered from reliable sources and sets a precedented growth trajectory for the Direct-to-consumer Genetic Testing market. The report also focuses on a comprehensive market revenue streams along with growth patterns, analytics focused on market trends, and the overall volume of the market.

Moreover, the Direct-to-consumer Genetic Testing report describes the market division based on various parameters and attributes that are based on geographical distribution, product types, applications, etc. The market segmentation clarifies further regional distribution for the Direct-to-consumer Genetic Testing market, business trends, potential revenue sources, and upcoming market opportunities.

Download PDF Sample of Direct-to-consumer Genetic Testing Market report @https://www.arcognizance.com/enquiry-sample/1370303

Key players in the global Direct-to-consumer Genetic Testing market covered in Chapter 4:Myriad Genetics, Inc.23andMe, Inc.InvitaeAmbry GeneticsLaboratory Corporation of AmericaAfrican AncestryMyHeritageAncestrybyDNACounsyl, Inc.Pathway GenomicsDNA Services of AmericaPositive Bioscience Ltd.Quest DiagnosticsSonora Quest LaboratoriesGene by GeneMapmygenome

In Chapter 11 and 13.3, on the basis of types, the Direct-to-consumer Genetic Testing market from 2015 to 2026 is primarily split into:Diagnostic screeningPrenatal, newborn screening, and pre-implantation diagnosisRelationship testing

In Chapter 12 and 13.4, on the basis of applications, the Direct-to-consumer Genetic Testing market from 2015 to 2026 covers:HealthNutritionFitness

Brief about Direct-to-consumer Genetic Testing Market Report with [emailprotected]https://www.arcognizance.com/report/global-direct-to-consumer-genetic-testing-market-report-2020-by-key-players-types-applications-countries-market-size-forecast-to-2026-based-on-2020-covid-19-worldwide-spread

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:North America (Covered in Chapter 6 and 13)United StatesCanadaMexicoEurope (Covered in Chapter 7 and 13)GermanyUKFranceItalySpainRussiaOthersAsia-Pacific (Covered in Chapter 8 and 13)ChinaJapanSouth KoreaAustraliaIndiaSoutheast AsiaOthersMiddle East and Africa (Covered in Chapter 9 and 13)Saudi ArabiaUAEEgyptNigeriaSouth AfricaOthersSouth America (Covered in Chapter 10 and 13)BrazilArgentinaColumbiaChileOthers

Get 20% complementary customization along with purchase of Direct-to-consumer Genetic Testing Industry [emailprotected]https://www.arcognizance.com/purchase/1370303

Some Point of Table of Content:

Chapter One: Report Overview

Chapter Two: Global Market Growth Trends

Chapter Three: Value Chain of Direct-to-consumer Genetic Testing Market

Chapter Four: Players Profiles

Chapter Five: Global Direct-to-consumer Genetic Testing Market Analysis by Regions

Chapter Six: North America Direct-to-consumer Genetic Testing Market Analysis by Countries

Chapter Seven: Europe Direct-to-consumer Genetic Testing Market Analysis by Countries

Chapter Eight: Asia-Pacific Direct-to-consumer Genetic Testing Market Analysis by Countries

Chapter Nine: Middle East and Africa Direct-to-consumer Genetic Testing Market Analysis by Countries

Chapter Ten: South America Direct-to-consumer Genetic Testing Market Analysis by Countries

Chapter Eleven: Global Direct-to-consumer Genetic Testing Market Segment by Types

Chapter Twelve: Global Direct-to-consumer Genetic Testing Market Segment by Applications12.1 Global Direct-to-consumer Genetic Testing Sales, Revenue and Market Share by Applications (2015-2020)

12.1.1 Global Direct-to-consumer Genetic Testing Sales and Market Share by Applications (2015-2020)

12.1.2 Global Direct-to-consumer Genetic Testing Revenue and Market Share by Applications (2015-2020)

12.2 Health Sales, Revenue and Growth Rate (2015-2020)

12.3 Nutrition Sales, Revenue and Growth Rate (2015-2020)

12.4 Fitness Sales, Revenue and Growth Rate (2015-2020)

Chapter Thirteen: Direct-to-consumer Genetic Testing Market Forecast by Regions (2020-2026) continue

List of tablesList of Tables and FiguresTable Global Direct-to-consumer Genetic Testing Market Size Growth Rate by Type (2020-2026)Figure Global Direct-to-consumer Genetic Testing Market Share by Type in 2019 & 2026Figure Diagnostic screening FeaturesFigure Prenatal, newborn screening, and pre-implantation diagnosis FeaturesFigure Relationship testing FeaturesTable Global Direct-to-consumer Genetic Testing Market Size Growth by Application (2020-2026)Figure Global Direct-to-consumer Genetic Testing Market Share by Application in 2019 & 2026Figure Health DescriptionFigure Nutrition DescriptionFigure Fitness DescriptionFigure Global COVID-19 Status OverviewTable Influence of COVID-19 Outbreak on Direct-to-consumer Genetic Testing Industry DevelopmentTable SWOT AnalysisFigure Porters Five Forces AnalysisFigure Global Direct-to-consumer Genetic Testing Market Size and Growth Rate 2015-2026Table Industry NewsTable Industry PoliciesFigure Value Chain Status of Direct-to-consumer Genetic TestingFigure Production Process of Direct-to-consumer Genetic TestingFigure Manufacturing Cost Structure of Direct-to-consumer Genetic TestingFigure Major Company Analysis (by Business Distribution Base, by Product Type)Table Downstream Major Customer Analysis (by Region)Table Myriad Genetics, Inc. ProfileTable Myriad Genetics, Inc. Production, Value, Price, Gross Margin 2015-2020Table 23andMe, Inc. ProfileTable 23andMe, Inc. Production, Value, Price, Gross Margin 2015-2020Table Invitae ProfileTable Invitae Production, Value, Price, Gross Margin 2015-2020Table Ambry Genetics ProfileTable Ambry Genetics Production, Value, Price, Gross Margin 2015-2020Table Laboratory Corporation of America ProfileTable Laboratory Corporation of America Production, Value, Price, Gross Margin 2015-2020Table African Ancestry ProfileTable African Ancestry Production, Value, Price, Gross Margin 2015-2020Table MyHeritage ProfileTable MyHeritage Production, Value, Price, Gross Margin 2015-2020Table AncestrybyDNA ProfileTable AncestrybyDNA Production, Value, Price, Gross Margin 2015-2020Table Counsyl, Inc. ProfileTable Counsyl, Inc. Production, Value, Price, Gross Margin 2015-2020Table Pathway Genomics ProfileTable Pathway Genomics Production, Value, Price, Gross Margin 2015-2020Table DNA Services of America ProfileTable DNA Services of America Production, Value, Price, Gross Margin 2015-2020Table Positive Bioscience Ltd. ProfileTable Positive Bioscience Ltd. Production, Value, Price, Gross Margin 2015-2020Table Quest Diagnostics ProfileTable Quest Diagnostics Production, Value, Price, Gross Margin 2015-2020Table Sonora Quest Laboratories ProfileTable Sonora Quest Laboratories Production, Value, Price, Gross Margin 2015-2020Table Gene by Gene ProfileTable Gene by Gene Production, Value, Price, Gross Margin 2015-2020Table Mapmygenome ProfileTable Mapmygenome Production, Value, Price, Gross Margin 2015-2020Figure Global Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Global Direct-to-consumer Genetic Testing Revenue ($) and Growth (2015-2020)Table Global Direct-to-consumer Genetic Testing Sales by Regions (2015-2020)Table Global Direct-to-consumer Genetic Testing Sales Market Share by Regions (2015-2020)Table Global Direct-to-consumer Genetic Testing Revenue ($) by Regions (2015-2020)Table Global Direct-to-consumer Genetic Testing Revenue Market Share by Regions (2015-2020)Table Global Direct-to-consumer Genetic Testing Revenue Market Share by Regions in 2015Table Global Direct-to-consumer Genetic Testing Revenue Market Share by Regions in 2019Figure North America Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Europe Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Asia-Pacific Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Middle East and Africa Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure South America Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure North America Direct-to-consumer Genetic Testing Revenue ($) and Growth (2015-2020)Table North America Direct-to-consumer Genetic Testing Sales by Countries (2015-2020)Table North America Direct-to-consumer Genetic Testing Sales Market Share by Countries (2015-2020)Figure North America Direct-to-consumer Genetic Testing Sales Market Share by Countries in 2015Figure North America Direct-to-consumer Genetic Testing Sales Market Share by Countries in 2019Table North America Direct-to-consumer Genetic Testing Revenue ($) by Countries (2015-2020)Table North America Direct-to-consumer Genetic Testing Revenue Market Share by Countries (2015-2020)Figure North America Direct-to-consumer Genetic Testing Revenue Market Share by Countries in 2015Figure North America Direct-to-consumer Genetic Testing Revenue Market Share by Countries in 2019Figure United States Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Canada Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Mexico Direct-to-consumer Genetic Testing Sales and Growth (2015-2020)Figure Europe Direct-to-consumer Genetic Testing Revenue ($) Growth (2015-2020)Table Europe Direct-to-consumer Genetic Testing Sales by Countries (2015-2020)Table Europe Direct-to-consumer Genetic Testing Sales Market Share by Countries (2015-2020)Figure Europe Direct-to-consumer Genetic Testing Sales Market Share by Countries in 2015Figure Europe Direct-to-consumer Genetic Testing Sales Market Share by Countries in 2019Table Europe Direct-to-consumer Genetic Testing Revenue ($) by Countries (2015-2020)Table Europe Direct-to-consumer Genetic Testing Revenue Market Share by Countries (2015-2020)Figure Europe Direct-to-consumer Genetic Testing Revenue Market Share by Countries in 2015Figure Europe Direct-to-consumer Genetic Testing Revenue Market Share by Countries in 2019Figure Germany Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure UK Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure France Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Italy Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Spain Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Russia Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Asia-Pacific Direct-to-consumer Genetic Testing Revenue ($) and Growth (2015-2020)Table Asia-Pacific Direct-to-consumer Genetic Testing Sales by Countries (2015-2020)Table Asia-Pacific Direct-to-consumer Genetic Testing Sales Market Share by Countries (2015-2020)Figure Asia-Pacific Direct-to-consumer Genetic Testing Sales Market Share by Countries in 2015Figure Asia-Pacific Direct-to-consumer Genetic Testing Sales Market Share by Countries in 2019Table Asia-Pacific Direct-to-consumer Genetic Testing Revenue ($) by Countries (2015-2020)Table Asia-Pacific Direct-to-consumer Genetic Testing Revenue Market Share by Countries (2015-2020)Figure Asia-Pacific Direct-to-consumer Genetic Testing Revenue Market Share by Countries in 2015Figure Asia-Pacific Direct-to-consumer Genetic Testing Revenue Market Share by Countries in 2019Figure China Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Japan Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure South Korea Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Australia Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure India Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Southeast Asia Direct-to-consumer Genetic Testing Sales and Growth Rate (2015-2020)Figure Middle East and Africa Direct-to-consumer Genetic Testing Revenue ($) and Growth (2015-2020)continue

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Direct-to-consumer Genetic Testing Market Size 2020, Share, Global Industry Analysis and Competitive Landscape (Effect of the COVID-19 Pandemic) -...

Alex Peters is Dazed Beautys news writer. She picked up the phrase Its all happening from Almost Famous as a teen and it now exclusively makes up her vocabulary. Although in theory she likes the idea of a queer mullet, she is currently rocking the latest lockdown trend: Kajillionaire hair. Here, she shares her choice for Product of the Week a weekly round-up of the Dazed Beauty team and wider communitys must-have buys.

Brand: Augustinus Bader

Product: The Cream

Price: 205

As head of stem cell research at the University of Leipzig, Professor Augustinus Bader spent 30 years working with burns victims, developing a groundbreaking gel in 2008 that could heal third-degree burns without the need for skin grafts. Its this revolutionary stem cell technology the patented Trigger Factor Complex (TFC8) which lies at the heart of his skincare label and its hero product The Cream.

Powered by this technology, with consistent use (the Cream asks that you remain devoted to it for 27 days, using nothing else), the products activate and orchestrate the body's innate regenerative processes which basically means that when you use them your skin cells repair themselves. This helps with reducing the signs of ageing and environmental damage, reducing scarring and redness, and improving tone and texture.

Thats all very scientific, but the most important question is does it actually work? And for me it does. My skin is on the oily side as well as being sensitive and acne-prone so I use the Cream, rather than the Rich Cream which is better suited to dry skin types. The cream itself has a light texture that absorbs quickly and doesnt feel sticky. Two pumps is enough to cover your face and it goes on very smoothly. It has quite a distinctive scent, so if you are nose-sensitive be prepared. Its hard to describe clinical rather than artificial. It comes in a weighty blue and copper tube that feels fancy when youre using it.

I am not always great at using it consistently, particularly since we test out so many products as part of our job, but I have found that when I do, my skin looks noticeably better. My tone is more even and less red, the texture is better, scars look more faded, and I would tentatively say that it seems like I get fewer spots.

I would like to say, however, that the product is definitely on the higher end of the spectrum price-wise, and if you cannot afford it, please do not worry. There are a lot of great options out there that are more affordable and also very effective. If this is something that you can afford, I would highly recommend.

If I were communicating to an alien only using hand gestures, I would describe it with... Just a solid thumbs up. Or through elaborately miming the process of cell renewal.

It sounds like... A reassuring older German professor telling you efferyzing vill be alright and in the background the sound of a fire crackling.

If it was a meme it would be... Sorry to this man. Totally unrelated but its my favourite meme.

The fictional character who would use it is... Bette Porter from The L Word.

Alex Peters's Product of the Week

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The luxury skincare splurge that will help repair your skin cells - Dazed

CRANFORD, N.J., Oct. 7, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, announced that it has signed an exclusive agreement with Novellus Therapeutics Limited ("Novellus") to license iPSC-derived mesenchymal stem cells (iMSCs), and has created a new subsidiary, NoveCite, that will be focused on developing cellular therapies.

NoveCite has a worldwide exclusive license from Novellus, an engineered cellular medicines company, to develop and commercialize NoveCite mesenchymal stem cells ("NC-iMSCs") to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ("ARDS") associated with COVID-19. Several cell therapy companies using donor-derived MSC therapies in treating ARDS have demonstrated that MSCs reduce inflammation, enhance clearance of pathogens and stimulate tissue repair in the lungs. Almost all these positive results are from early clinical trials or under the emergency authorization program.

NC-iMSCs are the next generation mesenchymal stem cell therapy. They are believed to be differentiated and superior to donor-derived MSCs. Human donor-derived MSCs are sourced from human bone marrow, adipose tissue, placenta, umbilical tissue, etc. and have significant challenges (e.g., variable donor and tissue sources, limited supply, low potency, inefficient and expensive manufacturing). iMSCs overcome these challenges because they:

Globally, there are 3 million cases of ARDS every year out of which approximately 200,000 cases are in the United States. The COVID-19 pandemic has added significantly to the number of ARDS cases. Once the COVID patients advance to ARDS, they are put on mechanical ventilators. Death rate among patients on ventilators can be as high as 50% depending on associated co-morbidities. There are no approved treatments for ARDS, and the current standard of care only attempts to provide symptomatic relief.

"NoveCite iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of the high potency seen in Novellus' pre-clinical studies, and because iMSCs are iPSC-derived, and therefore overcome the manufacturing challenges associated with donor derived cells," said Myron Holubiak, Chief Executive Officer of Citius.

"We are excited to be part of this effort because of the promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19," said Dr. Matthew Angel, Chief Science Officer of Novellus. "Our iMSC technology has multimodal immunomodulatory mechanisms of action that make it potentially promising therapy to treat acute respiratory diseases."

About Citius Pharmaceuticals, Inc.

Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Novellus, Therapeutics, Limited

Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its patented non-immunogenic mRNA high specificity gene editing, mutation-free & footprint-free cell reprogramming and serum insensitive mRNA lipid delivery technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellus-inc.com.

About NoveCite iMSC (NC-iMSC)

NoveCite's mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The NC-iMSCs produced from this clonal technique are differentiated from human donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, NC-iMSCs exhibit superior potency and high cell viability. NC-iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. NC-iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

First generation (human donor-derived) MSCs are isolated from donated tissue followed by "culture expansion". Since only a relatively small number of cells are isolated from each donation, first generation MSCs are increased by growing the cells in culture. Unfortunately, these type of MSCs start to lose potency, and ultimately become senescent. Each donation produces a limited number of MSCs, so a continuous supply of new donors is needed to produce commercial scale. The number and quality of MSCs that can be isolated from different donors can vary substantially.

About Acute Respiratory Distress Syndrome (ARDS)

ARDS is an inflammatory process leading to build-up of fluid in the lungs and respiratory failure. It can occur due to infection, trauma and inhalation of noxious substances. ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation. Survivors of ARDS are often left with severe long-term illness and disability. ARDS is a frequent complication of patients with COVID-19. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

Safe Harbor

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risks associated with developing the NoveCite technology as a treatment for ARDS; risks associated with developing any of our product candidates, including any licensed from Novellus, Inc., including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development, including the NoveCite technology; our ability to obtain, perform under and maintain licensing, financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677 x105(M) 646-522-8410ascott@citiuspharma.com

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SOURCE Citius Pharmaceuticals, Inc.

Company Codes: NASDAQ-SMALL:CTXR

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Despite the challenges brought about by Covid-19, leading cosmetic manufacturers, including Mibelle Biochemistry, Cargill Beauty, Givaudan Active Beauty and Lucas Meyer, put forward their most creative innovations for consideration by the in-cosmetics Global Awards jury.

Judged across three categories - Best Active Ingredient, Best Functional Ingredient and Best Green Ingredient - by some of the industrys foremost experts, the awards recognise the cosmetic ingredient manufacturers who are helping to push the boundaries of innovation, while responding to evolving consumer demands.

The winners were announced yesterday during a virtual ceremony from a list of finalists dominated by skin care ingredients.

Scooping both the Gold and Silver awards in the Best Active Ingredient category, Vytrus Biotech was recognised for its Kannabia Sense and Deobiome Noni ingredients.

Kannabia Sense took the top accolade. This probiotic treatment stimulates the skin microbiota to produce an in-situ postbiotic cocktail that promotes the synthesis of cutaneous oxytocin. Recommended for use in sensitive skin treatments, anti-ageing cosmetic products and delicate facial treatments, it is made from plant stem cells of Cannabis sativa.

Deobiome Noni is a prebiotic deodorant treatment that reduces the generation of body odour while allowing the skin to breathe and respecting the skin microbiota.

Closing the category, Mibelle Biochemistry and Clariant Active were announced as this years joint Bronze Award winners.

Alpine Rose Active, Mibelle Biochemistrys novel senolytics concept, was chosen for its ability to eliminate senescent skin cells and protect skin proteins from oxidative stress.

Clariant Active was applauded for Prenylium. Thanks to Clariants Plant Milking technology, Prenylium is extracted from the root of the mulberry tree (Morus Alba) without causing any damage. This innovative and sustainable approach to sourcing helps to stimulate root growth and results in a concentration of prenylated flavonoids 2000% higher than what is typically found in mulberry root extracts.

German cosmetic manufacturer Symrise took the top award in the Best Functional Ingredient category for its Symrise SymEffect Sun. Based entirely on renewable raw materials from responsible sources, the new ingredient combines the advantages of conventional sunscreen products with the increasing sustainability requirements of consumers.

Also demonstrating a sustainable approach to sun protection, Dow Chemical was awarded the Silver award for its SunSpheres BIO SPF Booster, a bio-based and readily biodegradable SPF boost that enables greater SPF efficiency in suncare and daily skincare products.

The category also honoured two bronze award winners: Clariant and Gattefoss. The former was awarded for Velsan Flex which, thanks to its high water solubility and Renewable Carbon Index (RCI) of 93%, offers preservation boosting powers together with broad formulation flexibility. Gattefosss Emulium Dolcea MB a natural origin O/W emulsifier - has the ability to create a wider range of textures, from fluid serum to thick butter in a wide range of applications, such as skincare, suncare, make up and haircare.

As sustainability continues to drive cosmetic manufacturers to assess the ingredients used in their formulations, this years Green Ingredient Award - in partnership with Ecovia Intelligence - recognises the ingredients championing sustainability in the personal care and beauty market.

Henry Lamotte Oils Paradise Nut Oil/Magdalena River Nut Oil scooped the Gold Award for its ability to support the regeneration of the skins lipid film, while improving the water retention capability of the skin, reducing trans-epidermal water loss.

Unveiled as the Silver Award winner, Cargill Beautys FiberDesign Sensation was praised for its approach to sustainability and upcycling. Derived from 100% natural origins, the texturiser and emulsion stabiliser, designed specifically for skincare, is based on citrus peel fibres from the pectin production side stream.

Joining the line-up of award winners, Minasolve SAS scooped the Bronze Award for its A-Leen Aroma-3, a nature-derived perfuming agent that also offers a broad-spectrum antimicrobial effect. It is a 100% natural version of phenylpropanol, it is produced from cassia essential oil.

Cosmetic Ingredients - October 2020

For more information on the latest cosmetic ingredients launches, also read our special issue:

How far will clean beauty go?

Interest in upcycled ingredients expected to rise in the cosmetics industry

Driven by new consumer preferences, demand for cupuau butter is on the rise

in-cosmetics Awards 2020

Ingredient news: Akott, BASF, Berkem, Clariant, Codif, Covestro, DSM, Firmenich, Givaudaun, Grolman, Imerys, Inter Actifs, Lubrizol, Mibelle, Sederma, Seppic, Silab, Symrise

Read online for free or download the pdf version here.

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Private equity company The Carlyle Group has taken legal advice from Latham & Watkins on its acquisit...

Private equity company The Carlyle Group has taken legal advice from Latham & Watkins on its acquisition of the Colombian operations of American hydrocarbon exploration company Occidental Petroleum, for approximately USD 825 million.

White & Case acted as Occidentals legal counsel with Bracewell advising Carlyle International Energy Partners (CIEP), which is providing equity for the transaction.

Of the entire purchase price, USD 700 million is due up front. The transaction is expected to close in the fourth quarter of 2020, subject to meeting customary closing conditions.

Colombia Onshore, which has been present in Colombia for over 40 years, holds its most significant operations in the Llanos Norte Basin in the Department of Arauca, as well as the Middle Magdalena Basin in the Department of Santander.

The former CEO of BP, Tony Hayward, who collaborates with The Carlyle Group to help drive its upstream investments in Colombia, will become the executive chairman of Colombia Onshore following the acquisition, a role to which he will bring a wealth of experience amassed over years in the sector, said head of CIEP, Marcel van Poecke, in a statement.

Hayward expressed gratitude at the prospect of returning to lead a major Colombian oil and gas business, highlighting that Colombian Onshore has a significant presence in all of Colombias principal hydrocarbon basins with a portfolio of attractive onshore investment opportunities from production to development and exploration.

Following the acquisition, The Carlyle Group intends to take on a strategic plan involving field life extension and a focus on operating efficiency, while developing Colombia Onshores environmental, social and governance (ESG) initiatives.

Hayward added that the company has an exemplary track record in ESG - one that [it] will look to continue and improve on, also stating that he is looking forward to continuing the business strategic partnership with [Frankfurt Stock Exchange-listed] Ecopetrol, formerly known as Empresa Colombiana de Petrleos.

London-based corporate partners Sam Newhouse and Simon Tysoe led Latham & Watkins advisory team, alongside New York-based partner Tony Del Pino and associates, Hector Sants, Alan Rozen, Evelyne Girio, James Thomson, Amrita Ahuja, and Pierre-Axel Aberg.

The Carlyle Group enlisted Simpson Thacher & Bartlett on raising EUR 6.4 billion for its Carlyle Europe Partners V fund, in October last year.

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Ex-BP CEO will lead The Carlyle Group's newly acquired Colombia Onshore - ICLG.com

Latest Oral & Dental Probiotics Market Research Report

The research report focuses on target groups of customers to help players to effectively market their products and achieve strong sales in the global Oral & Dental Probiotics market. It someone useful and relevant market information as per the business needs of players. Feature are provided with validated and authorizemarket forecast figures such as CAGR, revenue, production, consumption, and market share. Our straight market data equips players to plan powerful strategies ahead of time.

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The Oral & Dental Probioticsreport will the thorough study of the key business players to grasp their business methods, annual revenue, company profile and their contribution to the worldmarket share.The report covers a huge area of information including an industry overview, comprehensive analysis, definitions and classifications, applications, and expert opinions.

The Oral & Dental Probiotics Market report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, Asia Pacific, South America, Middle East and Africa after evaluating political, economic, social and technological factors impression the market in these regions.

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In the end , The objective of the market research report is the current status of the market and in accordance classifies it into a few object. The report takes into consideration the firstmarket players in every area from over the globe.

View Full Report Description with TOC:https://garnerinsights.com/COVID-19-Impact-on-Global-Oral-&-Dental-Probiotics-Market-Size-Status-and-Forecast-2020-2026

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Oral & Dental Probiotics Market is projected to witness substantial growth by 2026 | Now Foods, Hyperbiotics, Oragenics, Life Extension examined...

Gosselies, Belgium, 5 October 2020, 7am CEST BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, Link Health Pharma Co., Ltd (Link Health) and Shenzhen Pregene Biopharma Company, Ltd (Pregene) today announce the signing of an exclusive license agreement for the manufacturing, clinical development and commercialization of Bone Therapeutics allogeneic, off-the-shelf, bone cell therapy platform ALLOB in China (including Hong Kong and Macau), Taiwan, Singapore, South Korea, and Thailand.

Under the agreement, Bone Therapeutics is eligible to receive up to 55 million in development, regulatory and commercial milestone payments including 10 million in upfront and milestone payments anticipated in the next 24 months. Bone Therapeutics is also entitled to receive tiered double-digit royalties on annual net sales of ALLOB. Bone Therapeutics retains development and commercialization rights to ALLOB in all other geographies outside of those covered by this agreement. As a result, Bone Therapeutics will continue to concentrate on its development and commercialization plans for ALLOB in the US and Europe and novel innovative cell-based products globally.

This collaboration between Bone Therapeutics, Link Health and Pregene expands our geographic reach and demonstrates the global commercial potential of ALLOB,said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. We already have operational experience in Asia with the Phase III clinical trial of our lead product JTA-004 in Hong Kong. We selected Link Health and Pregene to partner with us in Asia as a result of their expertise in advanced therapeutics and cell therapies, their proven track record of development and commercial implementation in Chinese and Asian markets, and Pregenes well established cell therapy manufacturing capacity. Bone Therapeutics will continue to develop the ALLOB cell therapy platform for other markets while exploring additional partnership opportunities in the U.S. and Europe.

The agreement grants Link Health and Pregene exclusive rights to clinically develop and commercialize ALLOB for the treatment of human bone disorders in Greater China, Taiwan, Singapore, South Korea, and Thailand. All rights for China will be transferred to Pregene and Link Health will gain rights for the remaining countries Bone Therapeutics will share its patented proprietary manufacturing expertise for the expansion and differentiation of bone-forming cells and has the option to sell clinical supplies to Link Health and Pregene in preparation for their clinical development of ALLOB.

This collaboration and license agreement for Bone Therapeutics ALLOB provides a strong addition to our pipeline. ALLOB has demonstrated the potential to reduce the recovery time and stimulate bone growth for a variety of bone conditions, and to have a considerable impact on patients lives,said Yan Song, PhD, Chief Executive Officer of Link Health. It is important for Link Health to collaborate with companies that have strong therapeutic product portfolios and entrepreneurial management. This partnership with Bone Therapeutics is a direct result of our shared commitment to appreciate the enormous potential of cell therapy and regenerative medicine.

Pregene now has a flourishing portfolio of CAR-T cell therapy-based cancer treatments. Bone Therapeutics ALLOB provides anallogeneic, off-the-shelf cell therapy that expands our portfolio of cell therapies to include the sizable commercial potential of orthopedics,said Hongjian Li, Co-founder and Chief Executive Officer of Pregene. We expect to be able to leverage our extensive international cell and gene therapy experience to develop Bone Therapeutics ALLOB platform and subsequently launch products in China and Southeast Asian markets.

ALLOB, an allogeneic and off-the-shelf cell therapy product manufactured through a proprietary, scalable production process, consists of human bone-forming cells derived from cultured bone marrow mesenchymal stem cells of healthy adult donors. In preclinical studies ALLOB has shown to reduce healing time in a delayed-union fracture model by half, and has demonstrated good tolerability and signs of efficacy in two Phase IIa studies for two separate indications. The Companys randomized, placebo-controlled, double-blind Phase IIb clinical trial in patients with difficult tibial fractures has received approval from regulatory authorities in six of the seven planned European countries to date, and is expected to enroll the first patient later this year.

About Link Health Pharma Co., Ltd

Link Health is a leading Chinese pharmaceutical company based in Guangzhou, Southern China, focusing on the development of innovative drugs for unmet medical needs.

Link Health has created a highly professional team with diverse expertise in drug development, medical affairs and regulatory affairs. Leveraging deep understanding of China market, regulatory environment and strong network with global biopharmaceutical companies, Link Health is well positioned to bring innovative drugs to the market efficiently. The company has a drug development pipeline of 5 clinical stage assets and 1 under NDA reviewing in China.

The company has also established a fully owned subsidiary in Amsterdam, the Netherlands. The Dutch office builds and further strengthen collaborations with global pharma/biotech partners and research institutes.

About Pregene Biopharma Co., Ltd

Shenzhen Pregene Biopharma Co. Ltd is a leading enterprise in the cell and gene therapy field with the core technology for industrialization. The companys core team comes from well-known institutions and companies including the Academy of Military Medical Sciences, the University of Toronto, and the US FDA.

Pregene has established the gene editing platform, viral vector and cell production platform, nanobody selection platform and other small to pilot trial manufacturing system, with total investment over 100 million CNY. It has the laboratories and GMP plants for cell and gene therapy of over 10,000 square meter.

The company focuses on the research and development of cell and gene therapy drugs, and participated in the drafting the national standard Considerations for CAR-T Cell Quality Study and Non-clinical Evaluation issued by the National Institutes for Food and Drug Control in June 2018. The CAR-T cell therapy for the treatment of multiple myeloma have obtained NMPA IND clearance as the Class I new drug, which is the first in China and fastest in the world using the humanized single domain antibody in CAR construct, and phase I clinical trials are now in progress. Other pipelines such as CAR-T, TCR-T and mRNA drugs for tumors, autoimmune diseases and other indications are in the development at different stages. The company has broad development prospects with the abundant backup technologies.

Looking forward to the future, the company will build the core capacity in one-stop solution for cell and gene therapy drugs, and fulfill the Express of innovative medicine development from drug discovery to clinical products.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company is ready to start the phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available atwww.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

For US Media and Investor Enquiries:LHA Investor RelationsYvonne BriggsTel: +1 310 691 7100ybriggs@lhai.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Continued here:
Bone Therapeutics, Link Health and Pregene to develop and commercialize the ALLOB allogeneic bone cell therapy platform in China and Southeast Asia -...

LONDON, UK / ACCESSWIRE / October 6, 2020 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce the following update on its activities.

As previously announced, Hemogenyx Pharmaceuticals' CDX bi-specific antibody has the potential to treat Acute Myeloid Leukemia ("AML") directly as well as to provide a benign conditioning regimen for blood stem cell replacement therapy. The Company has now carried out extensive work developing treatments for AML and has to date obtained encouraging results.

As announced on 20 February 2020, the Company has constructed and successfully tested in vivo Chimeric Antigen Receptor ("CAR") programmed T cells ("HEMO-CAR-T") for the potential treatment of AML. HEMO-CAR was constructed using the Company's proprietary humanized monoclonal antibody against a target on the surface of AML cells.

It was also announced that the Company was engaging in additional engineering of HEMO-CAR-T cells to increase their safety and versatility. The Company has now introduced and successfully in vitro tested a safety switch within the HEMO-CAR. The aim of this safety switch is to modulate the activity of HEMO-CAR-T cells and to turn them into a "controllable drug" - SAFE-HEMO-CAR-T. The purpose of these efforts is to dramatically improve the safety and potential versatility of HEMO-CAR-T cells for the treatment of AML and/or conditioning of bone marrow transplants, as well as a number of additional potential indications.

Following the successful completion of these in vitro tests, in vivo tests of the efficacy of SAFE-HEMO-CAR-T against AML are being conducted using a model of AML established on the background of Advanced peripheral blood Hematopoietic Chimera (ApbHC) - humanized mice developed by Immugenyx, LLC, a subsidiary of Hemogenyx Pharmaceuticals. If these in vivo tests are successful, the Company will discuss its findings with its partners under the Sponsored Research Agreement with the University of Pennsylvania, announced on 11 August 2020, with a view to considering the inclusion of SAFE-HEMO-CAR-T in the program of pre-clinical trials currently underway there.

Dr Vladislav Sandler, Chief Executive Officer, commented, "We are encouraged by this new data which demonstrates our continuing progress in the development of novel treatments for blood cancers such as AML. The development of SAFE-HEMO-CAR-T further expands the Company's pipeline and advances it into a cutting-edge area of cell-based immune therapy. We are excited to have developed another unique product candidate that should, if successful, provide a new and potentially effective treatment for blood cancers for which survival rates are currently very poor."

About AML and CAR-T

AML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than 25% in adults) and is currently treated using chemotherapy, rather than the potentially more benign and effective form of therapy being developed by Hemogenyx Pharmaceuticals. The successful development of the new therapy for AML would have a major impact on treatment and survival rates for the disease.

CAR-T therapy is a treatment in which a patient's own T cells, a type of immune cell, are modified to recognize and kill the patient's cancer cells. The procedure involves: isolating T cells from the patient, modifying the isolated T cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient's cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the release of this announcement.

Enquiries:

Hemogenyx Pharmaceuticals plc

Home

Dr Vladislav Sandler, Chief Executive Officer & Co-Founder

headquarters@hemogenyx.com

Peter Redmond, Director

peter.redmond@hemogenyx.com

SP Angel Corporate Finance LLP

Tel: +44 (0)20 3470 0470

Matthew Johnson, Vadim Alexandre, Soltan Tagiev

Peterhouse Capital Limited

Tel: +44 (0)20 7469 0930

Lucy Williams, Duncan Vasey, Charles Goodfellow

About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO) headquartered in London, with its US operating subsidiaries, Hemogenyx LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility.

The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.

For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. The Company's technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit http://www.rns.com.

SOURCE: Hemogenyx Pharmaceuticals PLC

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Hematopoietic Stem Cell Transplantation (HSCT) Market Scenario 2020-2026:

The Global Hematopoietic Stem Cell Transplantation (HSCT) market exhibits comprehensive information that is a valuable source of insightful data for business strategists during the decade 2014-2026. On the basis of historical data, Hematopoietic Stem Cell Transplantation (HSCT) market report provides key segments and their sub-segments, revenue and demand & supply data. Considering technological breakthroughs of the market Hematopoietic Stem Cell Transplantation (HSCT) industry is likely to appear as a commendable platform for emerging Hematopoietic Stem Cell Transplantation (HSCT) market investors.

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Topmost Leading Manufacturer Covered in this report:Escape Therapeutics Inc., Cryo-Save AG, Regen Biopharma Inc., CBR Systems Inc., ViaCord Inc., Lonza Group Ltd., Pluristem Therapeutics Inc., China Cord Blood Corp.

Product Segment Analysis: Allogeneic, Autologous

Application Segment Analysis:Peripheral Blood Stem Cells Transplant (PBSCT), Bone Marrow Transplant (BMT), Cord Blood Transplant (CBT)

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Regional Analysis For Hematopoietic Stem Cell Transplantation (HSCT)Market

North America(the 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.)The Middle East and Africa(Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Market Synopsis:The market research report consists of extensive primary research, as well as an in-depth analysis of the qualitative and quantitative aspects by various industry specialists and professionals, to gain a deeper insight into the market and the overall landscape.

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To analyze and forecast the market size of Hematopoietic Stem Cell Transplantation (HSCT)Industry in theglobal market. To study the global key players, SWOT analysis, value and global market share for leading players. To determine, explain and forecast the market by type, end use, and region. To analyze the market potential and advantage, opportunity and challenge, restraints and risks of global key regions. To find out significant trends and factors driving or restraining the market growth. To analyze the opportunities in the market for stakeholders by identifying the high growth segments. To critically analyze each submarket in terms of individual growth trend and their contribution to the market. To understand competitive developments such as agreements, expansions, new product launches, and possessions in the market. To strategically outline the key players and comprehensively analyze their growth strategies.

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At last, the study gives out details about the major challenges that are going to impact market growth. They also report provides comprehensive details about the business opportunities to key stakeholders to grow their business and raise revenues in the precise verticals. The report will aid the companys existing or intend to join in this market to analyze the various aspects of this domain before investing or expanding their business in the Hematopoietic Stem Cell Transplantation (HSCT) markets.

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Hematopoietic Stem Cell Transplantation (HSCT) Market to eyewitness massive growth by 2026 | Escape Therapeutics Inc., Cryo-Save AG, Regen Biopharma...

The market research report on the Stem Cell Therapy Market provides a comprehensive analysis of the market dynamics, including development trends, application, types, competitive environment, value chain optimization, and region. Besides this, the report also provides key statistics on the Stem Cell Therapy Market status of the leading market players, key trends, and potential growth opportunities in the market.

The Stem Cell Therapy Market was valued at USD 117.66 Million in 2019 and is projected to reach USD 255.37 Million by 2027, growing at aCAGR of 10.97% from 2020 to 2027.

These study reports are designed with the goal to help the reader in favorable retrieve information and make decisions that are helpful to grow their business. Further, it also provides an examination of the economic synopsis, along with the benefits, drivers, restraints, production, supply, demand, and the level of market growth.

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The varying landscape for the overall Stem Cell Therapy industry is offered in the report providing a comprehensive pattern of the Stem Cell Therapy industry and its rapidly changing market landscape. The details mentioned in the report can assist the players in formulating strategies and approaches to gain a robust footing in the industry. Profitable insights and analytical data have been covered in the report to offer insight into global expansion strategies. Each key manufacturer and producer have been thoroughly assessed in the report.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The market report sheds light on the latest strategic developments and growth patterns of the market players to provide a clear view. The report is an investigative study that provides insights for the players to formulate their business expansion strategies and expand their footing in the market.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

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Table of Content:

Market Overview: This is the first section of the report that includes an overview of the scope of products offered in the Stem Cell Therapy market, segments by product and application, and market size.

Market Competition by Player: Here, the report shows how the competition in the Stem Cell Therapy market is growing or decreasing based on deep analysis of market concentrate rate, competitive situations and trends, expansions, merger and acquisition deals, and other subjects. It also shows how different companies are progressing in the Stem Cell Therapy market in terms of revenue, production, sales, and market share.

Company Profiles and Sales Data: This part of the report is very important as it gives statistical as well as other types of analysis of leading manufacturers in the Stem Cell Therapy market. It assesses each and every player studied in the report on the basis of main business, gross margin, revenue, sales, price, competitors, manufacturing base, product specification, product application, and product category.

Market Status and Outlook by Region: The report studies the status and outlook of different regional markets such as Europe, North America, the MEA, Asia Pacific, and South America. All of the regional markets researched about in the report are examined based on price, gross margin, revenue, production, and sales. Here, the size and CAGR of the regional markets are also provided.

Market by Product: This section carefully analyzes all product segments of the Stem Cell Therapy market.

Market by Application: Here, various application segments of the Stem Cell Therapy market are taken into account for research study.

Market Forecast: It starts with revenue forecast and then continues with sales, sales growth rate, and revenue growth rate forecasts of the Stem Cell Therapy market. The forecasts are also provided taking into consideration product, application, and regional segments of the Stem Cell Therapy market.

Upstream Raw Materials: This section includes industrial chain analysis, manufacturing cost structure analysis, and key raw materials analysis of the Stem Cell Therapy market.

Marketing Strategy Analysis, Distributors: Here, the research study digs deep into behavior and other factors of downstream customers, distributors, development trends of marketing channels, and marketing channels such as indirect marketing and direct marketing.

Research Findings and Conclusion: This section is solely dedicated to the conclusion and findings of the research study on the Stem Cell Therapy market.

Appendix: This is the last section of the report that focuses on data sources, viz. primary and secondary sources, market breakdown and data triangulation, market size estimation, research programs and design, research approach and methodology, and the publishers disclaimer.

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Stem Cell Therapy Market Growth Factors, Rising Trends and Outlook 2020 to 2027 - X Herald

Massachusetts-based AVROBIO announced today that it has entered an exclusive global license agreement, as well as a collaborative research funding agreement, with The University of Manchester. Together, the university and AVROBIO will look into an investigational lentiviral gene therapy for mucopolysaccharidosis type II (MPS II), or Hunter syndrome.

The condition, which impacts an estimated one in 100,000 males worldwide, causes complications throughout the body and brain. Children with severe cases typically show symptoms beginning in their toddler years. At the moment, the standard of care is weekly enzyme replacement therapy, but it does not halt progression of the disease or address cognitive issues that may arise.

We believe a lentiviral gene therapy approach is well suited to treat a progressive and pervasive disease such as Hunter syndrome, which affects organs throughout the body and severely impairs cognitive function. If we treat children early, before their symptoms arise, we hope to prevent the tragic complications that rob these young children of their futures, said Geoff MacKay, AVROBIOs president and CEO. We believe our deep experience with investigational gene therapies for lysosomal disorders will enable us to efficiently move the program through clinical development in collaboration with Prof. Brian Bigger, who has done tremendous work to develop and optimize this investigational gene therapy. Were proud to add this program to our leading lysosomal disorder pipeline and excited about its potential to change the lives of patients and families living with Hunter syndrome.

The investigational gene therapy, titled AVR-RD-05, includes ex vivo transduction of the patients own hematopoietic stem cells with a therapeutic transgene. The transgene is meant to express functional enzymes that the patient needs to maintain cellular health. When reinfused back into the patient, the modified stem cells are designed to engraft in the bone marrow and produce generations of daughter cells, each carrying the transgene.

This is just one company looking toward making an impact in the MPS II realm as of late. REGENXBIO announced at the end of September that it was expanding its RGX-121 program, looking into the treatment of MPS II. RGX-121 is an investigational one-time gene therapy that uses the AAV9 vector to deliver the gene that encodes the iduronate-2-sulfatase (I2S) enzyme directly to the central nervous system.

An ongoing Phase I/II study is evaluating a single intracisternal administration of RGX-121 in severe instances of MPS II in patients under the age of five. As of Sept. 16, RGX-121 was reported to be well-tolerated in patients and there were no drug-related serious adverse events.

"MPS II is a serious and debilitating lysosomal disease that affects 1 in 100,000 children, and available treatments are inadequate to treat the neurodegenerative manifestations of the disease, said Terri Klein, President and Chief Executive Officer of the National MPS Society. Initiating a natural history study will increase the understanding of neurocognitive effects and key biomarkers of severe MPS II, and is critical to advancing the development of new treatment options. We are grateful for REGENXBIO's dedication to MPS and commitment to share the learnings from this observational study with the community.

REGENXBIO has also announced that the U.S. Food and Drug Administration cleared an Investigational New Drug application. The company plans on initiating a second Phase I/II multicenter, open-label trial of RGX-121 for the treatment of pediatric patients with severe MPS II between the ages of five and 18.

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AVROBIO and University of Manchester Enter Agreement for MPS II Research - BioSpace

A diagnosis of acute myeloid leukemia (AML) is particularly challenging in older adults, whose age makes them highly susceptible to the disease and treatment-related toxicity. To help patients and practitioners navigate the clinical decision-making process, the American Society of Hematology (ASH) convened an panel of experts who conducted a thorough review of the literature. The result of their work can be found in a new set of guidelines for the treatment of newly diagnosed AML in older adults.

Dr Mikkael Sekeres

Medscape spoke with Mikkael Sekeres, MD, chair of the ASH AML guideline panel and director of the Leukemia Program at Cleveland Clinic Taussig Cancer Institute. Sekeres shared the rationale behind the panel's key recommendations and the importance of keeping the patient's goals in mind.

Medscape: What is the average life expectancy of a 75-year-old developing AML compared with someone of the same age without AML?

Dr Sekeres: A 75-year-old developing AML has an average life expectancy measured in fewer than 6 months. Somebody who is 75 without leukemia in the United States has a life expectancy that can be measured in a decade or more. AML is a really serious diagnosis when someone is older and significantly truncates expected survival.

What is the median age at AML diagnosis in the United States?

About 67 years.

What are the biological underpinnings for poor outcomes in older AML patients?

There are a few of them. Older adults with AML tend to have a leukemia that has evolved from a known or unknown previous bone marrow condition such as myelodysplastic syndrome. Older adults also have worse genetics driving their leukemia, which makes the leukemia cells more resistant to chemotherapy. And the leukemia cells may even have drug efflux pumps that extrude chemotherapy that tries to enter the cell. Finally, older adults are more likely to have comorbidities that make their ability to tolerate chemotherapy much lower than for younger adults.

In someone who is newly diagnosed with AML, what initial options are they routinely given?

For someone who is older, we divide those options into three main categories.

The first is to take intensive chemotherapy, which requires a 4-6 week hospitalization and has a chance of getting somebody who is older into a remission of approximately 50% to 60%. But this also carries with it significant treatment-related mortality that may be as high as 10% to 20%. So, I have to look my older patients in the eyes when I talk about intensive chemotherapy and say, "There is a 1 in 10 or 1 in 5 chance that you might not make it out of the hospital alive."

The second prong is lower-dose therapy. While the more-intensive therapy requiring hospitalization does have a low, but real, chance of curing that person, less-intensive therapy is not curative. Our best hope with less-intensive therapy is that our patients enter a remission and live longer. With less-intensive therapy, the chance that someone will go into remission is probably around 20%, but again it is not curative. The flip side to that is that it improves a person's immediate quality of life, because they're not in the hospital for 4 to 6 weeks.

The final prong is to discuss palliative care or hospice upfront. We designed these guidelines to be focused on a patient's goals of therapy and to constantly revisit those goals to make sure that the treatment options we are offering are aligning with them.

The panel's first recommendation is to offer antileukemic therapy over best supportive care in patients who are appropriate candidates. Can you provide some context for this recommendation?

Doesn't that strike you as funny that we even have to make a recommendation about getting chemotherapy? Some database studies conducted over the past two decades show that, as recently as 15 years ago, only one third of patients who were over the age of 65 received any type of chemotherapy for AML. More recently, as we have had a few more drugs available that allow us to use lower-dose approaches, that number has crept up to probably about 50%. We still have half the patients offered no therapy at all. So, we felt that we had to deliberately make a recommendation saying that, if it aligns with a patient's goals, he or she should be offered chemotherapy.

The second recommendation is that patients considered candidates for intensive antileukemic therapy should receive it over less-intensive antileukemic therapy. How did you get to that recommendation?

There is a debate in our field about whether older adults should be offered intensive inpatient chemotherapy at all or whether we should be treating all of them with less-intensive therapy. There are not a huge amount of high-quality studies out there to answer some of these questions, in particular whether intensive chemotherapy should be recommended over less-intensive therapy. But with the available evidence, what we believe is that patients live longer if they are offered intensive antileukemic chemotherapy. So, again, if it aligns with a patient's goals, we support that patient receiving more-intensive therapy in the hospital.

What does the panel recommend for patients who achieve remission after at least a single cycle of intensive antileukemic therapy and who are not candidates for allogeneic hematopoietic stem cell transplantation?

Once again, this may seem at first blush to be an obvious recommendation. The standard treatment of someone who is younger with AML is to offer intensive inpatient chemotherapy to induce remission. This is followed by a few cycles of chemotherapy, mostly in an outpatient setting, to consolidate that remission.

What is the underlying philosophy for this approach?

Every time we give chemotherapy, we probably get about a 3 to 4 log kill of leukemia cells. Imagine when a person first presents with AML, they may have 10 billion leukemia cells in his or her body. We are reducing that 3 to 4 log with the first course of chemotherapy.

When we then look at a bone marrow biopsy, it may appear to be normal. When leukemia is at a lower level in the body, we simply can't see it using standard techniques. But that doesn't mean the leukemia is gone. For younger patients, we give another cycle of chemotherapy, then another, then another, and then even another to reduce the number of leukemia cells left over in the body until that person has a durable remission and hopefully cure.

For someone who is older, the data are less clear. While some studies have shown that if you give too much chemotherapy after the initial course, it doesn't help that much, there is a paucity of studies that show that any chemotherapy at all after the first induction course is helpful. Consequently, we have to use indirect data. Older people who are long-term survivors from their acute leukemia always seem to have gotten more than one course of chemotherapy. In other words, the initial course of chemotherapy that a patient receives in the hospital isn't enough. They should receive more than that.

What about older adults with AML considered appropriate for antileukemic therapy but not for intensive antileukemic therapy?

This again gets to the question of what are a patient's goals. It takes a very involved conversation with a person at the time of their AML diagnosis to determine whether he or she would want to pursue an aggressive approach or a less-aggressive approach. If a person wants a less-aggressive approach, and wants nothing to do with a hospital stay, then he or she is also prioritizing initial quality of life. In this recommendation, based on existing studies, we didn't have a preference for which of the available less-aggressive chemotherapies a person selects.

There's also debate about what to do in those considered appropriate for antileukemic therapy, such as hypomethylating agents (azacitidine and decitabine) or low-dose cytarabine, but not for intensive antileukemic therapy. What did the available evidence seem to indicate about this issue?

There have been a lot of studies trying to add two drugs together to see if those do better than one drug alone in patients who are older and who choose less-intensive therapy. The majority of those studies have shown no advantage to getting two drugs over one drug.

Our recommendation is that in these situations a patient gets one drug, not two, but there are a couple of caveats. One caveat is that there has been a small study showing the effectiveness of one of those low-dose chemotherapies combined with the drug glasdegib. The second caveat is that there have been results presented combining one of these low-dose chemotherapies with the drug venetoclax. One of those was a negative study, and another was a positive study showing a survival advantage to the combination vs the low-dose therapy alone. We had to couch our recommendation a little bit because we knew this other study had been presented at a conference, but it hadn't come out in final form yet. It did recently, however, and we will now revisit this recommendation.

The other complicated aspect to this is that we weren't 100% convinced that the combination of venetoclax with one of these lower-dose therapies is truly less-intensive therapy. We think it is starting to creep up toward more-intensive chemotherapy, even though it is commonly given to patients in the outpatient setting. It gets into the very complicated area of what are we defining as more-intensive therapy and less-intensive therapy.

Is there a recommended strategy for older adults with AML who achieve a response after receiving less-intensive therapy?

This is also challenging because there are no randomized studies in which patients received less-intensive therapy for a finite period of time vs receiving those therapies ad infinitum. Given the lack of data and also given a lot of anecdotal data out there about patients who stopped a certain therapy and relapsed thereafter, we recommended that patients continue the less-intensive therapy ad infinitum. So as long as they are receiving a response to that therapy, they continue on the drug.

Of course, there are also unique considerations faced by older patients who are no longer receiving antileukemic therapy, and have moved on to receiving end-of-life care or hospice care. What advice do the guidelines offer in this situation?

There are a lot of aspects of these recommendations that I think are special. The first is the focus on patient goals of care at every point in these guidelines. The second is that the guidelines follow the real disease course and a real conversation that doctors and patients have at every step of the way to help guide the decisions that have to be made in real time.

A problem we have in the United States is that once patients enter a hospice, most will not allow blood transfusions. One reason is that some say it is antithetical to their philosophy and consider it aggressive care. The second reason is that, to be completely blunt, economically it doesn't make sense for hospices to allow blood transfusions. The amount that they are reimbursed by Medicare is much lower than the cost of receiving blood in an infusion center.

We wanted to make a clear recommendation that we consider transfusions in a patient who is in a palliative care or hospice mode to be supportive and necessary, and that these should be provided to patients even if they are in hospice, and as always if consistent with a patient's goals of care.

How does a patient's age inform the discussion surrounding what intensity treatment to offer?

With younger adults, this is not as complicated a conversation. A younger person has a better chance of being cured with intensive chemotherapy and is much more likely to tolerate that intensive chemotherapy. For someone who is younger, we offer intensive chemotherapy and the chance of going into remission is higher, at 70% to 80%. The chance of dying is lower, usually less than 5%. It is an easy decision to make.

For an older adult, the riskbenefit ratio shifts and it becomes a more complicated option. Less-intensive therapy or best supportive care or hospice become viable.

Are there other factors confounding the treatment decision-making process in older adults with AML that practitioners should consider?

Someone who is older is making a different decision than I would. I have school-aged children and believe that my job as a parent is to successfully get them to adulthood, so I would take any treatment under the sun to make sure that happens. People who have lived a longer life than I have may have children and even grandchildren who are adults, and they might have different goals of care. My goals are not going to be the same as my patient's goals.

It is also harder because someone who is older may feel that he or she has lived a good life and doesn't need to go through heroic measures to try to be around as long as possible, and those goals may not align with the goals of that person's children who want their parent to be around as long as possible. One of the confounding factors in this is navigating the different goals of the different family members.

Dr Sekeres has disclosed no relevant financial relationships.

Kate O'Rourke is a freelance writer in Portland, Maine. She has covered the field of oncology for over 10 years.

For more news, follow Medscape on Facebook, Twitter, Instagram, andYouTube.

Continued here:
A Uniquely Patient-Focused Take on Treating AML in Older Adults - Medscape

WASHINGTON Heres a look at how Georgias members of Congress voted over the previous week.

Along with its roll call votes this week, the House also passed the Cyber Sense Act (H.R. 360) to require the Secretary of Energy to establish a voluntary Cyber Sense program to test the cybersecurity of products and technologies intended for use in the bulk-power system; the Consumer Product Safety Inspection Enhancement Act (H.R. 8134) to support the Consumer Product Safety Commissions capability to protect consumers from unsafe consumer products; the School-Based Allergies and Asthma Management Program Act (H.R. 2468) to increase the preference given in awarding certain allergies and asthma-related grants to states that require certain public schools to have allergies and asthma management programs; and the Effective Suicide Screening and Assessment in the Emergency Department Act (H.R. 4861) to establish a program to improve the identification, assessment and treatment of patients in the emergency department who are at risk of suicide.

DISCLOSING TIES TO UYGHUR LABOR: The House has passed the Uyghur Forced Labor Disclosure Act (H.R. 6270) sponsored by Rep. Jennifer Wexton, D-Va., to require publicly traded companies to disclose whether they have business ties to Chinas Uyghur Autonomous Region in Xinjiang province. Wexton said the requirement would let investors know of a given companys passive complicity or active exploitation of one of the most pressing and ongoing human rights violations of our lifetime. A bill opponent, Rep. Anthony Gonzalez, R-Ohio, said it wrongly tried to have the Securities and Exchange Commission police human rights violations, a role that would be better handled by the Treasury Department. The vote, on Sept. 30, was 253 yeas to 163 nays.

NAYS: Loudermilk R-GA (11th), Allen R-GA (12th), Scott, Austin R-GA (8th), Collins R-GA (9th), Carter R-GA (1st), Woodall R-GA (7th), Ferguson R-GA (3rd), Hice R-GA (10th)

YEAS: Bishop D-GA (2nd), Scott, David D-GA (13th), McBath D-GA (6th), Johnson D-GA (4th)

NOT VOTING: Graves R-GA (14th)

PRESIDENTIAL ELECTION: The House has passed a resolution (H. Res. 1155) sponsored by Rep. Eric Swalwell, D-Calif., reaffirming the Houses commitment to an orderly and peaceful transfer of presidential power after the November election. Swalwell said: The peaceful transition of power is not only a bedrock principle of Americas founding, it is a living ideal that we must exercise and pass down to our children. An opponent, Rep. Matt Gaetz, R-Fla., called the resolution a way for Democrats to attack the president and disguise the fact that they will refuse to accept the election results unless they win. The vote, on Sept. 29, was 397 yeas to 5 nays.

YEAS: Entire delegation, except Collins R-GA (9th), Graves R-GA (14th), who did not vote

DISEASE THERAPIES: The House has passed the Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act (H.R. 4764) sponsored by Rep. Doris O. Matsui, D-Calif. The bill would reauthorize a program for transplanting umbilical cord blood, stem cells, and bone marrow to adults and children suffering from various diseases. The vote, on Sept. 30, was unanimous with 414 yeas.

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YEAS: Entire delegation, except Graves R-GA (14th), who did not vote

FURTHER COVID-19 SPENDING: The House has approved an amendment to the Americas Conservation Enhancement Act (H.R. 925). The amendment would spend $2.2 trillion on new COVID-19 measures, including testing and treatment efforts and unemployment benefits. A supporter, Rep. James P. McGovern, D-Mass., said the spending was needed for families to pay for necessities like food, utilities, and rent during this pandemic. An opponent, Rep. Tom Cole, R-Okla., said the amendment had been hurriedly brought to the floor without minority input or adequate time for review, and that it would not pass the Senate. The vote, on Oct. 1, was 214 yeas to 207 nays.

NOT VOTING: Loudermilk R-GA (11th), Graves R-GA (14th)

YEAS: Bishop D-GA (2nd), Scott, David D-GA (13th), McBath D-GA (6th), Johnson D-GA (4th)

NAYS: Allen R-GA (12th), Scott, Austin R-GA (8th), Collins R-GA (9th), Carter R-GA (1st), Woodall R-GA (7th), Ferguson R-GA (3rd), Hice R-GA (10th)

CONTINUING APPROPRIATIONS: The Senate has passed the Continuing Appropriations Act and Other Extensions Act (H.R. 8337) sponsored by Rep. Nita M. Lowey, D-N.Y., to extend through Dec. 11 funding for health programs, including Medicare, surface transportation, and many other government programs. The vote, on Sept. 30, was 84 yeas to 10 nays.

AFFORDABLE CARE ACT LITIGATION: The Senate has rejected a cloture motion to end debate on a motion to consider a bill (S. 4653) sponsored by Senate Minority Leader Chuck Schumer, D-N.Y., that would block the Justice Department from making arguments in court for cancelling any provision of the 2010 health care reform law (ACA). The vote to end debate on Oct. 1, was 51 yeas to 43 nays, with a three-fifths majority needed for approval.

See the rest here:
Congress Votes | News | albanyherald.com - The Albany Herald

Are you apprehensive about too much hair in your comb and shower, leading to a reduced hair volume and baldness? Does thinning of hair run in your family? Is hair loss a big concern for you? Is it messing with your confidence?

Then you are at the right spot. This article goes in-depth and discusses some key concepts linked to hair loss and technique to prevent it.

The Hair Growth Cycle

In order to achieve the desired hair length, some people either trim their hair regularly or leave them out to grow. Regardless, the hair growth cycle remains undisputed.

Your hair consists of a hair follicle and shaft. Present underneath the scalp, the hair follicle provides anchorage to the hair into the scalp. The hair shaft is the strand of hair made up of proteins. There are three phases of the hair growth cycle.

1. The Anagen Phase

The first phase is called the Anagen phase and corresponds to the growth period. During this phase, rapid cell division occurs in the hair follicles bulb, resulting in the growth of the hair strand. The hair length increases at the roots, with active growth for 2 to 7 years before the dormant period of the hair follicle is reached. During this period, the hair strand can lengthen from 18 to 30 inches long. The final length of the hair varies from individual to individual depending upon their genetic makeup, health, age, and other factors.

2. The Catagen Phase

The Catagen phase in the hair growth cycle is short and lasts for about 2 to 3 weeks. This is the transitional period during which the growth of hair stops, and it gets disconnected from the blood supply. This type of hair is called a club hair.

3. The Telogen Phase

The final stage of hair growth, the Telogen Phase, starts with a resting period and lasts for about 2 months. During this period, the club hair is in the resting phase, and new hair starts to grow beneath it.

Subsequently, the resting club hair falls out, letting the new hair strand to emerge from the scalp. This falling of hair is natural, usually doesnt get noticed, and thus shouldnt be alarming. The typical rate of hair shedding per day is 50 to 100 strands. Every hair strand undergoes the growth phase separately at different timings; thus, you wont notice hair loss in patches simultaneously.

What Is DHT?

Androgenic alopecia, also known as male or female pattern baldness, is a widespread cause behind male and female hair thinning. Although highly prevalent in women, it is more common in men. On average, around 30 million women and 50 million men in the U.S. suffer from this condition.

The phenomenon of alopecia is aggravated by the activity of sex hormones in the body, thereby called androgenic alopecia. One of the androgens responsible for this mechanism is Dihydrotestosterone (DHT), which brings about the development of male sex characteristics.

How Is DHT Produced In The Body?

DHT is produced in your body as a byproduct of the sex hormone, testosterone. 5-Reductase is the enzyme that breaks down about 10% of testosterone into DHT in tissues, including skin, prostate, liver, and hair follicles. While DHT results in body hair growth, it interestingly leads to loss of scalp hair faster and earlier in life. Consequently, blocking this androgen is what makes hair loss therapies effective in preventing hair fall.

How Does DHT Impact The Hair Follicles And Cause Miniaturization?

Researchhas shown that hair follicle miniaturization is the conversion of hair from terminal to vellus type. This process occurs at the follicular level when anagen to telogen ratio reduces, thereby increasing hair loss. It means that the anagen (growth) phases duration is reduced while the telogen phase is prolonged.

Male or female pattern hair loss occurs due to the shortening of the growth phase, which takes place with the miniaturization of the follicles. This signifies that hair cannot grow as long as it would have otherwise grown.

The anagen phase gradually narrows down so much that the new hair does not emerge from the scalp. Telogen hair type is poorly anchored in the scalp, allowing it to fall out easily.

The small-sized follicles lead to thinner hair shafts with each growth cycle. The hair eventually becomes vellus type soft and light hair type present on an infants body.

How Is DHT Blocked To Prevent Hair Loss?

Fortunately, the action of DHT can be blocked by compounds known as DHT blockers. DHT-blocking products include shampoos and oils containing DHT-blocking ingredients like biotin, saw palmetto, ketoconazole, etc. These agents decrease the production of the Alpha-5 Reductase enzyme, which then inhibits the formation of DHT. A combination of these active ingredients in shampoos and oils works by reducing the excess amount of DHT. Thus, it produces a favorable environment for hair growth.

Finasteride (generic name: Propecia) is also a proven DHT blocker. It is a prescription tablet that works well in preventing hair loss and receding hairlines. Finasteride binds to the 5-Reductase enzyme, leading to the inhibition of DHT production.

Using DHT-Blockers To Prevent Hair Loss

The phenomena of hair thinning in males and females occur due to numerous reasons, including underlying health conditions. However, genetics is the most significant factor in male and female pattern hair loss. DHT is another crucial player in causing male or female pattern baldness and must be blocked by using products containing proven DHT-blockers. For example, Hair Restoration Laboratories has a Hair Restore line of products that utilized what the company calls its DHT Halting Technology. Its lineup of shampoos, conditioner and serums contain a boatload of ingredients, such as saw palmetto, caffeine, green tea extract, pumpkin seed oil, and others that are clinically proven to help block DHT when applied topically. By helping to block DHT from attacking your hair follicles, male and female pattern hair loss can be prevented and your follicles can grow new and thicker hair.

In sum, if you wish to halt the progression of alopecia, you need to address and counter that adverse impact of DHT. If not kept in check, androgen alopecia will continue to progress and become worse with time.

References:

1. Ellis K. Hair growth cycle The 3 stages explained. The Hair Lab. (2018). https://www.growgorgeous.co.uk/blog/the-hair-lab/how-does-hair-grow/

2. Anonymous. (August 2020). Androgenetic alopecia. Genetics Home Reference. https://ghr.nlm.nih.gov/condition/androgenetic-alopecia

3. Jewell T. What You Need to Know About DHT and Hair Loss. (January 2019). Healthline. https://www.healthline.com/health/dht#purpose-and-function

4. Levy B. DHT and Male Hair Loss Explained. Hims. (September 2017). https://www.forhims.com/blog/dht-and-male-hair-loss-explained

5. Ravi A. The Best DHT Blockers & How They Can Combat Hair Loss. (July 2020). https://skinkraft.com/blogs/articles/what-is-dht

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Everything About Hair Loss & DHT - The Ritz Herald

Philip Patterson who is responsible for the day to day management of the herd with herdsman, Scott Cromwell, right

In recent years Philip Patterson has been responsible for the day to day running of the milking herd - he has always been keen to try new and innovative ways to manage the herd.

The 300 strong herd of Holsteins have been AI bred for the last four years using a mixture of proven and genomic sires from Genus ABS. Philip has taken the breeding policy a step further during the last 18 months, moving to a full Sexcel and beef strategy and employing a new herdsman to assist with the breeding of the cows, Scott Cromwell.

Sexcel is the name given to Genus ABSs proprietary technology for sexing bovine semen. This innovative technology does not subject the cells to the high pressures, electric currents and shear forces used to produce the sexed semen historically available to farmers. The result has been a superior sexed genetics product that has helped customers maximize their profitability in line with their individual economic herd goals.

Genus ABS have concentrated on developing a product with superior fertility. Data from UK RMS herds, based on 169,693 inseminations, has shown that the Relative Conception Rate (RCR) on maiden heifers is 92% and the improved performance from Sexcel is reaching as high as 94% in 3rd lactation cows. This data set has also shown that Sexcel has delivered up to a 92% skew rate, thats 92 female calves in every 100 born. So more pregnancies per service as well as more females per calving with Sexcel over any other sexed product.

Philip commented: I was keen to try Sexcel to minimise the number of low value Holstein bull calves using the very latest technology available. I started using it in February 2019 and have been extremely pleased with the results. The conception rates have been similar to what we were achieving with conventional semen.

Although the beef income will be important, the British Blue sires are selected to ensure that the cows calve down successfully and start milking well, so particular attention is paid to calving ease when selecting beef bulls.

Gareth Bell, Genus ABS, who works closely with Phillip said: We are aiming to create cows that are well balanced with a willingness to produce high volumes of milk. PLI is followed closely and with Genus having 20 of the top 30 PLI sires, there are lots of options when it comes to choosing sires that will leave more profit in the herd.

The Pattersons herd also uses Genus ABS to help with the day to day management of the herd, through the ABS Partner programme. Action lists are created on a weekly basis to aid with dry offs and also any fertility work carried out. These reports are then used by Scott to monitor the herds reproductive performance and highlight any areas that need attention.

The management reports have helped us become more structured in our approach to fertility. We can see the benefits of the improvements we have made, including increasing the herds overall conception rate and reducing the calving interval, said Scott.

For more information on Sexcel or other Genus ABS products please contact your local Genus ABS representative or the office on 028 38 334426.

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Sexcel The basis of a new plan! - Farming Life