Archive for December, 2019
These Cult Beauty Brands Offer The Most Luxurious Spa Experience At Their Boutiques: Sulwhasoo, La Mer, Dior And More – Singapore Tatler
By Chloe Pek December 20, 2019
How to make the most of your holy grail skincare products at these beauty spas in Singapore
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We all have our favourite beauty brandsit could be a holy grail skincare product or a go-to beauty routine you rely on for a clear, radiant complexion. But are you truly making the most out of your skincare products? Only the experts will knowwhich is why there's no better way to experience your cult favourites than at their boutiques, where assistants are at hand to offer tips and tricks.
These beauty brands below do it better: with a complete spa experience that will leave your skin glowing and your mind, relaxed.
(Related: Biohack Your Way To Beauty And Health Using Your DNA And Stem Cells At These Wellness Retreats Around The World)
Want to harness the full benefits of SK-IIs miracle water? Then the SK-II Boutique Spa by Senze Salus is the place to go. Operating under an exclusive license by SK-II, the spa offers a selection of facials that last between 60 minutes to 105 minutes, catering to a myriad of skincare concerns like hydration, uneven skin tone, and clogged pores.
Besides their trademark miracle water, pure water is also the secret to their holistic spa experience. A four-stage water filtration system ensures that all water used in treatments are free of impurities, and only 100 per cent pure distilled water is used for facial steaming. Theres even a lot of thought put into the water that they serveonly alkaline water for hydration and antioxidant properties.
(Related: Why Water Is The Essence Of SK-II's Spa Treatments)
Currently exclusive to CldePeauBeauts Diamond tier members, the beauty brands SoindeBeaut offers the ultimate experience of their signature skincare ranges. Treatments available include the 60-minute Intensive Brightening Facial Treatment using CldePeauBeauts Key Radiance Care and targeted Brightening range for a radiant, glowing complexion, as well as the 60-minute Firming Supreme Facial Treatment that helps to firm and lift contours while enhancing your glow with the brands Supreme skincare range.
These services are available at CldePeauBeauts Mandarin Gallery flagship and department store counters.
(Related: Cl de Peau Beaut Revamps Its Signature La Crme Face Cream For Spring 2020)
Touted as the temple of Dior beauty, Dior Institut strives to offer a unique sensory experience for every guest. Each treatment begins with a consultation and examination of the skin with a Dior Skincare Expert to address skincare concerns. Then, a massage using Dior Instituts exclusive tissue massage techniques help to soothe customers and relieve muscle tensions.
The wide suite of services include the Brightening and Radiance-Activating Treatment, Age-Delay and Beautifying Treatment, the Dior Homme Treatment for men, and also sculpting treatments for facial contours and around the eyes. Youll also return home with tips and techniques to maximise your beauty routine. Dior Institut can be found at Dior Beauty's The Shoppes at Marina Bay Sands flagship, Robinsons The Heeren, and Tangs at Tang Plaza.
(Related: Dior Makeup's Peter Philips Reveals Why The Brand's New Lipsticks Are Infused With Flower Oil)
Available in Sulwhasoo boutiques at Capitol Building, Ion Orchard, Westgate and the Sulwhasoo Facial Treatment Studio at Tangs, Sulwhasoo offers a suite of facial treatments to address various skin concerns, from the moisturising Essential Treatment to the rejuvenating Timetreasure Renovating Treatment.
A specialised anti-ageing facial for men is also available. Creating a holistic experience for consumers, each treatment begins with a meridian point massage using a fragrance of the customers choice, followed by a foot bath using ginseng peels and red ginseng water. Traditional applicators like jade, amber and white porcelain are also used to enhance the efficacy of the treatments.
(Related: A Holistic Approach To Beauty At The Sulwhasoo Beauty Lounge)
Previously only available at the Ritz-Carlton Spa, fans of La Mer can now indulge in the full pampering experience with the recent opening of La Mers flagship at The Shoppes at Marina Bay Sands, an experiential space complete with a VIP consultation area and a facial suite. On top of the complimentary services available, the flagship also offers a menu of facial services, including the 75-minute Miracle Broth Facial, which harnesses the healing energies of La Mers signature ingredient, the Miracle Broth.
These 5 Skincare Trends Are the Wave of the Future, and You’ll See ‘Em Everywhere in 2020 – POPSUGAR
No longer must you wait until the National Enquirer gets a hot tip from an anonymous source that "various celebrities" are getting facials made from liquefied cells of a baby's foreskin to learn about the latest skincare trends. In 2020, we suggest a slightly more discerning approach: get your forecast on the biggest treatments and ingredients to try in the new year straight from the experts.
To be clear, that doesn't mean the future of skin care is any less exciting or innovative. (As dermatologist Matthew Elias, MD, put it: "2020 is going to be a banner year for skin care.") There will be blood, personalization, and a slight tweak to the lip filler movement you've been seeing everywhere of late. TDLR? The next phase of skincare trends will be anything but boring, and we asked a handful of derms to break down which ones you should be most excited about in 2020.
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These 5 Skincare Trends Are the Wave of the Future, and You'll See 'Em Everywhere in 2020 - POPSUGAR
Cutting through the hype to get to bioprinted human tissue – Livemint
For the first time ever, Israeli scientists in Tel Aviv made a 3D printed artificial heart using a patients own cells," proclaims a Washington Post story headlined Researchers create 3D printed heart on April 17 this year.
In the scientific paper published two days earlier, the Israeli scientists describe how they made a bioink out of heart cells and other materials from a patient, and then bioprinted the tissue in the shape of a tiny heart, which was kept alive in a nutrient solution. Their paper makes it clear that this 3D printed heart could not function like a real heart. But the way the research that was projected in media shows how the idea of 3D printed organs is hyped.
Biotechnology has made significant advances, but its still a long way from creating organs that can be transplanted into people. The vasculaturethe network of blood vessels that feeds the organis a challenge.
Stem cell engineering to grow all the cells of an organ in a personalised way to avoid rejection by the recipients immune system is another challenge. And finally, researchers will have to show that a lab organ will work with all the other organs in a human body.
At the same time, the development of 3D bioprinters in the last few years has raised the prospects of making tissues and organs in a more affordable and consistent way because of the speed and precision of the machines. Advances in related fields like nanotechnology and gene editing are also pushing the needle.
These are exciting times, but for startups rushing into this nascent field with huge potential, its as important to be prudent as brave. One way is to go after low hanging fruit instead of the holy grail.
Shift to clinical use
Something like skin is easier to translate into a clinical setting," says Alok Medikepura Anil, director and co-founder of Bengaluru-based 3D bioprinting startup Next Big Innovation Lab (NBIL), which has made human skin in the lab. The skin has good regenerative properties and most of the function of bioprinted skin is to keep infections away, provide nutrition for skin to regenerate and stop the scarring of wounds. Replicating this is easier than replicating the function of a critical organ such as the heart."
This approach contrasts with that of another Bengaluru-based 3D bioprinting startup Pandorum Technologies, founded in 2011 by two researchers at Indian Institute of Science. Pandorum first tried its hand with liver tissue and more recently announced that it had bio-engineered corneal tissue.
Organ tissue for clinical use will require FDA and other approvals. So thats a very expensive proposition," says angel investor Venkat Raju, who took an interest in Pandorum but eventually made a bet on NBIL whose proprietary Innoskin also has non-clinical use in cosmetics testing.
The regulatory environment is evolving. This year, FDA released an RMAT (regenerative medicine and advanced therapy) policy that includes tissue engineering. The FDA wants to fast-track tissue-engineered products if they have a lot of benefits," says Pooja Venkatesh, NBIL co-founder.
Raju feels that startups like NBIL gaining traction and validation could bridge the current gap between academic research and business.
Theres tonnes of research happening across the globe on bioprinting. But universities are struggling to commercialize their research. The fact that NBIL is getting receptive audiences in academia is because they see an opportunity to push their research out."
The Wake Forest Institute of Regenerative Medicine in the US is one of the leading institutions for research in this field. Researchers there are growing tissues for over 40 different areas of the body. They were the first to transplant a lab-grown organ into a 10-year-old patient.
Made-to-order organs
Dr Anthony Atala, who is now the director of the institute, had taken a piece of the boys bladder and grown a new one in the lab over the course of two months. The lab-grown bladder was then transplanted into the patient.
That boy, Luke Massella, went on to become the captain of his school wrestling team. Pretty much I was able to live a normal life after that," Massella, who is now 28, said in a recent interview on BBC.
Stories like that of Massella stoke excitement over futuristic scenarios where you could get made-to-order organs. But researchers admit that there are many unsolved problems in tissue engineering before complex organs like the heart, kidney and liver can be bioprinted. The crash of well-funded San Diego 3D bioprinting startup Organovo, which hit a brick wall in commercializing liver tissue, reminds us to keep the hype in check.
Sumit Chakraberty is a contributing editor with Mint. Write to him at chakraberty@gmail.com.
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Cutting through the hype to get to bioprinted human tissue - Livemint
A Gene Linked to Male Infertility Has Been Discovered, and It May Account for 50 Percent of Unexplained Cases – Newsweek
Scientists have discovered a gene linked to male infertility, which they hope could help to account for 50 percent of unexplained cases.
Variants of a gene called SYCP2 could be the reason why some men struggle to conceive, according to the authors of a study published in the American Journal of Human Genetics. So far, they have pinpointed them in four men with fertility problems.
Back in 1991, a 28-year-old man who had been unable to conceive for two years and had a very low sperm count was referred to the authors of the study. The team assessed his chromosomes, and found he had what is known as a chromosomal rearrangement, where parts of the chromosome might be missing, duplicated, or moved around. This appeared to make the SYCP2 gene 20 times more active, they found.
Identifying this abnormality led the researchers to look at how the gene behaved in a lab using cells and yeast. By modeling the rearrangement in yeast, they found it appeared to trigger an issue linked with defective sperm production in mammals, they wrote in the study.
Next, they looked at whether infertile males had variants of this gene, working with scientists at the University of Mnster. Compared with the general population, disruptions to SYCP2 were more common in those with fertility problems, the investigators found.
Co-author Samantha Schilit, an expert in unexplained infertility at Harvard Medical School, commented in a statement that these chromosomal problems in infertile men are rarely followed up beyond reporting a higher risk for an issue, which can lead to recurrent miscarriages.
"This work shows that a chromosomal rearrangement may also disrupt or dysregulated genes important in fertility, and therefore should be considered."
Infertility is one of the most common problems among those aged between 20 to 45 years old, affecting between 10 to 15 percent of couples. Evidence suggests doctors are unable to diagnose the source of the problem in between 40 to 72 percent of men. Of those, between 30 to 50 percent of cases are estimated to be caused by genetics, the authors wrote. "Searching for genes involved in unexplained infertility is a rich endeavor," they said.
Co-author Cynthia Morton, a medical geneticist at the Brigham and Women's Hospital, told Newsweek: "This study focuses our interest in chromosomal rearrangements that underlie infertility beyond what is typically presumedthat is, the infertility results from embryos that are chromosomally unbalanced and may lead to miscarriage."
Morton, whose laboratory has had a longstanding interest in structural rearrangements of human chromosomes that underlie clinical disorders, said: "It brings emphasis to the fact that structural rearrangements in chromosomes may contribute to infertility by dysregulating gene expression of genes with a role in gametogenesis," or the creation of sperm.
More work needs to be done to validate the role of SYCP2 male infertility. This would be strengthened by finding more males with genomic variants in SYCP2, she said. The team envisions SYCP2 one day being included in genetic screenings for males to identify the genetic basis of infertility.
"A diagnosis can be therapeutic in itself -- even if there isn't something that can be done to correct it. It ends the search for the underlying issue and opens the door for enrolling in clinical trials," said Morton. "And I believe there is good reason to be optimistic; we now have better tools for discovery and can begin on the path toward therapy."
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A Gene Linked to Male Infertility Has Been Discovered, and It May Account for 50 Percent of Unexplained Cases - Newsweek
Uncovering a defective sperm epigenome that leads to male infertility – Penn: Office of University Communications
One out of eight couples has trouble conceiving, with nearly a quarter of those cases caused by unexplained male infertility. For the past decade, research has linked that infertility to defective sperm that fail to evict proteins called histones from DNA during development. However, the mechanisms behind that eviction and where this is happening in the sperm DNA has remained both controversial and unclear.
Now, researchers atPenn Medicineshow, using newer genome-wide DNA sequencing tools, the precise genetic locations of those retained histones, as well as a key gene regulating it. The findings were published inDevelopmental Cell.
Taking it a step further, the researchers created a new mouse model with a mutated version of the gene,Gcn5, which allows investigators to closely track the defects in sperm from the early stages of sperm development through fertilization and on. This is an important step forward as it could lead to a better understanding of not only infertility in menand ways to potentially reverse itbut also the suspected epigenetic mutations being passed onto the embryo from males either naturally or through in vitro fertilization.
Epigenetics, the factors influencing an organisms genetics that are not encoded in the DNA, play a strong role in sperm and egg formation.
For men who have unexplained infertility, everything may look normal at the doctors: normal semen counts, normal motility. Yet they can still have problems conceiving, says first authorLacey J. Luense, a research associate in the lab of the study's senior author,Shelley L. Berger, the Daniel S. Och University Professor in the departments of Cell and Developmental Biology in the Perelman School of Medicine and Biology in the School of Arts and Sciences, and director of the Penn Epigenetics Institute. One explanation for persistent problems is histones being in the wrong location, which may affect sperm and then early development. Now, we have a really good model to study what happens when you dont get rid of the histones appropriately in the sperm and what that may look like in the embryo.
Read more at Penn Medicine News.
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Uncovering a defective sperm epigenome that leads to male infertility - Penn: Office of University Communications
LA Gets Early Christmas Gift In The Form Of 2 New Mountain Lions, P-78 And P-79 – LAist
Say hello to SoCal's newest mountain lions, P-78 and P-79. (Courtesy, Santa Monica Mountains National Recreation Area/Facebook)
Christmas has come early for Southern California wildlife enthusiasts in the form of two new mountain lions.
On Tuesday, Angela Beatriz Cholo, a ranger with the Santa Monica Mountains National Recreation Area, introduced via Facebook P-78 and P-79 to greater L.A. and to wildlife officials' study of big cats in the region.
Officials found both cats within a day of each other. P-78, a "subadult male," was captured Dec. 11, in the Santa Monica Mountains. P-79, another young male, was spotted and captured in the backyard of a home on Dec. 12.
Both were outfitted with GPS collars and released. P-78 will roam the Santa Monica Mountains, and P-79 will roam the Santa Susana Mountains, according to the Facebook post.
As their designated numbers suggest, P-78 and P-79 are the 78th and 79th mountain lions to join the study overall. Last month, P-77 was captured and tagged in the Santa Monica Mountains. In June, officials captured P-75 in a mobile home park in Pacific Palisades, outfitted her with a tracking collar and released her into the Santa Monica Mountains.
Despite these additions, Southern California's puma population has suffered in recent decades due to habitat loss and inbreeding.
Three big cats were found dead this year. P-53, a 4-year-old female lion, and P-30, a 6-year-old male, had traces of rat poison in their bodies. P-61, a 4-year-old male, died after being hit by a car on the 405 in the Sepulveda Pass area. Researchers think he may have been running from an uncollared puma at the time.
Like her fellow big cats, P-77 has a lot to contend with. There are turf wars with other mountain lions. There's the risk of getting hit by a vehicle while trying to cross freeways, which limit mating opportunities and decrease the genetic diversity of the local mountain lion population. Then there's the risk of mange. Plus, these big cats have to contend with rat poison and other chemicals introduced into the food chain by humans, who are the worst.
Reporter Ryan Fonseca contributed to this story.
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LA Gets Early Christmas Gift In The Form Of 2 New Mountain Lions, P-78 And P-79 - LAist
FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic…
BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Astellas) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV is approved under the FDAs Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. PADCEV is the first FDA approved treatment in the U.S. for these patients. It is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1,3
Metastatic urothelial cancer is an aggressive and devastating disease with limited treatment options, and the approval of PADCEV is a significant advance for these patients who previously had limited options after initial therapies failed, said Jonathan E. Rosenberg, M.D., Medical Oncologist, Chief, Genitourinary Medical Oncology Service, Memorial Sloan Kettering Cancer Center in New York. The PADCEV clinical trial enrolled a range of patients whose cancer was difficult to treat, including those whose disease had spread to the liver.
The FDA approval of PADCEV is welcome news for patients with bladder cancer, said Andrea Maddox-Smith, Chief Executive Officer, Bladder Cancer Advocacy Network. Though new medicines for bladder cancer have been approved in recent years, most people living with advanced stages of this disease face a difficult journey with few treatment options.
This approval underscores our commitment to develop novel medicines that address unmet patient needs, and were grateful to the patients and physicians whose participation led to this outcome, said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas.
PADCEV is the first antibody-drug conjugate approved for patients facing this aggressive disease, and it is the culmination of years of innovative work on this technology, said Roger Dansey, M.D., Chief Medical Officer, Seattle Genetics.
PADCEV was evaluated in the pivotal trial EV-201, a single-arm phase 2 multi-center trial that enrolled 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-based chemotherapy.1 In the study, the primary endpoint of confirmed objective response rate (ORR) was 44 percent per blinded independent central review (55/125; 95% Confidence Interval [CI]: 35.1, 53.2). Among patients treated with the single agent PADCEV, 12 percent (15/125) experienced a complete response, meaning no cancer could be detected at the time of assessment, and 32 percent (40/125) experienced a partial response, meaning a decrease in tumor size or extent of cancer in the body. The median duration of response (DoR), a secondary endpoint, was 7.6 months (95% CI: 6.3, not estimable [NE]). The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). The most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).
The FDA's Accelerated Approval Program allows approval of a medicine based on a surrogate endpoint if the medicine fills an unmet medical need for a serious condition. A global, randomized phase 3 confirmatory clinical trial (EV-301) is underway and is also intended to support global registrations.
About PADCEV
PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1,2 Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). PADCEV is co-developed by Astellas and Seattle Genetics.
PADCEV Support Solutions offers access and reimbursement support to help patients access PADCEV. For more information, go to PADCEV Support Solutions at PADCEVSupportSolutions.com.
About Bladder and Urothelial Cancer
Approximately 80,000 people in the U.S. will be diagnosed with bladder cancer this year.4 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.5
Important Safety Information
Warnings and Precautions
Adverse Reactions
Serious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).
Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).
The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).
Lab Abnormalities
In one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased, hemoglobin decreased, phosphate decreased, lipase increased, sodium decreased, glucose increased, urate increased, neutrophils decreased.
Drug Interactions
Specific Populations
For more information, please see the full Prescribing Information for PADCEV here.
About Seattle Genetics
Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in peoples lives. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en.
About the Seattle Genetics and Astellas Collaboration
Seattle Genetics and Astellas are co-developing PADCEV (enfortumab vedotin) under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.
Seattle Genetics Forward Looking Statements
Certain statements made in this press release are forward looking, such as those, among others, relating to the continued FDA approval of PADCEV (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting; the conduct of an ongoing randomized phase 3 confirmatory clinical trial (EV-301) intended to verify the clinical benefit of PADCEV and support global registrations; and the therapeutic potential of PADCEV including its efficacy, safety and therapeutic uses. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that EV-301 and subsequent clinical trials may fail to establish sufficient efficacy; that adverse events or safety signals may occur; that utilization and adoption of PADCEV by prescribing physicians may be limited by the availability and extent of reimbursement or other factors; and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on managements current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.
1 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.2 Rosenberg JE, ODonnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol 2019;37(29):2592-600.3 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.4 American Society of Clinical Oncology. Bladder cancer: introduction (10-2017). https://www.cancer.net/cancer-types/bladdercancer/introduction. Accessed 05-09-2019.5 National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Cancer stat facts: bladder cancer. https://seer.cancer.gov/statfacts/html/urinb.html. Accessed 05-01-2019.
Waning treatment is a warning for all ‘one-and-done’ therapies – STAT
As a new mother, she didnt know to look for blue-tinged lips. She could just tell her babys color was off. On a chest X-ray, the clean, white-against-dark curves of his ribs were obscured, clouded by fluid. Pneumonia. That tipped Ray Ballards physicians off: He had a form of severe combined immunodeficiency SCID, for short a genetic mutation that hampered the growth of crucial immune cells, leaving him utterly vulnerable to infection.
The best fix was a transplant of his mothers bone marrow. The attitude was that in three to six months, you should be able to go back to normal life, recalled his mom, Barb Ballard.
That was true at least sort of. He got two more booster transplants before he hit 10. An antibiotic left him with hearing loss, and a virus with digestive tract damage. His lack of B cells meant he needed regular injections of other peoples antibodies, and his T cell counts were never ideal. But he was healthy enough to go to public school, to move through the hallways high-fiving half the guys, to slowly inhale and take aim during rifle team practice.
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His T cells had to be working well enough that he wasnt coming down with everything that walked into the classroom, Ballard said.
Then, when Ray was around 18, his immunity began to wane. For him, it came in the form of a norovirus he couldnt shake. For others with the same rare disease, it appears as pneumonia or gastrointestinal trouble or an unexpected T cell decline. Over the last 10 years, the trend has become increasingly clear: The bone marrow transplants that kept certain babies with SCID alive sometimes stop working after years or decades of providing fairly reliable immune defenses.
Now, to patient advocates, this has become an urgent lesson in the language people use to talk about treatment and not just for SCID. They see their communitys experience as a cautionary tale for anyone developing or receiving a therapy thats marketed as potentially curative.
Theres an expectation and a hope: When they hear about bone marrow transplants, it sounds like a lifetime deal, a forever fix, said John Boyle, president and CEO of the Immune Deficiency Foundation. Weve discovered, as a result of this issue, that bone marrow transplant ended up not being the forever fix we thought it was.
Experts have known for years that some of these transplants wouldnt provide full immune protection over the course of a SCID patients entire life. They say clinicians should have avoided the word cure. But even scientific papers that hinted at such complications called the treatment curative. Just this year, an Immune Deficiency Foundation employee was given the unenviable task of sifting through the organizations thousands of pages of online material, scrubbing out every cure that popped up. It was only there a handful of times sometimes in quotes from clinicians, Boyle said but it was there and it needed to be removed.
The language patients hear can sometimes even change their outcomes. Weve heard of cases where, years later, they realized their immune system isnt as healthy as they thought, but nobody was tracking that because they hadnt maintained a relationship with the physician, or the physician didnt maintain a relationship with them, explained Ballard. The word cure, it gives them a false sense of security.
At a time when seemingly every biotech is promoting the idea of one-and-done therapies and setting prices accordingly these advocates hope companies, too, will be more wary. One of the things Im trying to make them very aware of is the need for lifelong follow-up, said Heather Smith, who runs the SCID Angels for Life foundation. For her, its personal: This summer, her son took part in a clinical trial for a gene therapy in the hope that it would provide the immune protection that his decades-old bone marrow transplant no longer could. My son will be followed for 15 years, she said. But what about after that?
Part of the issue with bone marrow transplants from one person to another is the natural genetic variation between us, particularly in the proteins that help our bodies distinguish its own cells from foreign ones. Receiving cells from someone whose proteins dont match yours could cause a civil war within you. Thats why bone marrow transplants began back in the 1950s with identical twins: Sharing those genes meant increasing the likelihood of harmony between the body and the graft.
But the vast majority of people dont have a protein-matched sibling, let alone an identical twin. So researchers set about figuring out how to transplant bone marrow from a parent to a child in spite of only sharing half of their genes and from a matched unrelated donor to a stranger. Like cooks intent on refining recipes to their taste, the doctors who adapted the technique for SCID often did so slightly differently from one another. Over the past 35 years, those idiosyncrasies have hardened into habits. Right now, everybody transplants their patients their way, said Dr. Sung-Yun Pai, an immune deficiency researcher and co-director of the gene therapy program at Boston Childrens Hospital.
Perhaps the most vociferous controversy has been about whether to use chemotherapy to wipe out the existing stem cells within a recipients bone marrow to make room for the donors. The doctors who do use chemo before a transplant might prescribe different doses; others forego it entirely.
The arguments were sound on both sides. On the one hand, the toxic drugs could clean out the niches within our bone and increase the chances that the donors cells take root. On the other, these chemicals could hamper growth, brain development, and fertility, could make an infant who was already sick even sicker, and could increase the likelihood of certain cancers later in life. Its like being exposed to a bunch of X-rays and sunlight, or other DNA-damaging agents, Pai explained.
Because SCID is so rare the most common subtype is thought to occur in 1 out of every 50,000 to 100,000 newborns and because every hospital was doing transplants slightly differently, it was hard for physicians to systematically study what was working best. But even early on, they could tell that some of the infants whod gotten no chemo were developing incomplete immune systems. They didnt produce their own B cells, for instance, and so needed regular injections of antibodies collected from other peoples blood.
In healthy infants, stem cells migrate from the crevices of the skeleton to an organ in the chest called the thymus, where theyre trained to become T cells. In these infants, the T cell counts grew after transplant but it wasnt necessarily because the sludge was securely taking hold in the niches of their bones. Rather, immunologists say, the donors progenitor cells were only transient. Some were able to head toward the thymus for schooling. Some graduated and started fighting off infections. But as those populations were depleted with age, there werent robust reserves of stem cells in the bone marrow that could arrive to produce more. To Pai, its like trying to fill a kindergarten class in a neighborhood where no ones having babies.
You and I continue to have a slow trickle of new T cells coming out, said Dr. Harry Malech, a senior investigator at the National Institutes of Health, who sits on the board of a gene therapy company, Orchard Therapeutics (ORTX), but does not receive any financial compensation. Instead of a torrent becoming slower, in these patients it goes from a trickle to practically nothing.
Thats why immunity starts to wane in kids like Ray Ballard. To many immunologists, it isnt a surprise, though they still arent sure why chemo-less transplants last longer for some of these kids than others. They can also understand how some families and clinicians might have viewed this treatment as a lifetime fix.
As Malech put it, If I said to you, Your child, instead of dying in infancy, will likely get to adulthood, go to school, have a normal life, you might think the word cure in your mind.
Even for parents who knew the protection might not last forever, the failure of a long-ago bone marrow transplant puts them in a bind. If they do nothing, their child will once again be vulnerable to any passing infection, which could prove fatal. They can try another round of the same procedure, though booster transplants sometimes come with added complications. Or they can try getting their child into a research trial for gene therapy, which comes with the risks of any experimental treatment.
Some feel an irrational guilt when the bone marrow they donated to their child stops functioning. Its your cells, and if it doesnt work, you failed them, said Ballard, who lives in Clifton, Va., about a 40-minute drive from Washington, D.C. Her son Ray had already had three transplants as a child. When his immune system started to fail again in early adulthood, gene therapy at the NIH seemed like the only reasonable choice.
That would involve researchers removing cells from his bone marrow, using an engineered virus as a kind of molecular syringe to slip in a healthy copy of the gene in which he had a defect, and then threading these corrected cells back into his veins a bone marrow transplant to himself. But preparing a virus can be tricky, and there were delays.
Meanwhile, Rays condition was getting worse. His norovirus was preventing him from absorbing much nutrition, and as Ballard put it, his bone structure was just crumbling at that point. His doctors told her he had the skeleton of an 85-year-old.
He died this past February, at 25 years old. One friend got his birth and death dates tattooed onto her shoulder. Another painted a portrait of him for Ballard, in which his arms are crossed, his lips pressed together in a wry smile.
At Boston Childrens, Pai is now helping to lead a randomized trial to better understand what dose of chemo works best for SCID patients receiving transplants. Over the last decade or so, she, Malech, and many other clinicians have also teamed up to track the long-term results of immune deficient patients whove received someone elses bone marrow.
Pai is hopeful that knowing about the phenomenon of waning immunity will give gene therapies a better shot at becoming a durable fix. They probably have a better chance of achieving a one-time, lifelong cure, but its never wrong to be humble, she said. Only after decades more and hundreds or thousands of patients will we know for sure.
Patient advocates point out that even then, these patients will still have the capacity of passing on their SCID-causing gene to future generations, and so the word cure is overly optimistic. Thats why I like the word remission, said Smith. That still gives you the hope. If you were given a cancer diagnosis, you wouldnt go through treatment and then just forget about it for the rest of your life.
As Boyle put it, Weve seen the promise and then weve seen the reality. Everyone who is looking at a transformational therapy should be optimistic, but also realistic, and not assume that this is truly one and done. (Boyles foundation has received financial support from Orchard Therapeutics, which is developing a gene therapy for a form of SCID.)
To Amy Saada, of South Windsor, Conn., that isnt theoretical. Her son Adam is now 12, and the immunity from the bone marrow transplant he got as a baby is wearing off. He isnt yet sick, but his parents know they need to decide between gene therapy or another transplant soon. She has a very clear memory of how long and uncertain the recovery from treatment felt. In some ways, she wishes she didnt know quite as much as she does; that way, she would feel less trepidation about what lies ahead.
Your heart kind of sinks, she said. Youve already been through it once, and it was hell. Its harder the second time.
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Waning treatment is a warning for all 'one-and-done' therapies - STAT
Better Success Rates of IVF Treatments – Health Files by Dr Firuza R. Parikh – ETHealthworld.com
The last few decades have seen revolutionary developments in the field of Assisted Reproduction. IVF is over 40 years old. It took hundreds of experiments on animal and human eggs and sperm before Louise Brown was born in Oldham, the UK in 1978. Scientific advancement calls for a healthy interaction of colleagues, scientific bodies and the media.
After much discourse, IVF received scientific and societal acceptance ultimately resulting in the Nobel Prize for Bob Edwards in Medicine or Physiology in 2010 for work leading to the birth of Louise Brown. However, scientific ignorance can thwart major discoveries. Dr Subash Mukhopadhyay created Indias first and the worlds second test-tube baby. Durga was born just 67 days after Louise Brown. The scientific climate did not allow Dr Mukhopadhyay his claim to fame. This resulted in a crushing halt to the spread of ART in India for almost a decade.
The earlier decades saw a plateau in success rates with IVF techniques. Several factors have made IVF a household name making it the standard of care for many infertile conditions.
The introduction of the hormones like LH (Luteinizing Hormone) & FSH (Follicle-stimulating Hormone) to bring about the formation of multiple eggs was a major step to improving success, as there were more eggs and embryos to choose from. Besides, efforts were made to better understand the microenvironment of the embryo. This resulted in nutrient medium satisfying the need for embryos at various stages of development thereby enhancing pregnancy rates.
A major breakthrough occurred for males with very low or no sperm counts, with the introduction of Intracytoplasmic Sperm Injection in 1992 by Dr Palermo & Dr Andre van Steirtegheim in Brussels. This caused a major paradigm shift in treating male infertility. In 1994, our team created Luv Singh the first ICSI baby in South-East Asia. The technique gave a major boost to the success of Assisted Reproduction in India.
The early 90s saw an interest in looking at genetic disorders in couples who were otherwise fertile. Handyside & his group described pregnancies after biopsy of human preimplantation embryos in cases of sex-linked diseases. Techniques were refined over the years so that instead of only 5 chromosomes being checked, today we have the ability not only to check for all 46 chromosomes but to also detect minor variations in the structure and placement of chromosomes by powerful platforms like Next Generation Sequencing.
The technique of Pre Implantation Genetic Testing (PGT) also applies to couples with inheritable mutations for genetic diseases like Thalassemia, Sickle Cell Disease, Duchennes Muscular Dystrophy, and Huntingtons Chorea. This technology has been a boon for couples who would otherwise be at risk of having a genetically compromised baby.
There has been a constant endeavour to enhance pregnancy rates for couples facing fertility issues. The endometrium i.e. the inner lining of the uterus may sometimes be ineffective in helping the process of implantation. We devised a co-culture technique called Cumulus Aided Transfer (CAT) for the first time in the world, in which cells surrounding the oocyte (Cumulus Cells), are used as a feeder layer on which the embryos can grow. This has resulted in better pregnancy chances.
Immunological competence and its vagaries are now better understood. Modulating the womans immune system can prevent the block from implantation.
Today we are witnessing diminishing fertility potential globally due to the presence of different types of pollution affecting the ovaries and testes, thus decreasing egg and sperm counts prematurely. Our team has successfully carried out Ovarian Rejuvenation by instilling Platelet Rich Plasma in the ovaries of such women.
DISCLAIMER: The views expressed are solely of the author and ETHealthworld.com does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person/organisation directly or indirectly.
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Better Success Rates of IVF Treatments - Health Files by Dr Firuza R. Parikh - ETHealthworld.com
Inga was a beautiful girl with her whole life in front of her, her death was a national shame – Belfast Newsletter
It remains one of Northern Irelands most notorious cold-cases, still unsolved after 31 years.
It was in April, 1988 when a pretty young blonde schoolgirl from Munich named Inga Maria Hauser, a budding singer with intrepid spirit to match, decided to go backbacking during the Easter break, and full of the anticipation of adventure, primed to see something of other countries and cultures, she set out to visit England, Scotland and Ireland.
Her friend Walter Schreiner, who first met Inga in their local youth club in the mid-1980s, said of the budding young adult: Every person who knew her loved her. She was always smiling, she was always shining and was very intelligent.
A girl with charm and wit and all before her then, setting off to see new sights and meet new people in a different culture to her own; a brave soul, unfazed by the prospect of travelling alone.
Poignantly, Inga had already noted the friendliness of the local people.
During her travels one of the 18-year-olds postcards home from England said: The people here are so helpful and lovely that I cant imagine anything bad could happen to me.
A note in her diary added: The day after tomorrow I am going on to Ireland. Im looking forward to that the best.
She got the ferry from Stranraer, arriving in the port town of Larne on April 6. But she would never make it to her next destinations of Belfast and then Dublin.
Two weeks after she was last seen alive, her dumped mutilated body, having, acorrding to Police, been subjected to a vicious and ruthless sexual and physical assault, was found by a sheep farmer in a remote part of Ballypatrick Forest near Ballycastle.
Here was the life of a beautiful girl cut senselessly short, her dreams and hopes for the future callously denied and a family back in Germany plunged into unimaginable grief.
In the 31 years since the horrific murder both of Ingas distraught parents have died without seeing justice served.
Her mother Almut passed away in October of this year. Her father, Josef, died in 2006 from cancer. Both were hearbroken that the case was never solved; that they were denied answers, a perpetrator or perpetrators brought to justice.
Ingas sister Frederika was particularly badly affected by her sisters death, her son Viktor told a BBC programme last year:
Siblings always have a little tension around them. But they were really close, even though they were quite different. There is a German saying - ein Herz und eine Seele - one heart, one soul.
Of the pursuit of justice for Inga, Viktor said: It would be especially important for my mother. I hope if the murderer gets caught, my mother can finally leave this behind and we can be free of this curse.
SDLP MLA for East Londonderry John Dallat has been involved in the campaign to find Inga Maria Hausers killer for many years; for him the quest to find those responsible for Ingas death has become a life-long priority and passion project.
He was instrumental in getting the case reopened by the PSNI last year after the files were closed due to lack of progress.
John said: I remember when Inga was murdered and my heart went out to her family. I was a young father then to a young girl who I hoped would grow up also and travel the world - and she did. Every parent expects their child to be able to travel without being murdered in the brutal way that Inga Maria was. After ten years of campaigning the parents said they werent coming back and so I assumed that role fighting for justice for Inga. And it has been a long struggle.
This is a personal and emotional struggle for me and it has been a great privilege getting to know Ingas only sister Frederike Leibel. She has one son, Victor, who visited last year, and stayed with us.
In all the years since Inga was murdered they only received a series of letters in English and werent even aware for a long time that they were entitled to legal representation. The support they received was not good.
But we want to focus on getting whoever did this heinous crime to be brought to justice.
Since a memorial stone to Inga was erected in Ballypatrick Forest Park on the 30th year of her death, well-wishers have left tokens at the site, flowers, soft toys, cards, religious objects.
This week John Dallats granddaughter Caitlin laid a wreath at the headstone to mark 31 years. The hope is to send the Hauser family a festive message of support - that their beloved sister and aunt has not been forgotten; the difficult quest for answers continues.
The also plan to erect a German flag to acknowledge Ingas home country and to signify that she was the only international student to die here in Ulster during the Troubles.
Christmas means nothing to the Hauser family since they lost their beloved Inga in one of the most brutal murders ever recorded and all the more reason why we need to show that we really care, continues John.
The family know that Inga hasnt been forgotten and they have recovered hope that justice may still be done.
In May last year, a 59-year-old man was arrested on suspicion of the murder by police investigating the case and later released on bail pending further inquiries.
Detectives said they believe several people may have been involved directly in the murder, or in the subsequent cover-up, and said they only need fractional piece of evidence to bring the chief suspects to justice.
Police also found a male genetic profile at the murder scene, although have yet to find a match.
The Public Prosecution Service is now in receipt of a lengthy file of evidence against the chief suspect.
Dallat continued: The fact that a file has gone to the Public Prosecution Service after 31 years is welcome news and offers some hope to the Hauser Family.
It represents the first chink of light in a long struggle for justice for their daughter Inga who died a most brutal death at the hands of a killer who was intent on raping a young girl over here during a school break to find out about a country that her parents loved.
Perhaps the saddest thing about the murder of Inga is the silence of those who know who did it, but that silence cannot be sustained for much longer.
Hopefully the file which has gone to the Public Prosecution Service will be a historical development which will bring closure to a family who have suffered in silence for far too long, Mr Dallat added.
It is our responsibility and that of the police and courts to redouble our efforts to ensure that those involved in Ingas murder are brought to justice.
I am so sorry that my efforts and that of others havent achieved their purpose so far.
But I remain confident that sooner, rather than later, that justice will be done and that the retribution Almut and Josef were denied will be delivered.
Dallat is clear about what he would like to say to those responsible for, or who know something about, Ingas murder:
I urge them to admit their guilt. Its not easy to give evidence against people who were perhaps once friends. But we believe there are witnesses out there who must do the right thing and demonstrate some level of decency.
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Inga was a beautiful girl with her whole life in front of her, her death was a national shame - Belfast Newsletter
The Unbeatable Holiday Gift: Save $70 on a 23andMe Health + Ancestry Kit Today – Men’s Journal
Mens Journal aims to feature only the best products and services. We update when possible, but deals expire and prices can change. If you buy something via one of our links, we may earn a commission.Questions? Reach us at shop@mensjournal.com.
Have you finished your holiday shopping yet? Sometimes, the hardest people to buy for are your significant other, or those closest to you. Theres always that one big gift you know they want, the one youre sure to givebut what comes next? Sure, you could load up on stocking stuffers, or settle for gift cards. But heres a better idea: Give the gift of health, knowledge, and insight. Give them a 23andMe Health + Ancestry Kit.
The 23andMe Health + Ancestry Kit ($129; was $199) is full of fascinating information on ancestry and family lineage. But it also provides a wealth of biological and genetic insight to help your loved one live a happier, healthier life.
DNA home test kits are all the rage, and with good reason. Its fun to trace your lineage, to track where your ancestors came from, and how you got where you are today. Thats why these kits are so popularespecially this time of year.
Holiday gatherings can be a slog. But sharing ancestral info with family and loved ones is a fantastic conversation piece. Showing up at the family get-together with a family tree, with names, dates, and places of those who came before, is definitely fascinating and fun. But for the seniors in your family, it can be far more than that.
If youve ever watched your grandmother or grandfather reminisce about the old days, you know what we mean. Imagine the faces of the seniors in your family lighting up when you remind them of places and people in the past, of memories theyd forgotten and people theyve missed.
Reminiscing about old times, reliving memories of ancestors passed on, of homes and towns they once adoredor hated!is sure to bring a smile to everyone gathered around the holiday table. Its sure to be a heart-rending, emotional moment. And it will make this holiday season one you, and they, will cherish for the rest of your lives.
Thats why the 23andMe Health + Ancestry Kit makes an unbeatable gift. And right now, you can save $70! Regularly $199, through December 26 you can pick one up for just $129. Thats only $30 more than the Ancestry + Traits kit alone. Thats a 23andMe December deal you cant pass up!
23andMes Health + Ancestry Kit goes deeper than just lineage and genetic traits, though. It provides insight and useful information about health and biological makeup. Your loved one will get more than 150 personalized reports that break down genetic data, the science, and potential next steps to living a healthier life.
Theyll learn how their DNA could affect their chances of developing certain health conditions like Type 2 diabetes*. Theyll find out how their DNA relates to their lifestyle, like muscle composition, diet, and sleep. Particularly valuable is the Carrier Status test, which will let them know if their DNA indicates they may be a carrier for genetic variants linked to certain inherited health conditions.
Of course, the 23andMe Health + Ancestry Kit has the Relative Finder, the Family Tree, and the Ancestry Reports that are so fun and fascinating to share at the holidays. But the valuable information from the more than 150 Trait, Health Predisposition, and Carrier Status reports goes far beyond fun and fascination. Its the kind of knowledge that can help your loved one live a fuller, healthier life. Thats the kind of holiday gift no stocking-stuffer or gift card can possibly beat.
During this 23andMe December deal, youll save $70!
*Customers have the option to choose whether to access their health reports. Visit [https://www.23andme.com/test-info/] for more important test information.
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The Unbeatable Holiday Gift: Save $70 on a 23andMe Health + Ancestry Kit Today - Men's Journal
Norway’s government to review North Sea Balder Future proposals – Offshore Oil and Gas Magazine
The `Balder Future project will involve drilling 13 new production wells and one new water injector on the Balder field.
Courtesy Vr Energi
Offshore staff
SANDNES, Norway Vr Energi has submitted its plan to extend production from the Balder and Ringhorne area in the North Sea to 2045.
Norways Ministry of Petroleum and Energy will review the revised proposals for the `Balder Future project, which will involve drilling 13 new production wells and one new water injector on the Balder field to recover an additional 136 MMboe, and extending the lifetime of the Jotun A FPSO.
The Balder field is in license PL 001. According to Var, the NOK19.6-billion ($2.17-bilion) project should create almost 30,000 man-years of work through 2045.
In addition, the company and partner Mime Petroleum plan to drill subsea infill wells and new wells from the neighboring Ringhorne platform, and Vr may undertake further exploration drilling in the area, which could boost the resource further. All these activities will take place while production continues at the Balder and Ringhorne fields.
Earlier this year, Vr awarded an EPCI contract to Rosenberg Worley in Stavanger for the FPSO life extension works. The vessel will be taken off-station and removed to the shore in mid-2020 for the upgrade program, then reinstalled during summer 2022 at a location in between the two fields.
Baker Hughes and Ocean Installer in Stavanger, will engineer, procure, construct and install new subsea production systems, umbilicals, risers and flowlines for Jotun A.
12/17/2019
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Norway's government to review North Sea Balder Future proposals - Offshore Oil and Gas Magazine
Bill To Create White Sands National Park Heads To Trump For Signature – KRWG
Today, U.S. Senator Martin Heinrich (D-N.M.) voted for the final passage of the National Defense Authorization Act for Fiscal Year 2020. Here is a statement from Senator Heinrich's office:
Heinrich, a member of the Senate Armed Services Committee and Ranking Member of the Strategic Forces Subcommittee, authored a number of provisions in the bill to strengthen New Mexico's military installations, national laboratories, economic development, and leadership in the future of technologies like Artificial Intelligence, directed energy, and space. The NDAA also included language Heinrich authored to designate White Sands National Park in southern New Mexico and complete a land exchange between the Army and the National Park Service.
This bill makes major investments to ensure our Armed Forces are equipped with the most modern technology so we can stay ahead of our adversariessaid Heinrich.New Mexico is the Center of Excellence for small satellites and for directed energy weapons, and this bill increases funding and streamlines authorities to bolster those missions. I am proud to have authorized funding for military construction projects that will modernize infrastructure at Holloman Air Force Base, White Sands Missile Range, and Kirtland Air Force Base. This bill also makes major reforms to fix the military housing crisis and takes meaningful action on contamination at dairies outside Cannon Air Force Base. These provisions, among many others, help New Mexico families, benefit our economy, and further New Mexico's strong position as a leader in national security for years to come.
As the co-founder of the Senate Artificial Intelligence Caucus, Heinrich added, "I am also proud to have incorporated language from the Armed Forces Digital Advantage Act to modernize defense workforces with digital engineers, specialized in computer science, and to have increased funding for the future of Artificial Intelligence.
The NDAA sets the Department of Defense spending levels and policies for the upcoming fiscal year and authorizes funding for the Department of Energy's nuclear weapons programs at Sandia and Los Alamos National Laboratories, as well as the Department of Energy's environmental cleanup programs including the Waste Isolation Pilot Plant (WIPP). The Senate will soon vote on a number of appropriations bills that set the funding levels for agencies.
A list of many of the programs and provisions Senator Heinrich advocated for during the bill writing process that were included in the FY20 NDAA is available as a PDFHEREand below.
New Mexico Military Construction Projects
Kirtland Air Force Base
Senator Heinrich secured $15.5 million for the construction of a Combat Rescue Helicopter Simulator Facility at Kirtland Air Force Base. This facility will house new HH-60W simulators, training spaces, and equipment used by the 58th Special Operations Wing to train new students. This construction will allow for a seamless transition from the HH-60G legacy aircraft to the new HH-60W and provide continuous Programmed Flight Training for its operators.
Senator Heinrich secured $22.4 million for the construction of a UH-1 Replacement Facility at Kirtland Air Force Base. This facility will house new simulators used for training flight crew personnel in the UH-1 replacement aircraft set for delivery to the 58th Special Operations Wing starting at the end of FY 2022. This construction will allow for an on-time delivery of the simulators, and critical training in the new aircraft.
Holloman Air Force Base
Senator Heinrich secured $20 million for the construction of a climate-controlled, storage and shipment facility at Holloman Air Force Base. The facility will be used to store, inspect, and prepare the movement of military support equipment and provide maximum protection of our expeditionary, warfighting resources. This will enable assets to be maintained in a constant state of readiness and postured for worldwide deployment with greatly reduced maintenance costs. The use of this facility will save the government $800,000 annually for the maintenance and/or replacement of these assets by preserving the shelf-life of items otherwise stored in the open as well as save $120,000 a year in replacement costs of shipping containers damaged by exposure to weather.
White Sands Missile Range (WSMR)
Senator Heinrich secured $5.8 million to build a microgrid at White Sands. The microgrid will utilize a solar array, natural gas generator, and lithium ion battery system to power water wells to provide an uninterrupted water supply to WSMR. Currently, the wells are connected in such a way that leaves them susceptible to power outages that could leave WSMR without drinkable potable water. This microgrid system will ensure a reliable supply of water for the installation.
White Sands Missile Range Land Enhancements and White Sands National Park
White Sands Missile Range Land Enhancements and White Sands National Park
The Senate Armed Services Committee adopted an amendment by Senator Heinrich that incorporates legislation to finalize updated land exchanges between the Department of the Interior and the Department of the Army that have been pending since the 1970s. The exchange of parcels between White Sands National Monument and White Sands Missile Range will clean up boundary anomalies, transfer important missile range infrastructure to the jurisdiction of the Army, and provide increased opportunities for visitors at the National Monument. The bill was developed in close consultation with the Army, the Air Force, the National Park Service, local elected officials, neighboring tribes, and local residents.
New Mexicos National Laboratories and WIPP
Los Alamos National Laboratorys Plutonium Mission
Senator Heinrich again secured full funding authorization to maintain Los Alamos National Laboratorys (LANL) role as the nations Center of Excellence for Plutonium Research. The bill authorizes $551 million for LANLs ongoing plutonium research and pit production programs. The funding supports personnel, equipment and other activities at LANL to meet pit production requirements by 2026; highlights include, $232 million for plutonium operations, $21 million to support pit production, $10.5 million for fire suppression upgrades in PF-4, $16 million for power and communications improvements and $168 million for construction related to replacing the outdated Chemistry and Metallurgy Research (CMR) building at LANL.
Defense Nuclear Facilities Safety Board
Senator Heinrich supported provisions in the bill that direct the Department of Energy (DOE) to allow the onsite safety inspectors from the Defense Nuclear Facilities Safety Board (DNFSB) full access to all defense nuclear facilities at LANL, Sandia National Laboratories and WIPP. The bill also ensures access to all required documents and reinforces the boards role protecting both the general public as well as onsite employees and contractors. Senator Heinrich supported these provisions in response to an order DOE issued in May 2018 that attempted to limit the boards access and role in protecting health and safety. Congress created the DNFSB in 1988 to provide oversight of public health and safety at the defense nuclear facilities managed by the Department of Energy.
National Nuclear Security Administration (NNSA) Laboratory Directed Research and Development (LDRD)
Senator Heinrich secured a provision extending for one year an exemption from an administrative overhead burden on NNSA labs for LDRD that would double-tax Sandia National Laboratories and Los Alamos National Laboratory. LDRD is a strategic research and development program that is critical to maintaining the scientific vitality of the national laboratories. The bill continues the suspension of the overhead burden through fiscal year 2021.
National Laboratory Funding
Senator Heinrich supported full funding authorization for the National Nuclear Security Administrations (NNSA) nuclear weapons programs. Within NNSAs funding, Senator Heinrich secured full funding of $2.1 billion to continue the Life Extension Programs supported by Sandia and Los Alamos National Laboratories. This increase of $197 million over FY19 will maintain the existing weapons stockpile and assure safety and security.
Los Alamos National Laboratory (LANL) Environmental Cleanup
The bill authorizes the presidents request of $195.5 million for soil and water remediation and removal of radioactive waste. Funding is included again this year to address the hexavalent chromium and Royal Demolition eXplosive (RDX) plumes in groundwater in Los Alamos. Senator Heinrich will work now with the Appropriations Committee to increase the funding for fiscal year 2020 to $220 million, the same level as the last fiscal year.
Waste Isolation Pilot Plant (WIPP)
The bill authorizes full funding of $398 million to operate the Waste Isolation Pilot Plant (WIPP), including $17.5 million to repair and replace degraded facility structures, systems, and components, $58 million to continue construction of additional ventilation for the mine and $34.5 million for a new utility shaft.
New Mexicos Defense R&D Labs, Test Ranges, and Industry
U.S. Department of Defense (DoD) Mentor-Protg Program
The bill re-authorizes the DoDs Mentor Protg Program (MPP), which is the oldest continuously operating federal mentor-protg program in existence, through 2026. Originally established in 1991, the MPP helps eligible small businesses expand their footprint in the defense industrial base. Under the MPP, small businesses are partnered with larger companies. In the past five years, DoDs MPP has successfully helped more than 190 small businesses fill unique niches and become part of the militarys supply chain. Senator Heinrich ensured the survival of the MPP when it faced expiration, and salvaged this influential, small-business focused program.
Directed Energy Test Range Workloads
Senator Heinrich secured $15 million for White Sands Missile Range in order to accommodate the increase in directed energy testing workloads to accommodate the increased demand in the 21st century. A lack of funding for increased directed energy testing is a serious issue; especially, given the workload and number of directed energy demonstrations and exercises have increased significantly since 1975. The projected workload for fiscal years 20182022 for the High Energy Laser Systems Test Facility at White Sands is large and growing, and has expanded to include high-powered microwave testing. Yet, funding remained at the same level. Senator Heinrich secured the funds necessary to meet the growing demand and support the appropriate test workloads.
3-D Printed Electronics Army Innovation Hub for Next Generation Additive Manufacturing
Senator Heinrich secured an additional $2 million for additive manufacturing (AM), which is already making innovative technological leaps that could yield major advances in more lethal and longer-ranged fires. New Mexico Tech and the University of Texas at El Paso are leading entities in 3-D printing. This technology can combine existing and new materials into 3-D printed circuit architectures, producing smarter, lighter, and denser constructs to enable projectiles to double current ranges while achieving higher precision.
STARBASE
Senator Heinrich helped secured an additional $30 million for the STARBASE program. This program is meant to improve the knowledge and skills of students in kindergarten through 12th grade in science, technology, engineering, and math (STEM) subjects, to connect them to the military, and to motivate them to explore STEM and possible military careers as they continue their education. STARBASE is a highly effective program run by our dedicated servicemembers and strengthens the relationships between the military, communities, and local school districts. STARBASE currently operates at 76 locations in 40 states, the District of Columbia, and Puerto Rico, primarily on military installations. New Mexico is one of those locations. Since its inception in 1991, over 825,000 students have benefitted from the STARBASE program, including 45,000 last year.
New Mexico Space Missions
Department of Defense Launch Support and Infrastructure Program for Small-Class and Medium-Class Payloads
The bill authorizes a provision championed by Senator Heinrich that enables the Secretary of Defense to carry out a program to enhance infrastructure and improve support activities for the processing and launch of Department of Defense (DoD) small-class and medium-class payloads.
Spaceport America in New Mexico is a licensed inland spaceport that provides surface-to-space open sky launches landing in restricted flight zones. The New Mexico Spaceport is located next to White Sands Missile Range (WSMR) where the DoD controls the only restricted air space in the entire country besides the White House.
Hypersonic and Ballistic Tracking Space Sensor
In an effort to develop a reliable defense against cruise missiles and hypersonic weapons, Senator Heinrich and Senator Deb Fischer (R-Neb.) added $108 million for a hypersonic and ballistic tracking space sensor that will help correlate data and track the incoming target for intercept. Senator Heinrich crafted language to help prioritize this capability gap and increased funding.
Space Rapid Capabilities Office (Sp-RCO)
The bill authorized nearly $24 million for the Space Rapid Capabilities Office (Sp-RCO) which is housed at Kirtland Air Force Base. As Ranking Member of the Strategic Forces Subcommittee, Senator Heinrich has fought to ensure New Mexico remains the small satellite center of excellence for the military. Senator Heinrich recently announced plans for the establishment of additional classified workspace, near Sp-RCO, that can be used by potential commercial partners to facilitate the rapid fielding of new space capabilities.
Space Test Program (STP)
The conferenced bill authorized $26.09 million for the Space Test Program (STP) which is housed at Kirtland Air Force Base. As Ranking Member of the Strategic Forces Subcommittee, Senator Heinrich has strongly supported STPs mission to secure launches for experimental spacecraft from emerging entrants including Rocket Lab or Vox Space that are smaller and far less expensive than traditional military satellites that are launched aboard larger rockets under the National Security Space Launch program. Senator Heinrich included provisions elsewhere in the bill to establish a program to improve infrastructure and launch support at FAA licensed spaceports. Since 1965, the STP has conducted space test missions for the purpose of accelerating Department of Defense space technology transformation while lowering developmental risk.
Rocket Systems Launch Program
The bill authorized $13.19 million for the Rocket Systems Launch Program (RSLP) which is housed at Kirtland Air Force Base. Senator Heinrich supports the Rapid Agile Launch Initiative which seeks to award launch service agreements with non-traditional, venture-class companies.
Artificial Intelligence
Armed Forces Digital Advantage Act
The NDAA incorporates important provisions taken from Senator Heinrichs Armed Forces Digital Advantage Act. These provisions recognize the importance of individuals with aptitude and experience in digital expertise and software development to the armed services and requires Secretary of Defense to devise an implementation plan to recruit and develop digital engineering specialists. The bill also requires the Defense Secretary to create a digital engineering capability for the development and deployment of acquisition programs and software support. The bill also requires a demonstration of digital engineering capabilities and policy guidance to promote the use of said capabilities.
National Security Commission on Artificial Intelligence Extension of Authority
The bill includes a provision supported by Senator Heinrich that extends the duration of the current Artificial Intelligence Commission in order to account for time lost due to the government shutdown earlier this year.
New Mexico Military Housing Reform and Contamination Cleanup
Military Housing Reform
The bill includes a provision championed by Senator Heinrich that establishes a uniform code of basic housing standards and requires inspections to ensure compliance. This uniform code provides for safety, comfort, and habitability for military housing units and ensures the inspection of such units adhere to this standard. This is a critical step in addressing the problems associated with military housing around the world and ensuring our service members and their families live in the healthy dwellings they deserve.
Perfluorooctanesulfonic acid (PFOS) and Perfluorooctanoic acid (PFOA) Contamination Cleanup
Senator Heinrich included provisions from H.R. 1567 or the PFAS Damages Act, to provide relief to communities and businesses impacted by PFAS contamination in groundwater around Air Force bases in New Mexico and across the country, including dairy farms in New Mexico that have been upended by PFAS contamination from nearby Cannon Air Force Base.
This measure will ensure that the Department of Defense (DOD) takes precautionary action to prevent human exposure, including through agricultural products, provide alternative water or water treatment for contaminated agricultural water, and acquire contiguous property that is contaminated. The measure will also mandate that the Department of Defense (DOD) create a plan of action to clean up contaminated sites nationwide and take all necessary steps to prevent further risks to public health.
New Mexico Military Energy Resilience
Military Environmental Research Programs
The bill includes a requirement supported by Senator Heinrich and Senator Angus King (I-Maine) that would direct no less than $10 million be directed toward the development and demonstration of long-duration, on-site battery storage for distributed energy applications, $10 million for development, demonstration and validation of secure microgrids for both installations and forward operating bases, $10 million for development, demonstration, and validation of non-fluorine based firefighting foam and $5 million for development, demonstration, and validation of technologies that can harvest potable water from air.
Additional Priority Provisions
Federal Employee Paid Leave
The FY20 NDAA for the first time provides all federal employees with 12 weeks of paid leave including for the birth, adoption, or fostering of a new child. The bill also allows 12 weeks of paid leave for the care of close family members, serious employee health conditions, and for circumstances that arise when the employee or a family member is detailed for covered duty in the armed forces. Paid family leave supports federal employees and their family commitments and provides benefits necessary to recruit and retain the talent that is essential for federal agencies to carry out their mission to serve the nation. The federal government is the nation's largest employer, with more than 2 million employees. This provision ensures that our federal workforce will no longer face the impossible choice of caring for their health and family, or receiving pay.
Eliminating the Widows Tax
The FY20 NDAA mandates a 3-year phase out of the so-called widows tax, which required that surviving spouses of deceased military members forfeit part or all of their Department of Defense Survivor Benefit Plan (SBP) annuity when they receive Dependency and Indemnity Compensation (DIC) from the Department of Veterans Affairs. More than 60,000 surviving families are negatively impacted by the Widows Tax, which reduces surviving spouses' benefits by an average of $924 per month, or $11,000 annually. This action by Congress will ensure that widows and widowers of a deceased active-duty service member or retiree who died of a service-related cause receive full annuity payments.
Addressing and Stopping the Flow of Synthetic Opioids to the United States
The bill includes provisions that will hold foreign countries accountable for their pledges to go after those who produce and traffic fentanyl and other synthetic opioids. Specifically, the NDAA will give the U.S. federal government the ability to apply economic and other financial sanctions to illicit traffickers from China, Mexico, and other countries of concern. The FY20 NDAA also establishes a Commission on Combating Synthetic Opioid Trafficking to create a strategic approach to combating the flow of synthetic opioids into the United States.
The opioid crisis in New Mexico has had devastating effects on families across the state. Senator Heinrich has advocated for more resources to fight this epidemic - including measures like those in this years NDAA that penalize other countries for their involvement in the flow of illicit substances to the United States.
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Bill To Create White Sands National Park Heads To Trump For Signature - KRWG
Apple partnered with Color to bring genetic testing to its employees – Business Insider Nordic
The tech giant is granting a segment of its California-based employees access to DNA sequencing startup Color's genetic screenings free of charge through Apple's on-site health clinics, CNBCreports.
Business Insider Intelligence
Apple's dedicated health clinics dubbed AC Wellness wereunveiled at the beginning of 2018, and though they're located on-site, AC Wellness is a separate company from Apple. The Apple offshoot has supposedly been collaborating with Color for several months, sources divulged to CNBC.
Apple's move to offer its employees free access to genetic testing underscores its proactive approach to employee health services as it and other large, self-insured employers look for ways to stomp down medical spending.
Any insights extracted from Color's genetic tests will come with genetic counseling and be interpreted by AC Wellness docs which could guide customized, effective care.Color's test pinpoints gene mutations linked to common and costly conditions, like certain types of cancer and heart disease.
Theoretically, if a patient's genetic test comes back with a result that's cause for concern, doctors could formulate a personalized treatment plan that helps patients take preventative moves to sidestep disease development or progression and, in the case of cardiovascular disease, Apple could save big, considering heart disease costs could top$1 trillionin the US over the next two decades, per an RTI International study.
Further, providing employees with Color's service which comes with geneticcounselingand could help steer docs' care is a smart move since only asliverof doctors think physicians have the knowledge and skill set needed to help patients comprehend direct-to-consumer genetic test results, per a 2019 study.
And Apple's tie-up with Color comes as self-insured employers are looking for innovative ways to build up an armor against an impendingrisein medical costs.We're seeing prominent businesses take action to cut down on healthcare costs by offering services to connect employees with fast access to care: Amazon recentlylaunchedAmazon Care a virtual care service for its employees and Walmartexpandedtelehealth offerings and debuted a personalized health concierge program for its workers.
Employers' average annual premium contribution reached an all-time high of$14,500in 2019 up from the $9,800 they shelled out a decade earlier and as this number climbs, self-insured employers will need to continue to develop innovative solutions to help curb spending.
And while Apple's alliance with Color might hint at a future in which the tech giant incorporates genetic testing services into its clinical research play we're not sure this would go over well with consumers.
Genetic testing insights could be a value-add to Apple's aggressive clinical research endeavors.In recent months, Apple has made it clear that its health play hinges on forging clinical research partnerships: It's building out its Watch as a health tool, andflauntsalliances with medical research titans. And if it were to, for instance, purchase a genetic testing startup and aggregate that huge repository of data alongside its already-rich set of smartphone- and wearable-generated data Apple could become an even more valuable research partner.
But consumers are wary about sharing their health data let alone sensitive genetic information with big tech firms.Only about 10% of US consumers would be willing to hand off health info to a tech firm and of that minute percentage, only42%tap Apple as a trusted recipient, per Rock Health.
We think Apple would face a huge amount of scrutiny among consumers and docs alike if it tried to tie up more broadly with a genetic testing firm, especially in the wake of heightened wariness surrounding tech giants' use of health data: For example, Google is currently under investigation from the US Department of Justice after a partnership with health system Ascensionusheredin backlash from physicians who were unaware of the deal.
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Apple partnered with Color to bring genetic testing to its employees - Business Insider Nordic
One woman’s genetic test might have saved her father’s lilfe – WSAW
(WZAW) -- Jenna Finley is a board-certified genetic counselor at Invitae, a leading medical genetics company. After counseling patients for years, Jenna knew the power with genetic information, but with no strong family history of disease she wasnt concerned about her risk. She mostly wanted to better understand the experience of her patients.
Her results revealed a genetic change in a gene associated with an increased risk of breast cancer. She went to see her doctor, who referred her to a high-risk breast cancer clinic, where she worked with a team to establish a plan to carefully monitor her health. Now any signs of breast cancer that develop will be caught early.
With her job experience, Jenna knew that the other members of her family should be tested in case they, too, faced an increased health risks based on their shared genes. In fact, her mothers test came back positive for the same cancer-causing genetic change Jenna has. More surprisingly, her father learned that he has a disorder that causes excess iron in the bodys organs, which can be fatal.
Jennas father quickly went to his doctor who found his iron levels were so high that he had to begin treatment immediately to avoid potentially irreversible damage. Had Jenna and her parents not gone through the process of genetic testing, they might have ever known about these health conditions.
Studies show that increased genetic risks are common. In fact, 1 in 6 consumers in the U.S. have a medically actionable disorder and may not know it.
Genetic testing help with a wide range of health questions, whether youre current facing a health issue, planning for a family, currently expecting or interested in preventing disease.
For more information, visit http://www.invitae.com
Continued here:
One woman's genetic test might have saved her father's lilfe - WSAW
Gene tests for all women with breast cancer could save money and lives – Harvard Health
Published: January, 2020
Doing genetic tests on all women with breast cancer, as compared with the typical practice of just testing those with a family history of the disease, is worth the extra cost, according to a study published online Oct. 3, 2019, by JAMA Oncology. The study authors say their findings should prompt the expansion of genetic testing to all women diagnosed with breast cancer. It's clear that testing breast cancer patients for genetic variants that raise breast cancer risk (such as BRCA1, BRCA2, and PALB2) would enable doctors to identify more women who carry these variants and who might benefit from preventive strategies. But researchers wondered whether doing so would be too costly. To answer that question, they used a computer model to analyze data from more than 11,000 women. They found that not only would the cost of testing all American women with breast cancer be balanced out by later savings on health care services, but also that just one year of testing could prevent an estimated 9,700 new cases of breast and ovarian cancer and 2,400 deaths.
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Gene tests for all women with breast cancer could save money and lives - Harvard Health
‘We have hope’: Flames assistant GM Chris Snow diagnosed with ALS – National Post
Calgary Flames assistant general manager Chris Snow has been diagnosed with ALS, also known as Lou Gehrigs disease.
The club made that heart-wrenching announcement Wednesday by sharing a letter from his wife, Kelsie.
Snow, an analytics expert, has been on staff at the Saddledome since 2011. The 38-year-old father of two is now enrolled in a clinical trial to treat the disease.
A letter from Kelsie Snow
Dear Hockey Family,
Im here to share news we prayed so hard wed never have.
Chris has been diagnosed with ALS.
ALS is a horrible disease, and when we went to Miami to see one of the best ALS doctors and researchers out there, we prayed hard. We believe there are miracles in the world and maybe, maybe we would get one.
And we did, just not the one wed hoped for.
In the same breath as the doctor telling us that Chris was in the early stages of ALS, he also gave us hope. The next step, he said, was to enroll Chris in a clinical trial for the most encouraging ALS gene therapy treatment to come along. The drug targets a specific genetic mutation that has devastated Chris family. Just over one year ago Chris dad passed away from ALS. We have also lost both of Chris paternal uncles and his 28-year-old cousin to this disease.
In the simplest terms, this drug works by silencing the effects of the mutated gene, and in Miami we could see how hopeful the doctor felt. So hopeful that when I asked if he believes this drug could stop progression entirely, he said, We dont know, but its not outside the realm of possibility.
And so we are leaning into that possibility, as hard as we can, working to stay positive and living with intention every single day. And now we believe we have results to lean into as well.
Chris has been in the trial for several months, and while we do not know whether he is on the actual drug or a placebo, the disease since that initial dose does not seem to have progressed. His right hand and forearm remain the only affected areas of his otherwise strong and healthy body.
Someone has to be the first person to live with ALS rather than die from it, and one thing Ive always known about Chris is that he finds a way. No matter the obstacle, no matter how unprecedented the situation may be he always, always finds a way.
We know that our hockey family will want to help, and we appreciate that so much. Heres how you can do that.
Be positive and hopeful with us, pray for us in whatever way you pray, and dont treat us most especially Chris differently than you always have. He is the same person today he was yesterday and he will be the same person tomorrow and in two months and beyond. Hug your family, wring all the joy from each moment of your life, play with your children, and be present all things at which Chris has always been wonderful.
Continue to love us and love our kids. Of all the devastation this diagnosis brought, the idea of telling the two of them they were going to lose their dad was the most crushing. But now we have hope and, we believe, a different story.
The most tangible way you can help us is by donating to research. ALS is a rare disease, and rare diseases arent easily cured. Fewer than 20,000 people in North America are estimated to be living with ALS. Of them only 2,000 are living with familial ALS, the kind caused by a gene passed down within a family. And yet this has torn through Chris family. At the University of Miami researchers are focused on developing treatments for ALS, including those with familial forms of the disease. They have pioneered the study of the pre-symptomatic stage of ALS with the goal of one day being able to delay or even prevent the disease. With your help they can afford to do more and do it faster. To donate, please visit this link:http://uom.convio.net/goto/chrissnow
The next most powerful thing you can do for us is to believe in this treatment. Our hope is rooted in the results we believe we are seeing and in the optimism expressed by doctors who have spent their careers studying this disease.
As our neurologist said after Chris received his first dose in the trial Were here to make history.
Kelsie Snow
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'We have hope': Flames assistant GM Chris Snow diagnosed with ALS - National Post
Augmented Reality is the Future of Healthcare Industry – AiThority
Augmented Reality is already disrupting Healthcare, changing the way physicians see data and their patients. Its being used for patient and doctor education, surgical visualization, disease simulation, and may even help save lives enhancing patient treatments, and outcomes.
Its even making surgery safer, providing surgeons with 3D overlays to enhance the visibility of organs, veins, and diagnosis reports, cutting down on the chance for error. In addition, Augmented Reality plays a crucial role in education, providing real-life simulation surgeries for doctors without the risk of getting it wrong with a live patient. Neurosurgeons have even used Augmented Reality to remove a three-centimeter wide brain tumor in a patients parietal lobe. The best part all of this is being done by ARs ability to blend digital imagery with the real world.
By 2023, the global Augmented reality in Healthcare could become a $1.32 billion market. All of that is creating a sizable opportunity for companies including NexTech AR Solutions, Intuitive Surgical Inc., Medtronic PLC, Abiomed Inc., and Thermo Fisher Scientific Inc.
Read More: Measuring CCPA Preparedness of Big Data Companies: Facts and Insights
NexTech AR Solutions BREAKING NEWS: NexTech AR Solutions, the leader in Augmented Reality (AR) for e-commerce and AR learning applications is pleased to announce that Sterilis Solutions, one ofthe United Statesmost innovative medical waste device manufacturers, has signed on for both NexTechs WebAR offering as well as its AR University. Todays announcement marks the beginning of a significant new use case and opportunity for NexTechs AR technology in the medical device market, which according to Fortune Business Insights is worth$150 billion. Sterilis will be providing Nextechs AR learning assets to its leading dealers and their Sales teams.
Andy Marshall, CEO, Sterilis stresses the critical importance of using AR technology from NexTech AR Solution, AR is more powerful than a brochure especially with the interaction. He continued, We will use it to educate our customers on the core functions of our device as well as supporting our Sales team in showing off this 1,100 lb. machine to our global dealer network.
Echoing the business impact that NexTech AR can have on leading medical device manufacturers such as Sterilis,Evan Gappelberg, CEO of NexTech stated,
We are excited that Sterilis has adopted NexTechs powerful and industry-leading Augmented Reality offering to drive both its product marketing and client education activities. Because our proprietary 3D Augmented Reality (3D/AR) solution and our AR learning tools works on any AR-enabled mobile phone it will help Sterilis to vastly improve its product demonstration capabilities while significantly enhancing its ability to communicate key competitive features of its products at trade shows and really everywhere. He continues, Sterilis has chosen NexTech as a key business growth partner.
Evan added, Unlike other AR/VR companies which charge a fortune and which often require special software and training, NexTechs easy to use and monthly revenue-focused product suite allows its clients to do more and to sell more. All of this results in a stronger bottom line for our customers and recurring revenues for us.
Read More: Like A Machine: How RPA, ML And AI Deliver Smoother And More Streamlined Processes To Accounts Receivable Departments
Intuitive Surgical Inc.announcedU.S. Food and Drug Administrationclearanceof two innovative technologies for two of the companys da Vincisurgical systems to help improve procedures that require sealing. Intuitives E-100 generator is its first internally developed robotic generator to power two key instruments on the da Vinci X and Xi systems. Vessel Sealer Extend is the flagship instrument in the da Vinci energy sealing portfolio today, and the new SynchroSeal instrument offers enhanced capabilities in general surgery.
We are pleased to receive FDA clearance, providing surgeons an additional tool for the X and Xi da Vinci platforms, saidBob DeSantis, Intuitives Senior Vice President and General Manager for Instruments and Accessories. We developed SynchroSeal and the E-100 generator to help surgeons quickly seal and transect tissue and vessels, facilitating efficient technique.
Medtronic PLCandChristianaCareannounced a collaboration designed to improve outcomes for ChristianaCare patients inDelawareand the surrounding region. The five-year agreement will focus on developing and deploying value-based healthcare initiatives to help ChristianaCare apply the right medical technologies and therapies to patients who may benefit most, with shared financial accountability between ChristianaCare and Medtronic to improve patient outcomes while reducing the cost of care.
Theres a general consensus that a fee-for-service system is not sustainable, and a value-based system is the way to go, but how becomes a question. We want to take that on, but transformation can only happen through collaboration with others with aligned views and aligned reward mechanisms, said Omar Ishrak, Chairman and Chief Executive Officer of Medtronic.
ChristianaCares shared commitment to developing value-based healthcare initiatives makes them an ideal partner for Medtronic.
Abiomed Inc.announced initiation of theST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the hearts left ventricle for 30 minutes with an Impella heart pumpprior to opening blocked arteries will reduce infarct size after a heart attack and lead to a reduction in future heart failure rates.
The first patient in the multi-center trial was enrolled atSpectrum HealthinGrand Rapids,Michigan, by Kevin Wolschleger, MD. The Impella CP heart pump will be used in the STEMI DTU randomized controlled trial, which will study unloading prior to reperfusion as a therapy to reduce heart failure risk.
We are honored to be the first to enroll in this important study which builds on earlier research that shows promise for slowing the growing epidemic of heart failure and improving outcomes for heart attack patients around the world, said Dr. Wolschleger, an interventional Cardiologist at Spectrum Health. Spectrum Health has one of the longest Impella experiences in the United States, and we are proud and excited to be a part of this pivotal clinical trial that has the promise to bring this paradigm-changing therapy to patients, said David Wohns, MD, Chief of Cardiology at Spectrum Health.
Thermo Fisher Scientific Inc. officially opened its new$90 million viral vector CDMO (contract development and manufacturing organization) site in Lexington, Mass. The 50,000-square-foot facility will add more than 200 jobs and support the development, testing and manufacture of viral vectors, which are critical to advancing new life-saving gene and cell therapies globally. Thermo Fishersinvestment in both the regional economic development of the Commonwealth and its commitment to furthering STEM education for young women will well serveMassachusettsand its communities, said GovernorCharlie Baker. We look forward to working together to continue to build upon and strengthen the states role as a global leader in innovation.
Earlier this year, Thermo Fisher completed the acquisition of Brammer Bio, adding this leading viral vector CDMO to its Pharma Services business. The new Lexington site provides much-needed capacity for viral vector development and manufacturing, which to date has been a bottleneck for Biotech companies. This investment is part of a larger strategy to accelerate commercialization of new therapies by providing a range of services from drug development through clinical trials to commercial manufacturing to support Pharma and Biotech companies of all sizes.
The demand for new gene therapies has outpaced capacity, and were in a unique position to partner with our customers to help them accelerate development and production of medicines that will ultimately benefit patients suffering from rare diseases, said Michel Lagarde, executive Vice President of Thermo Fisher Scientific. Were also excited to create 200 new jobs that support the thriving Biotech industry in Massachusetts.
Read More: Worlds Largest Blockchain Application Competition Klaytn Horizon Winners Announced
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Augmented Reality is the Future of Healthcare Industry - AiThority
The Best Augmented Reality Stocks for 2020 – PR Newswire UK
Financialnewsmedia.com News Commentary
PALM BEACH, Florida, Dec. 17, 2019 /PRNewswire/ -- Augmented reality is already disrupting healthcare, changing the way physicians see data and their patients. It's being used for patient and doctor education, surgical visualization, disease simulation, and may even help save lives enhancing patient treatments, and outcomes, according to Med City News. It's even making surgery safer, providing surgeons with 3D overlays to enhance visibility of organs, veins, and diagnosis reports, cutting down on the chance for error. In addition, augmented reality plays a crucial role in education, providing real-life simulation surgeries for up and coming doctors without the risk of getting it wrong with a live patient. Neurosurgeons have even used augmented reality to remove a three-centimeter wide brain tumor in a patient's parietal lobe. The best part all of this is being done by AR's ability to blend digital imagery with the real world. By 2023, says Market Research Future, the global augmented reality in healthcare could become a $1.32 billion market. All of that is creating sizable opportunity for companies including NexTech AR Solutions(OTCQB: NEXCF)(CSE: NTAR), Intuitive Surgical Inc. (NASDAQ:ISRG), Medtronic PLC (NYSE:MDT), Abiomed Inc. (NASDAQ:ABMD), and Thermo Fisher Scientific Inc. (NYSE:TMO).
NexTech AR Solutions(OTCQB: NEXCF)(CSE: NTAR) BREAKING NEWS: NexTech AR Solutions, the leader in augmented reality (AR) for eCommerce and AR learning applications is pleased to announce that Sterilis Solutions, one of the United States' most innovative medical waste device manufacturers, has signed on for both NexTech's WebAR offering as well as its AR University. Today's announcement marks the beginning of a significant new use case and opportunity for NexTech's AR technology in the medical device market, which according to Fortune Business Insights is worth $150 billion. Sterilis will be providing Nextech's AR learning assets to its leading dealers and their sales teams. Andy Marshall, CEO, Sterilis stresses the critical importance of using AR technology from NexTech AR Solution, "AR is more powerful than a brochure especially with the interaction." He continues that, "We will use it to educate our customers on the core functions of our device as well as supporting our sales team in showing off this 1,100 lb. machine to our global dealer network."
Echoing the business impact that NexTech AR can have on leading medical device manufacturers such as Sterilis, Evan Gappelberg, CEO of NexTech states: "We are excited that Sterilis has adopted NexTech's powerful and industry-leading augmented reality offering to drive both its product marketing and client education activities. Because our proprietary 3D augmented reality (3D/AR) solution and our AR learning tools works on any AR enabled mobile phone it will help Sterilis to vastly improve its product demonstration capabilities while significantly enhancing its ability to communicate key competitive features of its products at trade shows and really everywhere." He continues, "Sterilis has chosen NexTech as a key business growth partner. Unlike other AR/VR companies which charge a fortune and which often require special software and training, NexTech's easy to use and monthly revenue-focused product suite allows its clients to do more and to sell more. All of this results in a stronger bottom line for our customers and recurring revenues for us."
Other related developments from around the markets include:
Intuitive Surgical Inc. (NASDAQ:ISRG) announcedU.S. Food and Drug Administrationclearanceof two innovative technologies for two of the company's da Vincisurgical systems to help improve procedures that require sealing. Intuitive's E-100 generator is its first internally developed robotic generator to power two key instruments on the da VinciXand Xisystems. Vessel Sealer Extend is the flagship instrument in the da Vinci energy sealing portfolio today, and the new SynchroSeal instrument offers enhanced capabilitiesin general surgery. "We are pleased to receiveFDAclearance, providing surgeons an additional tool for the X andXi da Vinciplatforms," saidBob DeSantis, Intuitive's Senior Vice President and General Manager for Instruments and Accessories. "We developed SynchroSeal and the E-100 generator to help surgeons quickly seal and transect tissue and vessels, facilitating efficient technique."
Medtronic PLC (NYSE:MDT) and ChristianaCare announced a collaboration designed to improve outcomes for ChristianaCare patients in Delaware and the surrounding region. The five-year agreement will focus on developing and deploying value-based healthcare initiatives to help ChristianaCare apply the right medical technologies and therapies to patients who may benefit most, with shared financial accountability between ChristianaCare and Medtronic to improve patient outcomes while reducing the cost of care. "There's general consensus that a fee-for-service system is not sustainable, and a value-based system is the way to go, but 'how' becomes a question. We want to take that on, but transformation can only happen through collaboration with others with aligned views and aligned reward mechanisms," said Omar Ishrak, chairman and chief executive officer of Medtronic. "ChristianaCare's shared commitment to developing value-based healthcare initiatives makes them an ideal partner for Medtronic."
Abiomed Inc. (NASDAQ:ABMD) announced initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart's left ventricle for 30 minutes with an Impella heart pumpprior to opening blocked arteries will reduce infarct size after a heart attack and lead to a reduction in future heart failure rates. The first patient in the multi-center trial was enrolled atSpectrum HealthinGrand Rapids, Michigan, byKevin Wolschleger, MD. The Impella CP heart pump will be used in the STEMI DTU randomized controlled trial, which will study unloading prior to reperfusion as a therapy to reduce heart failure risk. "We are honored to be the first to enroll in this important study which builds on earlier research that shows promise for slowing the growing epidemic of heart failure and improving outcomes for heart attack patients around the world." said Dr. Wolschleger, an interventional cardiologist atSpectrum Health. "Spectrum Health has one of the longest Impella experiences inthe United States, and we are proud and excited to be a part of this pivotal clinical trial that has the promise to bring this paradigm changing therapy to patients," saidDavid Wohns, MD, chief of cardiology atSpectrum Health.
Thermo Fisher Scientific Inc. (NYSE:TMO) officially opened its new$90 millionviral vector CDMO(contract development and manufacturing organization) site inLexington, Mass.The 50,000-square-foot facility will add more than 200 jobs and support the development, testing and manufacture of viral vectors, which are critical to advancing new life-saving gene and cell therapies globally."Thermo Fisher'sinvestment in both the regional economic development of the Commonwealth and its commitment to furthering STEM education for young women will well serveMassachusettsand its communities," said GovernorCharlie Baker. "We look forward to working together to continue to build upon and strengthen the state's role as a global leader in innovation."Earlier this year,Thermo Fishercompleted the acquisition ofBrammer Bio, adding this leading viral vector CDMO to its Pharma Services business.The newLexingtonsite provides much-needed capacity for viral vector development and manufacturing, which to date has been a bottleneck for biotech companies. This investment is part of a larger strategy to accelerate commercialization of new therapies by providing a range of services from drug development through clinical trials to commercial manufacturing to support pharma and biotechcompanies of all sizes. "The demand for new gene therapies has outpaced capacity, and we're in a unique position to partner with our customers to help them accelerate development and production of medicines that will ultimately benefit patients suffering from rare diseases," saidMichel Lagarde, executive vice president of Thermo Fisher Scientific. "We're also excited to create 200 new jobs that support the thriving biotech industry inMassachusetts."
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The Best Augmented Reality Stocks for 2020 - PR Newswire UK
The Politics Of HIV – The Political Football Has Been Fumbled – Seeking Alpha
Introduction
In Trump's 2019 State of the Union Address, the topic of eradicating HIV morphed into a campaign promise with HIV poster child Gilead (GILD) getting most of the accolades due to their advances in prevention drugs. Almost 9 months later (last month), the Trump administration reversed course and sued Gilead which means the position of "HIV poster child" is up for grabs again. Since Trump seems to have knocked the ball out of Gilead's hands, it's unclear if they will be able to repair the damage and reclaim their position or if a new company will rise to the occasion and become the newly anointed.
Trump's 2019 SOTU Address
During Trump's 2019 State of the Union Address, he has announced a strategy to stop the spread of HIV by 2030 by concentrating resources on hot spots where half the new infections occur. After the State of the Union details from the Secretary of Health and Human Services (HHS) Alexa M Azar II, who coordinated the plan, said that their goal was to focus on the 48 countries where half the infections occur and to reduce new infections by 75% along with ending the HIV epidemic in America. After the State of the Union, advocates like Dr. Anthony Facui, director of the National Institute of Allergy and Infectious Diseases, suggested an increase in antiretrovirals and prevention medicine at the Conference on Retroviruses and Opportunistic Infections (CROI). This increased emphasis on treatment was positive for HIV drugmakers like Johnson and Johnson (JNJ), Mylan (MYL), and Pfizer (PFE). Treatment and prevention stocks Gilead (GILD), GlaxoSmithKline (GSK), and Merck (MRK) received the biggest boost from the news, but this year, a new player with disruptive technology might be in the works. Which HIV company could be the biggest beneficiary from this Trump Administration and HHS initiative?
Trump's HIV Initiative
The architect of Trump's plan, Alex Azar, wrote an article after the State of the Union detailing how the Trump Administration and the Department of Health and Human Services are going to reach their goals using existing medicine in conjunction with pre-exposure prophylaxis (PrEP) medication. They are targeting resources to "geographic hotspots", which consists of 48 counties and some other areas and which constitute over 50% of new diagnoses in the United States. Their strategy can be summed up into "Diagnose, Treat, Protect, and Respond." Early detection is critical and getting people on the treatment regimen prevents transmission by keeping the viral loads in check. Additionally, people at risk of contracting HIV have new PrEP drugs like DESCOVY and TRUVADA made by GILD. Their response plan is to use CDC data to rapidly detect and treat growing HIV clusters to prevent new infections. If this model is successful they plan to roll it out on an international scale. The goal of the initiative is to "reduce new infections by 75 percent in the next five years and by 90 percent in the next ten years, averting more than 250,000 HIV infections in that span."
Trump's HIV Plan
The Past Year In Review
There have been many advancements in HIV treatment since this year's State of the Union address. A second patient, in addition to the famous decade-old case of Timothy Ray Brown, was cured of HIV. One drug manufacturer came out with a once a month injectable shot. CRISPR gene-editing technology was used to edit a stem cell implant aimed at curing HIV. Last but not least, a salvage therapy had over a 90% responder's rate with virtually no side effects. If history repeats itself, Trump will double down on his plan to defeat HIV, and unveil more details at the next State of the Union address in February 2020. The State of the Union address is well known for its impact on highlighting winners and losers among the presidential administration's initiatives. HIV is an anticipated winner again this year, but Gilead may not participate because tension has been on the rise between Gilead and the Trump administration. If HIV is mentioned at the State of the Union, it's expected the additional nuances of Trump's HIV plan will come to light the following month at the Conference on Retroviruses and Opportunistic Infections (CROI). This article speculates on some of the big HIV industry players.
The Trump administration, through the Department of Justice (DOJ), filed a patent infringement lawsuit on November 6, 2019 against Gilead seeking damages for patent protection. The Department of Health and Human Services had patents related to pre-exposure prophylaxis (PrEP) for HIV prevention. HHS asserted that GILD "willfully and deliberately induced infringement on the HHS patents." Due to the infringement, GILD allegedly profited from research funded by hundreds of millions of taxpayer dollars and reaped billions in revenues from PrEP through the sale of Truvada and Descovy.
Trump is very volatile, and compared to prior presidents, downright aggressive, so there is a chance that he goes on the attack during his State of the Union address against PrEP drug manufacturers that have taken advantage of the American people. Since PrEP was one of two pillars of Trump's plan, it's safe to say that his administration is now looking for another poster child. On the surface, Merck or GlaxoSmithKline would be the logical alternatives, but something possibly bigger is brewing in the HIV space, which is covered later in this article.
The amfAR Institute for HIV Cure Research is focused on a scientific basis for a cure by the end of 2020. They defined a functional cure as something that would end an individual's lifelong need for drug treatment to keep the virus in check. They identified four key challenges needed to develop a cure: pinpoint the precise locations of the latent reservoirs, determine how they are formed, persist and quantify the amount of virus in the reservoirs, and finally, eradicate them from the body. Gilead is a key partner in this collaboration.
There are many types of T-Cells, but only the CD4+ T-Cell can host the virus. The issue with the existing antiretroviral therapy (ART) is that they work in the blood to reduce the circulating virus, not the virus in the tissues. Only 3-5% of a person's CD4+ cells are circulating at any given time; the remainder are typically compartmentalized in a reservoir in organs such as the brain, lymph nodes, gut, and male/female reproductive tract. According to the MDPI Journal Gilead's planned mechanism of eradication is to use GS-9620, a TLR7 agonist, to force latent HIV from the virus's immune cell reservoir. Once released, broadly neutralizing antibody PGT121 would attach to it and clear it from the blood. This methodology is known as a shock and kill tactic and was presented at the 2018 CROI meeting. Tests in monkeys revealed that this approach delayed viral rebound following ART from 21 days in the control to a median rebound time of 112 days. In July, the company had a phase 1 readout that showed the drug was well tolerated with no Grade 3 or Grade 4 drug-related adverse events. Their finding was that "the results support studies in the potential role of Vesatolimod as part of combination regimens aimed at achieving ART-free control of HIV." The ART-free control verbiage, unfortunately, appears to be well short of a cure. This advance coupled with the patent infringement issue doesn't appear to have enough zest to make it on Trump's radar.
Merck (MRK) had a similar plan called "kick and kill" in which is used a cancer drug called Vorinostat as an activating agent to clear the body of its viral reservoir and get the immune system to respond using it innate immunity. In Merck's RIVER study, released in July 2018, 60 men who recently acquired HIV started ART and got their viral loads to undetectable levels and then received the "kick and kill." This consisted of Vorinostat and an anti-HIV vaccine. Results were very disappointing and showed that there was no impact on copies/mL compared to ART alone. It's important to note that the mice study was marginal in comparison to GILD's monkey study with GS-9620.
Merck is also developing a one-year subcutaneous implant. Anthony Fauci, the head of the National Institute of Allergy and Infection Diseases characterized "an implant for 1 year has enormous potential [...] that could be a game-changing advance." The drug is called MK-8591 or islatravir, and inhibits an enzyme that is needed for replication of HIV. Merck conducted a study in 12 uninfected people and measure the blood levels of islatravir 4 weeks after removal. In half of the cohort that received the higher dose, levels were so high that researchers were able to project that the release of the drug would be 12 - 16 months. No safety issues surfaced in the pilot study. The drug is entering phase 2 studies and has only dosed 12 people so the findings
Viiv Healthcare, the Pfizer and GSK owned HIV joint venture, also is testing cabotegravir in a phase 3 study as an intramuscular injection for the prevention of HIV infection. The phase 2 study results showed overall positive safety and tolerability data, where most patients favored the 12-week injection over pills over daily pills. Due to lower than expected exposure found in some patients in the phase 2 data, the phase 3 study will proceed with a lower dose and 6-week injections.
Almost two years ago, the Gilead PrEP news was extraordinary, but the news now pales in comparison to a group of 5 human patients that have not taken ART's for close to 5 years and have yet to experience a viral rebound that will be discussed later in the article.
Bioethics Observatory Institute of Life Sciences
Timothy Ray Brown, known as the "Berlin patient," was the first person ever cured of HIV, which happened over a decade ago. The second patient cured of HIV is known as the "London patient." Both patients had myeloid leukemia and had total body irradiation to wipe out their T-cells before receiving their stem cell transplant. In both cases, the donor had a genetic mutation - which therefore is present in the donated stem cells - known as a CCR5 delta 32 mutation. People that have the CCR5 delta 32 allele do not have CCR5 receptors on their T-Cells and as a result are immune to HIV. The "Berlin patient" inspired Dr. Monique Nijhuis, from the University Medical Center of Utrecht in the Netherlands to develop a protocol to transplant HIV resistant genes with the intention of eradicating HIV from the patient. The European consortium is analyzing the results of 39 patients who have received transplants from CCR5 delta 32 donors. Dr. Carl Dieffenbach, the director of AIDS research for the National Institute of Health also endorsed this approach at this year's CROI conference and indicated that another was to genetically engineer a patient's immune cells through gene therapy to knock out the CCR5 receptor which is part of HIV's pathway into the T-Cell.
Timothy Ray Brown, right, and Dr. Gero Htter, the Berlin cancer doctor who gave Brown a lifesaving transplant that also cured him of HIV. Photo by Robert Hood / Fred Hutch News Service
There have been 3 HIV vaccine trials for efficacy worldwide. In 2004, the VaxGen candidates failed to offer any protection and halted its phase 3 trial in 2004. Later in 2007, the Phambili study was stopped for safety concerns. An ongoing trial of HVTN100 and HVTN702 is part of a consortium that includes the US Military, the Bill and Melinda Gates Foundation, NIAID, HVTN, GlaxoSmithKline (GSK), and Sanofi Aventis (SNY). Even though vaccines have had a bumpy road, Dieffenbach believes that we could give "remission in absence of eradication." This means that a patient's immune system would be trained to block HIV whenever sleeping HIV infected cells awake, which would be accomplished via injection of HIV blocking antibodies. On a different note, Janssen, a division of JNJ, is enrolling up to 3800 participants in eight countries who will get four vaccine injections over the course of a year. This study, termed the Mosaico study, will vaccinate patients with three different HIV strains, hoping to offer benefit in 65% of the study population. Prophylactic treatment is an ultimate goal in fighting HIV, but it has been elusive because the virus evolves so rapidly that it's difficult to target.
Path Toward a Functional HIV Cure
To understand what a "functional cure" means, it is helpful to recap what exactly HIV is and how existing drugs are currently treating the disease. HIV is a virus that selectively targets a patient's white blood cells known as T-Cells. These T-Cells help fight infections in our body and kill viruses, but the HIV virus exploits a weakness on the surface of the T-Cell. When an HIV virus comes in contact with the CD4 receptor and the CCR5 co-receptor, the virus gains entry into the T-Cell where it can replicate. The current standard of care is called Highly Active Antiretroviral Therapy (HAART) and what it does is target the virus's ability to replicate once already inside the cell, to keep the "viral load" down. It is well understood that keeping the viral load under 50 copies/mL both effectively prevents transmission of the disease and keeps the disease at bay for the existing infectee.
Frontiers in Immunology
Entry/Fusion Inhibitors - Superior Mechanism of Action, But Toxic
The approach to HIV treatment since the advent of HAART has been to mess up the virus' plan to replicate once inside the cell, but in theory, there is a better way. Instead of letting the virus inside the cell, fusion inhibitors block the CCR5 co-receptor and keep the virus outside the cell. With entry/fusion inhibitor treatment the virus can still bind to the CD4 receptor, but it is unable to get close enough to the cell membrane since the CCR5 co-receptor is blocked. Thus, it can't enter the cell and therefore it is unable to replicate. Even more importantly, replication of a virus is what allows for mutation, which ultimately leads to drug resistance as is common with HAART treatment regimens. Historically, fusion inhibitors like Pfizer's maraviroc and Merck's vicriviroc have shown efficacy in keeping viral loads down. However, side effects related to their method of CCR5 inhibition have limited their usage. The effects are apparent as Merck terminated the development of vicriviroc in 2010 and maraviroc has a black box warning for hepatotoxicity.
Corporate Presentation
Next Generation Entry/Fusion Inhibitor - Non Toxic
CytoDyn Inc. (OTCQB:CYDY) has developed a monoclonal antibody CCR5 antagonist called leronlimab to treat HIV with virtually no side effects compared to the nausea, fatigue, and trouble sleeping that come with the HAART regimen. The drug has an impressive safety and efficacy profile. After 24 weeks of leronlimab therapy, 81% of patients had suppressed viral load compared to 43% from the last drug approved in the study's patient population. There were no drug-related Serious Adverse Events (SAEs), giving it one of the best safety profiles in the HIV landscape. Leronlimab also addresses patient compliance as a once-a-week injectable with a 72 hour grace period. The drug also has a fast-track designation and a rolling BLA and is in a position to ask for accelerated approval. It hit its primary endpoint in a pivotal phase 3 trial. They have a very favorable label request with one drug resistance in 3 classes or one drug resistance in 2 classes with limited treatment options. Approval could represent a$1.7 to $3.4 billion market within the first year of approval based on Biovid's Market Research. After expected approval, they plan to do a label expansion to switch to monotherapy maintenance.
Corporate Presentation
It's important to note that 565 leronlimab monotherapy patients have literally thrown away HAART, the standard of care, for close to a year. Five special patients have even been off the side effect heavy HAART 5 years, demonstrating leronlimab's considerable resilience to patients' developing drug resistance, attributable to the fact that leronlimab mostly prevents the virus from ever replicating. Leronlimab may prove to be a superior option over HAART for many patients.
The HAART standard of care, which leronlimab theoretically has the potential to disrupt, represents a >$15 billion franchise for GILD, but the leronlimab monotherapy patients are living ART-free and have complete control of their HIV. Contrast leronlimab's viral rebound data to GILD's GS-9620 animal study, which saw viral loads rebound in 112 days (less than 4 months). Patients in CytoDyn's monotherapy trial are essentially represented by the orange line in the Functional Cure graphic (a few graphics) above, and many patients could remain functionally cured without side effects for years to come, since CytoDyn doesn't have any strong evidence of viral rebounds yet.
Prevention in HIV is all about keeping the viral load under 50 copies/mL, which the FDA considers an undetectable level and incapable of spreading the disease. As a once a week injectable, PRO 140 (leronlimab) offers convenience to the patient, virtually no side effects, and essentially keeps the virus away from the T-Cells and unable to replicate. Here's a nice analogy: HIV is like having little piranha in your blood that only eats T-Cells. The HAART treatment lets the piranha eat the T-Cell but slaughters most but not all of its offspring. Leronlimab, on the other hand, puts a Teflon coating around the T-Cells so the piranha have nothing to eat, so they die from malnutrition.
In a prevention setting, if a person at risk is given leronlimab and exposed to the virus the theory is that the virus will be blocked from replicating and eventually defenses in the body will break it down. This theory might even be applied to patients diagnosed with HIV. If this is done long enough perhaps the virus will eventually break down. Esteban Hernandez-Vargas said that " latently infected resting memory CD4+ T cells are the only cell type in which it has been clearly demonstrated that replication-competent virus can persist for several years in patients." Some patients have been on leronlimab for close to 5 years and at some point, this group of patients would be ideal for that sort analysis to see if they have in fact been cured.
The Thai Red Cross AIDS research center is initiating a PrEP clinical trial in subjects at high risk of HIV infection. Leading scientific advisor Dr. Jonah Sacha is conducting the research and CytoDyn has a Memorandum of Understanding with the Tai Red Cross to develop the HIV PrEP clinical trials. Sacha will also oversee the PrEP cure developments. Supporting PrEP and cure initiatives is the independent leronlimab data from the PRESTIGO Registry Study Group, which is to be presented at CROI. The people in this study are heavily treatment-experienced (HTE) patients that averaged at least 4-classes of drug resistance. The group of patients in this PrEP study are actually less sick than in the leronlimab phase 3 groups, where leronlimab managed to yield a whopping 90% responders rate. The PrEP responders rate to be announced at CROI might be very high. If the majority of HIV positive patients have no side effects, cannot transmit the disease, and has a fully functional immune system, this could be considered a functional cure, allowing Trump to claim a big win.
Throughout the article, little seeds have been planted to accentuate the case for a new player in HIV, who has a disruptive technology, backed by data on long term patients, who possibly could be cured with a drug that has little to no side effects. The CytoDyn story, once again, could be "too good to be true." However, the company is weeks away from a planned BLA submission that will result in a planned drug approval by June 2020, based on its rolling BLA and fast track status. In September, CytoDyn signed a non-binding licensing deal for $90 million from a major distributor. Once the drug is approved, the company has Samsung Biologics ready to provide them with up to $1.0 billion of inventory, based on anticipated drug prices, to meet the expected demand. CytoDyn also signed with distribution partners ready to market the drug. The pieces are in place for CytoDyn to start bringing in billions in revenue next year, except for one key thing. The company needs about $20 to $25 million to fund its operating costs while they are waiting for BLA approval over the next 6 months. This need for either a licensing deal or some type of financing seems to be dampening the enthusiasm for the technology as market participants await closure on financing terms or a licensing deal. It's been eerily quiet in the past two months because no big pharma company has made an even an overture toward what could be the most disruptive technology in the HIV space.
A Gilead investor might consider hedging his bets with the biggest threat in the HIV space. In a worst-case scenario for this investor, nothing happens and CytoDyn doesn't become a political football, then the investor can unwind the hedge after the CROI meeting. If something does happen then the hedge could be wildly profitable and even cover multiple situations included the licensing of the technology by a competitor. In all likelihood, the Trump lawsuit against Gilead could be much ado about nothing, as are most political events. However, can investors ignore 565 patients that were able to throw away their daily HAART regimen and defy big pharma? A 95% responder rate with prolonged remission and favorable safety is good enough to ignite a patient advocacy revolution, and as an investor, you don't want to be caught on the wrong side of the trade.
There are a lot of theories floating out there about how to cure HIV and how to deal with the HIV epidemic. The big picture is that Trump seems stalwart in his approach about eradicating HIV, but therein lies the opportunity. The challenge to investors in the coming months leading up to the State of the Union is figuring out which horse is he going to back. Gilead is the largest HIV drug maker in the world and was the golden child in HIV until the Trump lawsuit hit. This lawsuit should serve notice to GILD investors that they have been targeted by Trump. There is a body of evidence to suggest that CytoDyn has the goods to be crowned the new innovator in HIV. It's definitely a long shot that Trump would elevate a $120 million market cap company as the frontrunner, but it is possible.
The most likely scenario would be Merck and ViiV jockeying for position in their efforts to get top billing and dethrone Gilead. Both of them could potentially negotiate with the administration, but its not clear which company might have the best strategy for PrEP. Whoever is perceived to have the inferior PrEP solution may be forced to seek a license from another PrEP drug maker; however, they would need a drug asset close to approval. Fortunately for CytoDyn, leronlimab approval is only about 6 months away, and if the technology is as robust as presented in this article, a licensee (Merck or ViiV) and CytoDyn could cobble together a viable PrEP program in months and then file for a label expansion.
If Gilead gets wind of this strategy, they might try to play "spoiler", which would be a great outcome for CytoDyn. Regardless, the bottom line is that Trump hit Gilead hard, and they could be on the ropes in the PrEP race. The question for investors is: does Gilead wake up in time to fight back, or does Merck, ViiV, or possibly a CytoDyn collaboration with one of them knock Gilead out?
Disclosure: I am/we are long CYDY. 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.
Editor's Note: This article covers one or more microcap stocks. Please be aware of the risks associated with these stocks.
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The Politics Of HIV - The Political Football Has Been Fumbled - Seeking Alpha
Benefits of hormone replacement therapy – Augusta Free Press
Published Wednesday, Dec. 18, 2019, 12:25 pm
Front Page Business Benefits of hormone replacement therapy
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When women start getting closer to menopause, their ovaries produce less estrogen and progesterone. These are the two hormones that control the monthly cycle. They can also affect the health of the bones, heart, and even vagina. As such, hormone replacement therapy provides an excellent solution to women. It is a medication that contains female hormones to replace those that the body fails to make after menopause. This form of therapy can also be used in the treatment of some common symptoms of menopause, such as hot flashes and vaginal discomfort. However, in as much as hormone replacement therapy is beneficial for most women, it comes along with some risks. Everything has to be done right, and a reputable hormone clinic is a must. Be sure to click for more information on hormone replacement therapy.
For purposes of obtaining the perfect results, hormone therapy must be tailored to each person and re-evaluated from time to time to ensure its benefits are more than the risks. Some of the benefits of HRT include
When taking hormone replacement therapy, systemic estrogen that is present in pills, skin patches, creams, sprays, and gels remains quite useful. It is responsible for relieving troublesome menopausal hot flashes and night sweats. After menopause, most women dont produce enough levels of estrogen, and if thats not kept in check, it can be quite troublesome. Hot flashes and night sweats can be quite uncomfortable, and thats why hormone therapy works for most women.
Menopause comes along with many symptoms, including dryness and itching. Taking the recommended levels of estrogen helps in relieving these vaginal symptoms. It can be uncomfortable for women as they get older to encounter dryness and itching, and thats why most doctors recommend HRT. It has some risks, but when done right, it can be quite helpful.
During menopause, the womans body goes through a lot of changes, especially in making some essential hormones. That can irritate and in most cases, deprive one of their good nights sleep. Taking hormone replacement therapy helps keep the levels of estrogen and progesterone balanced. As a result, it enables one to sleep better at night. Its also worth noting that reduced night sweats play a significant role in having peaceful nights.
When women get older and start approaching menopause, many symptoms begin to manifest themselves. Dryness and itching are quite common, and can sometimes lead to burning and discomfort when having sexual intercourse. It can be quite frustrating for couples, and thats why most doctors advise women to seek help from reputable hormone clinics. This is because, in as much as hormone therapy is helpful, it has to be done right. Every woman is different from the other, and treatment has to be tailored for them only. Complacency can cause some adverse risks that can be life-changing.
Combining estrogen and progesterone therapy well can reduce the risk of colon cancer. Most women under menopause experience fluctuations in their estrogen and progesterone levels. When its not kept in check, it can cause colon cancer. However, with treatment, the risk of colon cancer can be reduced significantly.
The bone-thinning disease, also called osteoporosis is common when estrogen levels in the body start declining. Taking therapy from a hormone clinic helps women get access to systemic estrogen that protects one from their bones getting thinner. However, in as much as these process works, most doctors recommend other medications called bisphosphonates. These drugs are active and have minimal risks as compared to taking therapy.
According to research, estrogen can be used to reduce the risk of getting heart diseases. However, for that to work, treatment has to taken early in the postmenopausal years.
HRT is quite helpful for women approaching menopause. However, before deciding to take the treatment, women should carefully discuss the benefits and risks involved. There is a lot to take into account, including age, medical history, personal preferences, and risk factors, among others. The doctor has to make sure the treatment is the right option.
The majority of women that resolve to hormone replacement therapy for the short-term treatment of symptoms of the menopause, the benefits tend to outweigh the risks. However, women taking the medication should get re-assessed annually by their doctor. Always ensure you get help from a reputable hormone clinic to avoid getting exposed to other unwanted risks.
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Benefits of hormone replacement therapy - Augusta Free Press
3 Benefits of Giving Up Alcohol – Men’s Health
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The sober curious movement, or taking a break from alcohol, has become one of the year's biggest trends. And while you know that beer isn't exactly green juice, you may not be sure of why you should even give up alcohol.
In a new video, Facts Verse explains possible benefits of giving up alcohol for a single month. One major factor that you may not even consider are the costs associated with drinking. Facts Verse estimates that you could save up to $400, depending on the type of alcohol you prefer and frequency of bar visits. What's more, skipping the club could help you discover new hobbies and passions, according to the video.
In addition to saving you money, taking a break from booze can also save your skin. That's because alcohol is a diuretic meaning it lowers the amount of fluids in your body. The substance also decreases a specific hormone that helps you to retain water, according to the Cleveland Clinic. Taken together, this leaves your entire body dehydrated, which in turn, can make your skin lookand feeldry.
And some people who give up booze experience a very noticeable benefit: weight loss. Alcohol contains calories but offers little nutritional value, meaning it's entirely possible to drink upwards of 2,000 calories a day just in cocktails or beer, according to the video. Plus, happy hour is often accompanied by bar food, which increases the likelihood of consuming more calories than your body requires to maintain its weight.
Watch the entire video to learn about more reasons you may want to join the sober curious movement.
The 2010s were the decade of trans – The Spectator USA
Transgender ideology wasnt invented in the 2010s, but this was the decade when it gripped our culture in its venomous maw and refused to let go. Heres how trans grew from fringe oddity to a massive force affecting schools, parenting, prisons, policy, academia, sports, law enforcement, language and the arts.
In 2009, Susie Green, who will become Chair of UK gender clinic Mermaids, takes her son to Thailand for vaginoplasty. Jackie Green becomes the youngest person in the world to undergo a sex change operation, at age 16. Meanwhile, trans woman and trans humanist Martine Rothblatt foresees the end of our species as we know it, andclaimsthat transhumanism builds on transgenderism, broadening the driving mindset from a gender ideal to a human development ideal.
Trans began the decadeas an outlier. It became something tolerated out of compassion. It has become a medical-legal monster, with activists claiming to redefine woman as a feeling, with self-identification trumping the basic facts of biological sex.And if you disagree, youre transphobic. Welcome to the 2020s!
At 10 years old,Jazz Jenningsis already out as trans.
Children become the subject ofmedical experimentation. Britains National Health Service approves medical experiments which will chemically castrate gay children in attempt to correct gender-nonconformity.
We now being told that affirmation of trans individuals is all about compassion. We need to knowwhat trans gender meansand how important surgery is.New York magazinesays that it takes a powerful act of imagination to understand what a transgender child, in his perfect little body on the changing table, might be feeling, or why he might become terrified as adolescence approaches.
The American Psychiatric Associationupdates its manual, to replace gender identity disorder with gender dysphoria.
Now 13 years old and wearing dental braces as well as female dress, Jazz Jennings isparadedon ABC News.
In Britain, the gender clinic at theTavistock Clinic gives 12 year-olds hormone blockers to prepare for transition. The treatment halts the onset of puberty preventing children from developing the sexual characteristics of the gender they were born.
Trans woman Parker Molloy writes amissive:I am a woman, but on such a frequent basis, Im told this is not true. Im told that Im genetically or biologically male. Im told that Im not a real woman. I have to ask: What constitutes a real woman? How am I not one? Is it because of my chromosomes? I dont think thats fair
The splendidly surnamed trans actress Laverne Cox, the first trans person to grace the cover ofTIMEmagazine, explains that most of us are insecure about our gender.
IntheNew Yorker, Michelle Goldberg sits on the fence: Trans women say that they are women because they feel femalethey have womens brains in mens bodies. Radical feministsbelieve that if women think and act differently from men its because society forces them to.
Facebook offers56 gender optionsfor users to choose from.
Susie Greens trans daughter Jackie is now 21, and Green speaks out against those who call her parentingabusive. She claims that even before she could speak my daughter had made her preferences clear.
Bruce Jenner becomes Caitlyn, and graces the cover ofVanity Fair. Trans MMA fighterFallon Foxdefeated her opponent, Tamikka Brents, by TKO at 2:17 of the first round of their match. Brents eye injury resulted in a damaged orbital bone that required seven staples. Now thats equality.
Michelle Goldberg is back. InSlate, she reminds us that, Most progressives now take it for granted that gender is a matter of identity, not biology, and that refusing to recognize a persons gender identity is an outrageous offense.
In the UK, theParliamentary Women and Equalities Committee Reportremoves sex-based protections.My Transgender Kidappears on the BBC. Itsreported that the Tavistock and Portman gender clinic has seen referrals increase by 50 percent every year since 2009.
Rachel Dolezal claims to betransracial.Trans abledturns out to be a thing.
Teen girls protest trans girls use of girlslocker room.
The year of the bathroom. A North Carolina law ispasseddisallowing trans people from using the bathroom of their choice. The State issuedby Obamas Department of Justice, whichtellsevery public school district in the country to allow transgender students to use the bathrooms that match their gender identity.
The director of the ACLU in Georgialeaves her postrather than fight for trans bathroom rights.
Male bodied trans studentscompeteagainst girls in high school sports. Female bodied transpregnant personsare lauded as the first male mothers.
The National Institute of Healthlaunchesthe largest-ever study of transgender youth, but also only the second to track the psychological effects of delaying puberty. Its notable that theres no control group.
Canadian feminist Meghan Murphy speaks out against the lack of debate. Because representation matters, a call goes outnot to castcis women as trans.
Jill SollowaysTransparentcomes underfirefor not being woke enough.
A male to female detransitionerspeaks. TheNew York Timesadmitsthat scientists have no conclusive explanation for what causes some people to feel dissonance between their gender identity and aspects of their anatomy.
Philosopher Slavoj iek gets called out for his claimthat the vision of social relations that sustains transgenderism is the so-called postgenderism: a social, political and cultural movement whose adherents advocate a voluntary abolition of gender, rendered possible by recent scientific progress in biotechnology and reproductive technologies.
The Womens March takes to the streets in Washington, DC, wearingtransphobic, pink pussy hats. Bill Maher and Milo Yiannopoulos misgender Jenner and are slammedby Dan Savage.Neuterbecomes a thing, so does drilling down into biology to determine that sex is not binary in otherspecies. Which it is, really.
Stonewall UKs Rachel Steinconfirmsthat being trans is about an innate sense of self. To imply anything other than this is reductive and hurtful to many trans people who are only trying to live life as their authentic selves.
Thegender spectrumemerges.
Trans advocatessuggestthatprevious restrictions on transing kids be eased so that children under 16 years old can begin hormone therapy in order to physically transform their bodies.
Teachers socially trans kidswithout parents consent. Jazz Jenningss book I Am Jazzis acontroversialpick for kindergarten story time.
Radical feministsspeak outagainst transing kids. One lady istrans species.And trans affirmation is noweveryones job.Topshopopensfitting rooms to trans women. Theres money in them there trans.
The Department of Justice reverses the Obama era directives andsaysthat sex means only biologically male or female.
Katie Herzogwritesabout detransitioners, and gets intense heat for it. Debra Sohsaysthat the entire gender conversation has brain science wrong.
We will change our bodies however we want, theTrans Health Manifestoinsists. We will have universally accessible and freely available hormones & blockers, surgical procedures, and any other relevant treatments and therapies.
The real question is: how does a female bodied gay mannavigate Grindr?
Who could have guessed, even a decade ago, that in 2018 the word woman would be treated as an expletive? asks Joanna Williams in Britains PC-bible theNew Statesman.
The Gender Recognition Act allows for self-ID in the UK. The NHSmust offerfertility services to those looking to remove their genitals.Britain;s Labour party alienates gender-critical feminists by stating that self-ID is all thats required to be on Laboursshort listof women candidates. Women try to meet and talk about this mess, but their events arecanceleddue to trans protests.
UK Schools policy comes underfirefor insisting that all kids have a gender identity. Girl Guides inclusion policycalled outas anti-girl. Amother of fouris interrogated by the police for referring to male to female trans surgery as castration on Twitter. The mere concept ofdebating trans becomes transphobic.
Jess Bradley, the first elected Trans Officer in the UK National Union of Student, says I self-identify as a non-binary woman, I dont believe there is such a thing as a real woman. Male bodied trans person Rachel McKinnonwinsa womens cycling race.
Bill B-16 isadoptedin Canada. This effectively redefines what it means to be a woman from something biological to something defined by external appearance. A Toronto womens shelter admits a male bodied trans person, and an abused womansues.
In academia, Camille Paglia says sex change is impossible. Jordan Peterson is almost fired from the University of Toronto for refusing to go along with compelled speech for pronouns. There are callsfor colleges to let trans athletes play on their chosen gender.
Heather Brunskell-Evans and Michele Moores bookTransgender Children and Young People: Born In Your Own Bodyisrejectedby trans activists. Oxfordbansgender critical voices. Lisa Littmans academic paper on Rapid Onset Gender Dysphoria is pulled from Plos One for being transphobic. Jesse Singal writes about gender confused youth inthe Atlantic, and takes masses of abuse for it. Reports emerge on the danger in the drugs used tocastratechildren, and concerns thattransing is homophobia.
TheParis Reviewadvocates for atrans literary canon. No one buys theParis Review.
Trans surgeries dont always have an amazingresult.YettheAmerican Academy of Pediatriciansasserts thattransgender kids know their genderas clearly and consistently as their developmentally equivalent peers and that theres no need for watchful waiting.Trans toyscome to market.
TheNew York Timessayssex doesnt have anything to do with reproductive organs. Researchclaimsthat gender dysphoric kids show functional brain characteristics that are typical of their desired gender.
US prisonsopposetrans inmates in womens prisons. Canadian prisonsallowprisoners to be housed according to gender identity.
How much longer must transgender people continue to participate in public conversations about whether or not we know our own souls? Jennifer Finney Boylanasksin theNew York Times equating gender to a religious belief. Quillettemakes a splash by publishing opposition to the trans agenda, even fromtrans persons.
The question of how tofuck trans lesbiansis a thing. So isgirldick,how to eat out a non-op trans woman, andrewriting gay historyto be trans. Andrea Long Chu says shewont be happywith her new coochie, but she should get one anyway. Andtrans lesbiansreally have trouble dating.
Cis women areasked to do more for trans women, becauseit costs you zero dollars to be nice. Cis peoplewont date trans people, and lesbians decide to get the L outof LGBT.
Twitterprohibitsmisgendering and deadnaming to curtail anti-trans abuse. Meghan Murphy isbanned from Twitter for misgendering Jessica Yaniv, a male-bodied trans woman a transvestite, in traditional terms who wants to force immigrant women to wax her balls.
Trans English arrives, withtonsof new words for gender.Trans kidsknowwho they are, and its eitheraffirmationor death if you disagree.
Self-IDcomes to New Hampshire. Trans model Munroe Bergdorf ischosento speak by the London chapter of the globalWomens March. New York goesall-inon bathrooms and the abolition of women only spaces. South Dakotasayslet trans kids compete in sports
The Vancouver Rape Relief and Womens Shelterloses municipal funding after refusing to accept trans women. Morgane Oger wins a Human Rights Tribunal againstChristian activist Bill Whatcott after he distributedflyers disparaging herfor being a trans woman. A woman isarrestedfor referring to a transgender woman as a man online.
Liberal womenspeak on trans issues atthe Heritage Foundation, because they have beenabandonedby the left.
Butfacial recognitiondoesnt get trans. Neither dostraight men. Tennis legend Marina Navratilovaopposesmen in womens sports.
Even though thequick transingof kids is obviously a terrible idea, itsnot OKto talk about detransitioning. But girls start pushingbackon the locker room thing. So dograndmothers.
Students in the English town of Brighton are issued with stickers on which they write their preferredpronouns. Transtoolkitsarrive. Experts say that there has been aglobal surgein young people presenting to gender clinics. This mirrors the huge rise in referrals to the Gids, up from 94 to 2,519 since 2010.
Cosmopublishes a detailed account ofbottom surgery.
Trans advocatesdecrymental health screening prior to accessing cross-sex hormones. Trans offendersseek rightto remove crimes committed under previous gender. Hayden Patterson, held in womens prison in Canada, doesnt think she should have toact femaleto stay.Womb transplantsso men can bear children might be a thing. Elizabeth Warrenstatesher pronouns.
The firsttrans prison unitopens in the UK. In the US, a trans sex offender ismovedto womens prison. The World Health Organizationreclassestrans as not actually a mental health condition. Jessica Yaniv brings acasein Human Rights Tribunal against independent aestheticians who wouldnt wax her balls. She loses.
The winners of womens high school track and fieldcompetitionsin Connecticut are male bodied. In Australia, newguidelines encourage sporting organizationsto permit transgender and non-binary athletes to compete against members of the opposite sex. Laurel Hubbard wins gold in womens weightlifting in the Pacific Games, to the dismayof the president of Samoa.
The International Olympic Commissionconsidersrule changes to allow men to compete as women, but hits asnag. Womens rugby is toodangerousfor women once men get involved. A male runner is the female NCAAathlete of the week. But girlsspeak out: Female athletes around the globe feel that womens sports is no longersustainable.
Trans employment case goes to theSupreme Court. Trans guides come out for kids inQuebecandNew York City, as well as thegender unicorn. As domedical riskson chest binding, and thepushbackagainst that. Parental rights are chucked byAustralia, and courts in the US fromArizonatoTexastoVermont.
Puberty blockers arenota panacea. But kids are still beingfast trackedin the UK. Gender cliniciansrevealthey have tried to raise the alarm. Detransitioners start to make somenoise. Parents areaskedto resist the doctors.
It turns out the rhetoric about the trans murder epidemic isnot exactly true. Trans is apony tail. Not onlywomenget periods. Theresno such thingas biological sex. And not dating trans people isdiscriminatory.
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The 2010s were the decade of trans - The Spectator USA
How to Manage Stress with Laughter – Thrive Global
They say that laughter is the best medicine and while many medical professionals would surely believe they have at least a few remedies that can top laughter, it turns out that in many ways, laughter really does help your mental (and physical) health.
When you look at the many benefits that laughter can bring to your emotional life, you might want to consider seeking out ways that you can laugh more on the daily.
Everywhere from the renowned Mayo Clinic to Dr. Hunter Doherty Patch Adams and his Gesundheit! Institute have studied ways in which laughing can be linked to stress relief. This concept has created a whole branch of study known as Gelotology where researchers look for answers as to how laughter affects different people. Those who have embarked on this kind of research have discovered reasons as to why the phenomenon of laughing is so helpful for physical and mental health.
Laughing stimulates endorphins: The brain stimulants that fill the happiness center arent just excited when you find something funny. According to evolutionary psychologist Robin Dunbar, in an article for the New York Times, the actual physical action of laughing triggers endorphins as well as a connection between people. This effect, Dr. Dunbar found, leads to improved pain resistance as well as creating a great stress relief system for you. This means that just the act of smiling triggers a positive stress-reducing response.
Laughing reduces stress hormones: The stress hormone known as cortisol is decreased by laughter, because the action of laughing improves circulation and adds oxygen to the system, in effect, flushing out your stress. In a study by Lee Burk at Loma Linda University in California, they discovered that 30 minutes after watching humorous videos, participants of a study demonstrated 39% lessened cortisol levels.
Laughter fights depression: Beyond just the rush of endorphins, laughing creates a cocktail of chemical reactions in your brain including adrenaline and serotonin that has been shown to help with depression in general. Because these are chemicals that those that suffer from depression tend to have in lessened degrees, laughter has actually been used in treatment. For those of us who just get blue every once in a while, the same kind of therapy can do a world of good.
What makes you laugh? Biting satire, slapstick comedy, romantic misadventures? If you know what you like, its a great idea for your mental state to seek out your favorite comedy when trying to relieve stress. Whether youre a grad student getting their Master of Science in Nursing or a manager feeling stressed at work, just small doses of humor during the day can revive your spirit and give you physical benefits as well.
Get your comedy on social: following funny Instagram profiles, or people that aggregate humorous memes can give you bite-sized comedy moments that will allow you to get through your day with less stress. Give yourself a chance to check in with these periodically, particularly after a stressful activity.
Listen to comedy in your free time: Millions of people quote that stress bookends their workdays because of a crazy commute. Combat this stress specifically with comedy podcasts that allow you to be distracted from the crush of humanity that makes commuting so anxiety-inducing.
Get funny with exercise: The gym is a place where you could also use improved circulation and more oxygenated blood. Adding a laugh to your gym routine can potentially garner better results. In fact, there is a laughter based yoga practice that trains the body to be more open to this phenomenon, thus creating improved health.
Join a comedy class: comedy practitioners often quote their work as what gives them a stress-relieving boost. You can learn to be funny too! The action of taking an improv or stand-up comedy class will give you a chance to blow off steam and allow you the space to work on focusing on your own brand of humor.
Seek out comedy after stressful situations: When you are stressed, you may not feel like a laugh, but actively looking for the comedy section on your favorite streaming service will be a great way to relieve your stress.
Meet/talk with old friends: Often your old friends have the best ways to connect with you about the funny things that happened in your life. Theres nothing like shared humorous experiences and inside jokes to bring on a flood of positive emotions that can destress and help your mental health.
Theres nothing funny about stress. It can cause serious mental and physical harm including cardiac illness. Seeking out ways to relieve stress with humor, however, can have physically and emotionally positive effects. So dont forget to go and have a laugh, its good for you!
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How to Manage Stress with Laughter - Thrive Global
We’re Memphis Feminists and We’re Taking Birth Back – Ms. Magazine
Next year, CHOICES Memphis Center for Reproductive Health will open the first non-profit clinic in the U.S. providing both birth and abortion services under the same roof.
The road to a truly comprehensive reproductive health practice has been long, winding and full of potholes. I could not be more proud that in April, well finally get there.
I joined CHOICES as Executive Director in 2009 after a 15-year career in arts administration.Although I was an experienced non-profit executive, I was clearly entering a different world.Where was the mailing list?What was the marketing plan?
Although the clinic was providing safe medical care by a compassionate team, it had a precarious business model and was isolated from the rest of the healthcare community.That isolation combined with the political climate in the south kept the organization stuck in what felt like a vulnerable and dangerous place.
As I began to ask about the clinics history and operations and to attend conferences with other abortion providers, I understood that this isolation was primarily the result of anti-choice strategy. The care was so stigmatized that many physicians refused to perform the procedure out of fear of repercussions, both professional and physical.As a result, most abortion providers tended to work in stand-alone, abortion-only clinics with little to no interaction between them and other healthcare providers, hospitals or community groups.
At the same time, I was so impressed by the patient-centered and respectful care CHOICES provided to our patients. I remember thinking that everyone deserved this type of care. We soon started asking ourselves what else we could provide, and who else we could serve.
The private fertility practices in Memphis at this time would not take patients who were not married, leaving single people and same sex couples with no options for fertility helpsour nurse midwife began offering basic fertility assistance services.We added family planning for persons living with HIV, another population whose reproductive needs and preferences had been ignored or dismissed.We saw a need for hormone replacement services and wellness checkups for persons of transgender experience, so we added those services too. With these additions, we began expanding the scope and definition of reproductive health care beyond abortion and contraception.
As CHOICES grew, we consciously increased our involvement in the larger Memphis healthcare community.I started attending any local meeting that had health in its titleconferences on diabetes, hypertension and discussions of payment changes in the insurance industry.I introduced myself in these groups and spoke with pride about CHOICES work.
One day, when I was searching for stock photos for our website, and was mostly seeing many pictures of happy mothers and babies, I had another thought: Wait a minute. Why do they get all the happy pictures?Birth is part of feminist health care. We should take that back.
A few months later, the CHOICES Board of Directors approved adding prenatal care and birth services to the organizations strategic plan.
We understood that the people who have abortions and the people who give birth are the same people, because the majority of our abortion patients were mothers.And as we began to learn more about the maternity system in the U.S., we found that, unlike many other developed countries, U.S. caesarean rates were skyrocketing. Other medical interventions were also on the rise but the outcomes for moms and babies were getting worseespecially for people of color. We learned that black women were three to four times more likely to die in childbirth than white women. It was clear that birthing women of color were either not being seen or heard, or else their stated intentions and desires were being discounted.
We learned that midwifery provided another modelone that was more personal and more relationship-based, much like the abortion care that we were already providing. While Memphis had some outstanding home-birth midwives, it did not have a birthing center, and soon, bringing this choice to birthing people, especially to people of color, became a critical part of our mission.Off we went, on a $5 million dollar capital campaign.
Our inclusion of birth services also diversifies our revenue stream.With the current make-up of the United States Supreme Court, the ability of practices like CHOICES to provide abortion care hangs on a thread.We watched powerless just a few years ago while dozens of abortion-providing clinics closed in Texas while awaiting an ultimately positive judgement from the Supreme Court. We understood then that you have to be able to stay open in order to fight bad laws.By diversifying our services, we plan to be able to stay and fight, should providing abortion become illegal or impossible.
CHOICES mission is to provide patient-centered medical care and champion sexual and reproductive rights.Our vision is a world where sexual and reproductive healthcare is recognized as an essential human right.
Our new center hasnt opened yet, but we have already changed perceptions in our community.Organizations that once would have hesitated to work with an abortion provider are building professional partnerships with our midwifery program. Patients here for an abortion have asked to speak to a midwife and ultimately decided to continue their pregnancies.At least one midwifery patient, after having access to truly unbiased counseling, decided to terminate her pregnancy.
People are making their own CHOICESand we are here to support them.
Click here to support CHOICES.
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We're Memphis Feminists and We're Taking Birth Back - Ms. Magazine