Drawing by Nathaniel St. Clair

An article published in the Proceedings of the National Academy of Sciences recently argued that more species are going extinct due to human activity than occurred 66 million years ago, when an asteroid or similar hit the Earth.

Much less discussed is US President Donald Trumps (read: the military-industrial-complexs) Space Force, which Trump again championed at a recent address to the Kennedy Space Center, Florida. Space domination is Americas destiny, he told the audience. Referring to the protests that broke out across the US and the world, triggered by the slow suffocation on camera by a white cop of the unarmed, handcuffed black man, George Floyd, Trump said: I will not allow angry mobs to dominateunless they are angry mobs of police.

But what about calm mobs? The mob of military corporatists setting US weapons policy is calmly seeking to dominate space and thus the world. Trump went on to say: we will ensure a future of American dominance in space. This comes at a time when the US taxpayer is predicted to spend nearly half a trillion dollars over the next decade upgrading Americas aging nuclear weapons. The Space Force is integrating in various waystracking, surveillance, sensingwith the triad of nukes on land, in the air, and at sea.

PAVING THE WAY

In January 2017, the newly-unelected President Trump (he lost the popular vote by 2.9m), ordered the Department of Defense to conduct a Nuclear Posture Review. The document published a year later makes clear that the US possesses nuclear weapons, in part, so that our diplomats continue to speak from a position of strength on matters of war and peace. The Nuclear Posture Review cites Russia as the evil menace against which the US must defend by renewing its nuclear stockpiles.

But a Congressional Research Service report cites the view of US nuclear strategists who think that Russia has adopted an escalate to de-escalate strategy, where it might threaten to use nuclear weapons if it were losing a conflict with a NATO member, in an effort to convince the United States and its NATO allies to withdraw from the conflict. It notes that Russias modernization program began in the early-2000s. We might add that this was a couple of years after the US committed itself Full Spectrum Dominance of land, sea, air, and space. It was also around the time that the Bush II administration (2001-2009, which also lost the popular vote by half a million) pulled out of the Anti-Ballistic Missile Treaty 1972.

Arms Control Today reports that Trumps withdrawal from the Intermediate-Range Nuclear Forces (INF) Treaty 1987 leaves just the 2010 New Strategic Arms Reduction Treaty (New START) in place to limit U.S. and Russian nuclear weapons deployments. It notes that START 2010 is due to expire in February 2021. Moscow professed to want to negotiate instead of having the US simply withdraw. It then reiterated Russias commitments to match any US modernization and expansion of nuclear weapons. This is great for the US and Russian arms industries, but not so good for the prospects of human survival.

Part of the reason for withdrawing from the INF, according to US Defense Secretary Mark Esper, is to develop weapons to threaten China; though, of course, Esper puts it in different words, speaking instead of how great the development of an intermediate-range conventional weapon would be to the [Pacific Command] theater.

NUKES IN SPACE

On February 4th-5th, the Air Force Global Strike Command and 30th Space Wing test-launched the nuclear-capable Minuteman III intercontinental ballistic missile. The Space Force describes the ICBM as a unique portion of the Air Force Global Strike Command (AFGSC) nuclear enterprise.

First deployed in 1979, the W78 nuclear warhead is being renewed at a cost to US taxpayers of $8.6 billion. The renewal program began under Obama in 2010. It is scheduled for deployment in 2030 and will be renamed W78-1. The W78-1 is designed to be carried by the Minuteman III ICBM, recently tested by the AFGSC in collaboration with the Space Force and 30th Space Wing. Meanwhile, there are other ominous developments afoot.

In 2019, the Missile Defense Review advocated for placing interceptors, which can equally mean first-strike missiles, in space: Space-basing may increase the overall likelihood of successfully intercepting offensive missiles, the document claims. It can reduce the number of U.S. defensive interceptors required to do so, and potentially destroy offensive missiles over the attackers territory rather than the targeted state.

At the end of May 2020, Raytheons Missiles and Defense branch offered a job with secret clearance to engineers with expertise in radiation effects. The job calls for radiation hardening designs for missile defense interceptors. Interceptors are well-known by strategists to be, dual-use, potential first-strike weapons. We are executing programs and investing in systems designed to work in nuclear weapons and space environments, the document says. The job description mentions interceptors, which, if the authors of the Missile Defense Review have their way, could end up being based in space.

UPGRADES

Under the Stockpile Stewardship Program, Los Alamos no longer detonates nuclear weapons to test them, relying instead on non-nuclear tests and computer simulations. The Lab maintains old nukes via the Life Extension Program: ironic, given that the weapons do little other than threaten death. The LEP involves the analysis, replacement, and refurbishment of components.

The B61-3, -4, -7, and 11 nuclear gravity bombs are deployed to US and NATO bases. The B61 has been in service for 50 years, making it the oldest and most versatile weapon in the enduring U.S. stockpile. Designed and engineered at Los Alamos and Sandia National Laboratories, the Life Extension Program will keep the device in service for an additional 20 years. The B61-12 is being certified for delivery by current strategic and dual-capable aircraft, as well as future aircraft platforms. If we are interested in survival as a species, the dual-use element is problematic because Russian, Chinese, or other adversaries can never be sure whether the given bomber plane in or near their airspace is carrying nuclear weapons. This puts their militaries on high-alert and increases the likelihood of escalation through misunderstanding.

The W88 nuclear warheads Life Extension Program (LEP) started in 2012, again under Obama. The W88 came into service in 1988 with the Trident II D5 submarine-launched ballistic missile. The LEP will replace the arming, firing, and fusion system, and refreshes the weapons conventional high explosives, for safety reasons, of course. The LEP is compartmentalized across several labs. Los Alamos is in charge of W76-2 mod, a LEP for another Trident II D5 submarine-launched ballistic missile.

The W76-1 produces a high-yield and is, counterintuitively, safer for the world in some ways because enemies know that they will be obliterated and are therefore less likely to engage in the kind of warfighting that can lead to escalation. First produced in 2019 at the Pantex Plant in Amarillo, the W76-2 on the other hand produces a lower-yield explosion, blurring the lines between nuclear and non-nuclear war. Lower-yield weapons are more tempting for commanders and world leaders to use, but they risk retaliation from states with high-yield weapons and thus uncontrollable nuclear escalation. Los Alamos describes the W76-2 mod as a milestone in support of a national security initiative requested by the president in the 2018 Nuclear Posture Review.

The W80-1 is being extended at Lawrence Livermore via the W80-4, which will be ready by 2031. The scientists explain that the insensitive high explosive, triaminotrinitrobenzene (TATB), will be used for the warheads main charge. Engineers and chemists at Lawrence Livermore are helping to restart the TATB production process after 30 years of dormancy.

In April 2020, Raytheon won the contract to develop the Long Range Standoff Weapon (LRSO) for the US Air Force, on which the W80-4 will be placed. The LRSO will be capable of both nuclear and conventional strikes, says Defense News, which means that Russia and China will be on high-alert and prone to escalation in error, as the article later admits.

CONCLUSION: DIRECT THAT ENERGY

As Extinction Rebellion largely obeys COVID lockdown, Black Lives Matter and other solidarity groups take to the streets nationally and internationally. Militarized police push young, unarmed women to the ground, use their shields to knock over old men, and even fire their paint guns at people standing in their doorways filming. We have an out-of-control, predatory neoliberal economic system, a powder keg of 40 million unemployed Americans, a climate heating up by the day, causing wildfires in the Arctic, and a grim swing towards a new kind of buffoonish authoritarianism, with Bolsonaro in Brazil, BoJo the Clown in the UK, and the manic Narcissist-in-Chief in the White House running the most powerful nation on Earth.

As if all of this wasnt bad enough, world-threatening nukes are being modernized and incrementally based in space. We need a broad left coalition of Extinction Rebellion, Black Lives Matter, and a revived anti-nuclear campaign to team up with anti-space-weapons networks to, if not end this madness, at least mitigate it. Unless we succeed, we might not be here to rebel against our extinction.

Originally posted here:
Nukes in Space: the Extinction Rebellion Yet to Be - CounterPunch.org - CounterPunch

Recommendation and review posted by Bethany Smith

Global Wellness Supplements Market study with 100+ market data Tables, Pie Chat, Graphs & Figures is now released by Data Bridge Market Research. The report presents a complete assessment of the Market covering future trend, current growth factors, attentive opinions, facts, and industry validated market data forecast till 2026. Delivering the key insights pertaining to this industry, the report provides an in-depth analysis of the latest trends, present and future business scenario, market size and share of Major Players such asLife Extension, OPTAVIA, Beachbody, LLC, Natures Sunshine Products, Inc, Organo Gold., Thrive Life, LLC, PhytoscienceTrevo, Oriflame Cosmetics AG, Melaleuca Inc, Shaklee Corporation, Arbonne International, LLC., Forever Living.com, L.L.C, Juice Plus+.

TheGlobal Wellness Supplements Marketis expected to reach USD 384.30 Billion by 2025, from USD 204.72 million in 2017 growing at a CAGR of 6.5% during the forecast period of 2018 to 2025. The upcoming market report contains data for historic year 2016, the base year of calculation is 2017 and the forecast period is 2018 to 2025.

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Global Wellness Supplements Market By Product (Dietary Supplements, Functional/Fortified Food & Beverages and Food intolerance products and Dermo-Cosmetic Skin Essentials), By Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) Industry Trends and Forecast to 2025

Major Market Competitors/Players:

Some of the major players operating in the global wellness supplement market are Life Extension, OPTAVIA, Beachbody, LLC, Natures Sunshine Products, Inc, Organo Gold., Thrive Life, LLC, Phytoscience Trvo, Oriflame Cosmetics AG, Melaleuca Inc, Shaklee Corporation, Arbonne International, LLC., Forever Living.com, L.L.C, Juice Plus+, Herbalife International of America, Inc, and Isagenix Worldwide LLC, Nikken Inc., Wellness Resources, Inc., The Daily Wellness Company, Otsuka Holdings Co. Ltd, Glanbia plc, Nestle, Nuskin, USANA Health Sciences, Inc. A and among others

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Market Segmentation:Global Wellness Supplements Market

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PROFESSIONAL ANALYSIS OF HOW COVID-19 IS IMPACTING THE GLOBAL WELLNESS SUPPLEMENTS MARKET | LIFE EXTENSION, OPTAVIA, BEACHBODY, LLC, NATURE'S SUNSHINE...

Recommendation and review posted by Bethany Smith

On Tuesday, June 16, 2020,Wade Chien, M.D., will discuss the exciting field of gene therapy research and its potential promise for treating some forms of hearing and balance disorders. There is no cure for hearing loss, although technologies such as hearing aids and cochlear implants can help some people hear better. Moreover, few options are available for those with chronic balance disorders. Scientists are seeking treatments to replace or repair damaged hair cells in the inner ear that are responsible for a range of hearing and balance disorders. Dr. Chiens lab is using gene therapy techniques in mice to try to stop the symptoms of these disordersand to treat or reverse damage to the inner ear caused by gene mutations.

This lecture is part of a series of talks led by researchers from the National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health, called Beyond the Lab, Understanding Communication Disorders. The speaker series is an opportunity for everyone inside and outside of the NIHadministrative staff, support staff, scientists, and the publicto learn about the NIDCDs recent advances in communication disorders, conditions that significantly affect about 20 percent of U.S. adults during their lifetime.

Enhanced microscopic image showing hair-like projections (stereocilia) on the sensory hair cells in the inner ear of a mouse model treated with inner ear gene therapy. The mouse has a genetic form of deafness that causes the stereocilia to be short and defective. Gene therapy elongated the stereocilia and improved hearing.

Source: Kevin Isgrig, NIDCD

Dr. Chien is an NIDCD otolaryngology (diseases of the ear and throat) surgeon-scientist, and principal investigator of the NIDCD Inner Ear Gene Therapy Program. Dr. Chiens lab uses mouse models of hearing and balance disorders to test how sensory hair cells in the inner ear respond to gene therapy. He will discuss exciting recent work from his lab on inner ear gene therapy for deafness and dizziness.

Hearing loss is central to the mission of the NIDCD. Researchers have identified dozens of genetic factors associated with hearing loss.

This live webcast will be captioned and will be available for later viewing. Individuals with disabilities who need sign language interpreting and/or other reasonable accommodations to participate in this eventshould contact Lonnie Lisle (telephone: 240-464-4355) and/or the Federal Relay (800-877-8339) by June 11.

About the Speaker

Wade Chien, M.D., joined the NIDCD as an investigator in the Otolaryngology Surgeon-Scientist Program in 2011. He is also an associate professorin the department of otolaryngology-head and neck surgery at the Johns Hopkins School of Medicine. He received bachelor's degrees in biology and music from Brandeis University and an M.D. from the University of Southern California Keck School of Medicine. He completed otolaryngology residency training in the Harvard Combined Otolaryngology Residency Program at Massachusetts Eye and Ear Infirmary, and a neurotology fellowship at the Johns Hopkins Hospital. He is an alumnus of the Howard Hughes Medical Institute-National Institutes of Health Research Scholars Program, during which he worked with Dr. Gerald Fischbach to study the effects of neurotrophins in the neuromuscular junction. He is also a recipient of an NIH T32 training grant in residency, during which he studied middle ear mechanics under the guidance of Dr. Saumil Merchant and Dr. John Rosowski.

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June 16 Beyond the Lab speaker series: The promise of gene ...

Recommendation and review posted by Bethany Smith

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--CANbridge Pharmaceuticals Inc., a biopharmaceutical company developing innovative drug candidates to treat underserved medical conditions, announced that it has initiated a research program with the Horae Gene Therapy Center at the UMass Medical School, in Worcester, MA, for gene therapy research in rare genetic diseases, with a focus on neuromuscular conditions. The research program will be under the direction of Guangping Gao, PhD, Co-Director, Li Weibo Institute for Rare Diseases Research, Director, the Horae Gene Therapy Center and Viral Vector Core, Professor of Microbiology and Physiological Systems and Penelope Booth Rockwell Professor in Biomedical Research at UMass Medical School. Dr. Gao is a groundbreaking gene therapy researcher who played a key role in the discovery and characterization of adeno-associated virus (AAV) serotypes now widely used in the field.

CANbridge also announced the addition of Guangping Gao, PhD. and Mark Bamforth, an industry veteran and founder and former CEO of Brammer Bio, to its recently-expanded Strategic Advisory Board.

This collaboration with the Horae Gene Therapy Center at UMass, a pioneer in gene therapy research, affords CANbridge the potential to extend our rare disease pipeline by integrating next-generation technology as we advance as a leader in the treatment of rare diseases, said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals Inc. We are thrilled to be partnering with such a world-class institution.

As a longtime leader in the development of gene therapies for rare disease, with expertise in both capsid and genome engineering, Dr. Gao is the ideal partner for CANbridge as we expand our therapeutic capacity in rare genetic diseases, said Richard J. Gregory, PhD, Acting Chief Scientific Officer, CANbridge Pharmaceuticals Inc.

On behalf of everyone at CANbridge, Im very pleased to welcome Guangping Gao and Mark Bamforth, each widely recognized as true global leaders in the broad areas of gene therapy science and manufacturing, to our Strategic Advisory Board, said Jim Geraghty, CANbridge Pharmaceuticals Advisory Board Chair. Together with Mark Goldberg and Rich Gregory, also recognized biotechnology leaders, they give CANbridge an unparalleled foundation for developing breakthrough therapies for patients in China and around the world.

About the Horae Gene Therapy Center at UMass Medical School

The faculty of the Horae Gene Therapy Center is dedicated to developing therapeutic approaches for rare inherited disease for which there is no cure. We utilize state of the art technologies to either genetically modulate mutated genes that produce disease-causing proteins, or introduce a healthy copy of a gene if the mutation results in a non-functional protein.

The Horae Gene Therapy Center faculty is interdisciplinary, including members from the departments of Pediatrics, Microbiology & Physiological Systems, Biochemistry & Molecular Pharmacology, Neurology, Medicine and Ophthalmology. Physicians and PhDs work together to address the medical needs of rare diseases, such as Alpha 1-Antitrypsin Deficiency, Canavan Disease, Tay-Sachs and Sandhoff diseases, Retinitis Pigmentosa, Cystic fibrosis, Lou Gehrig's disease, TNNT1 nemaline myopathy, Rett syndrome, N-Gly 1 deficiency, Pitt-Hopkins syndrome, Marple Syrup Urine Disease, Sialidosis, GM3 synthase deficiency, Huntington's disease, ALS and others. More common diseases such as cardiac arrhythmia and hypercholesterolemia are also investigated. The hope is to treat a wide spectrum of diseases by various gene therapeutic approaches. Additionally, the University of Massachusetts Medical School conducts clinical trials on site and some of these trials are conducted by the investigators at the Gene Therapy center.

About the University of Massachusetts Medical School

The mission of the University of Massachusetts Medical School is to advance the health and well-being of the people of the commonwealth and the world through pioneering education, research, public service and health care delivery.

For more information, visit http://www.umassmed.edu.

About CANbridge Pharmaceuticals Inc.

CANbridge Pharmaceuticals Inc. is a biopharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers, focusing on products that are unavailable or address unmet medical needs.

CANbridge has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases. In greater China, where it is a recognized leader in orphan diseases, CANbridge has an exclusive licensing agreement to commercialize Hunterase, an enzyme replacement therapy for the treatment of Hunter syndrome, developed by GC Pharma and marketed in more than ten countries worldwide. The CANbridge oncology portfolio includes exclusive rights to develop and commercialize Puma Biotechnologys NERLYNX (neratinib), which was recently approved in greater China, as well as rights to other novel candidates.

For more on CANbridge Pharmaceuticals Inc., please go to http://www.canbridgepharma.com.

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CANbridge Pharmaceuticals Enters Into Rare Disease Gene ...

Recommendation and review posted by Bethany Smith

The same day Oxford Biomedica signed a 5-year deal to make AstraZenecas Covid-19 vaccine, the UK gene therapy company announced they received word Sanofi was sending a couple of decade-old experimental drugs back to them.

In 2009, Sanofi and Biomedica slashed a co-development deal on TroVax, a cancer vaccine that had been one of the centerpieces of the then 14-year-old company. But the pair immediately replaced it with a deal, 8 years before the approval of Spark Therapeutics Luxturna, to develop gene therapies for two eye-related disorders.

Now, with little to show for it but a pair of very early studies, Sanofi is kicking the therapies back to Biomedica. The French drugmaker had already announced last year, amid an internal shakeup, that they were not interested in developing the drugs further, but what would happen to the therapies hung in the air.

In some ways, it still does. Biomedica wouldnt commit to progressing or retiring them. It wasnt even clear when Biomedica would regain the rights.

The timing of return of these programs and operational details are yet to be determined, the biotech said in a statement. However, when the rights to the two programs are returned, the group will undertake its own internal evaluation to determine the potential future for these programs and decide whether to commit further resources to them.

Biomedicas $100 million partnership with Sanofis rare blood disorder subsidiary Bioverativremains intact.

The two gene therapies are SAR422459, for treating a progressive macular disease called Stargardt disease, and SAR421869, for treating Ushers Syndrome, a disorder that can cause both vision and hearing loss. The Stargardt therapy began a Phase I/II study in France in 2011, but the study was ended prematurely last August after Sanofi reprioritized its pipeline. Although the study was designed to measure biological markers of efficacy, Sanofi included no such data when it posted results on clinicaltrials.gov earlier this year.

The therapy for Ushers Syndrome entered its Phase I/II study in 2012. That study was suspended in 2017 while Sanofi reviewed its pipeline and then also terminated last year.

If Biomedica considers the therapies to still have potential, its likely they will try to out-license them again. The company is built around partnerships, licensing out a few in-house candidates and helping manufacture Novartiss CAR-T therapy Kymriah and, as of yesterday, AstraZenecas Covid-19 vaccine. They areexplicitly not a commercial-stage biotech.All of the preclinical candidates on its website are listed as to be spun out, or out-licensed, and they run no clinical trials.

So the best question may be not whether Biomedica sees potential, but if anyone else does.

Social: Shutterstock

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Sanofi sends a pair of gene therapies back to Oxford Biomedica. Are they salvageable? - Endpoints News

Recommendation and review posted by Bethany Smith

Global Gene Therapy for Inherited Genetic Disorders Market: Trends Estimates High Demand by 2027

The Gene Therapy for Inherited Genetic Disorders Market 2020 report includes the market strategy, market orientation, expert opinion and knowledgeable information. The Gene Therapy for Inherited Genetic Disorders Industry Report is an in-depth study analyzing the current state of the Gene Therapy for Inherited Genetic Disorders Market. It provides a brief overview of the market focusing on definitions, classifications, product specifications, manufacturing processes, cost structures, market segmentation, end-use applications and industry chain analysis. The study on Gene Therapy for Inherited Genetic Disorders Market provides analysis of market covering the industry trends, recent developments in the market and competitive landscape.

It takes into account the CAGR, value, volume, revenue, production, consumption, sales, manufacturing cost, prices, and other key factors related to the global Gene Therapy for Inherited Genetic Disorders market. All findings and data on the global Gene Therapy for Inherited Genetic Disorders market provided in the report are calculated, gathered, and verified using advanced and reliable primary and secondary research sources. The regional analysis offered in the report will help you to identify key opportunities of the global Gene Therapy for Inherited Genetic Disorders market available in different regions and countries.

The final report will add the analysis of the Impact of Covid-19 in this report Gene Therapy for Inherited Genetic Disorders industry.

Some of The Companies Competing in The Gene Therapy for Inherited Genetic Disorders Market are: BioMarin Pharmaceutical Inc., bluebird bio Inc., Novartis AG, Orchard Therapeutics Plc, Spark Therapeutics Inc., and

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The report scrutinizes different business approaches and frameworks that pave the way for success in businesses. The report used Porters five techniques for analyzing the Gene Therapy for Inherited Genetic Disorders Market; it also offers the examination of the global market. To make the report more potent and easy to understand, it consists of info graphics and diagrams. Furthermore, it has different policies and improvement plans which are presented in summary. It analyzes the technical barriers, other issues, and cost-effectiveness affecting the market.

Global Gene Therapy for Inherited Genetic Disorders Market Research Report 2020 carries in-depth case studies on the various countries which are involved in the Gene Therapy for Inherited Genetic Disorders market. The report is segmented according to usage wherever applicable and the report offers all this information for all major countries and associations. It offers an analysis of the technical barriers, other issues, and cost-effectiveness affecting the market. Important contents analyzed and discussed in the report include market size, operation situation, and current & future development trends of the market, market segments, business development, and consumption tendencies. Moreover, the report includes the list of major companies/competitors and their competition data that helps the user to determine their current position in the market and take corrective measures to maintain or increase their share holds.

What questions does the Gene Therapy for Inherited Genetic Disorders market report answer pertaining to the regional reach of the industry?

The report claims to split the regional scope of the Gene Therapy for Inherited Genetic Disorders market into North America, Europe, Asia-Pacific, South America & Middle East and Africa. Which among these regions has been touted to amass the largest market share over the anticipated duration

How do the sales figures look at present how does the sales scenario look for the future?

Considering the present scenario, how much revenue will each region attain by the end of the forecast period?

How much is the market share that each of these regions has accumulated presently

How much is the growth rate that each topography will depict over the predicted timeline

A short overview of the Gene Therapy for Inherited Genetic Disorders market scope:

Global market remuneration

Overall projected growth rate

Industry trends

Competitive scope

Product range

Application landscape

Supplier analysis

Marketing channel trends Now and later

Sales channel evaluation

Market Competition Trend

Market Concentration Rate

Reasons to Read this Report

This report provides pin-point analysis for changing competitive dynamics

It provides a forward looking perspective on different factors driving or restraining market growth

It provides a six-year forecast assessed on the basis of how the market is predicted to grow

It helps in understanding the key product segments and their future

It provides pin point analysis of changing competition dynamics and keeps you ahead of competitors

It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

TABLE OF CONTENT:

Chapter 1:Gene Therapy for Inherited Genetic Disorders Market Overview

Chapter 2: Global Economic Impact on Industry

Chapter 3:Gene Therapy for Inherited Genetic Disorders Market Competition by Manufacturers

Chapter 4: Global Production, Revenue (Value) by Region

Chapter 5: Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6: Global Production, Revenue (Value), Price Trend by Type

Chapter 7: Global Market Analysis by Application

Chapter 8: Manufacturing Cost Analysis

Chapter 9: Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10: Marketing Strategy Analysis, Distributors/Traders

Chapter 11: Gene Therapy for Inherited Genetic Disorders Market Effect Factors Analysis

Chapter 12: GlobalGene Therapy for Inherited Genetic Disorders Market Forecast to 2027

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Research on Gene Therapy for Inherited Genetic Disorders Market (impact of COVID-19) with Top Players: BioMarin Pharmaceutical Inc., bluebird bio...

Recommendation and review posted by Bethany Smith

Related ResearchSarepta Therapeutics Inc., a leader in precision genetic medicine for rare diseases, plans to invest over $30 million to expand its Gene Therapy Center of Excellence in Columbus, Ohio. The project is expected to create 100 new jobs.

Pending state approvals, Sarepta plans to open its new center in an 85,000-square-foot facility at 3435 Stelzer Road in Columbus. All employees currently operating out of the Companys Dublin, Ohio, office will transition to the new facility over time. Armed with the most advanced science in genetic medicine, the new center will allow Sarepta to lead the way in making Columbus an epicenter of gene therapy research and development. In addition to the new building, the companys investment will be used toward R&D equipment.

Sarepta is emerging as the world leader in gene therapy to treat and transform lives otherwise diminished and stolen by rare genetic disease. We are confident that gene therapy will revolutionize genetic medicine, and we chose Ohio for our Gene Therapy Center of Excellence because we believe Columbus will become a hub for genetic medicine innovation, said Sarepta President & CEO Doug Ingram. Our new center will strengthen the position of Columbus as a gene therapy leader, building on the advances of our long-standing partner, Nationwide Childrens Hospital.

We are proud to be the home of Sareptas new Gene Therapy Center of Excellence and to support their continued innovation within a critical field in medicine, said Columbus Mayor Andrew J. Ginther. The companys investment in Columbus is a testament to why our city and region are positioned to become the most important place in the world for gene therapy development.

From medical breakthroughs to cutting-edge technology, the Columbus Region is home to one of the top healthcare industries in the country. With several renowned healthcare systems and companies, including OhioHealth, Nationwide Childrens Hospital and Cardinal Health, the Columbus Region employs more than 45,000 in the industry. The Regions large pool of IT talent, combined with its well-established healthcare sector, makes it a hotbed for innovation.

Sarepta is one of the nations fastest growing biotechnology companies focused on the development of precision genetic medicines, said JobsOhio President and CEO J.P. Nauseef. With Ohio talent, Sarepta will advance its R&D of neuromuscular and central nervous system diseases at its new gene therapy R&D Center in the Columbus Region.

Founded in 1980, Sarepta develops genetic medicines to treat rare diseases, and currently has two approved products for Duchenne muscular dystrophy (DMD) and a pipeline of more than 40 treatments in development. The companys programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing.

Headquartered in Cambridge, Massachusetts, Sarepta has locations across four continents, and its current Central Ohio research facility in Dublin employs approximately 40 full-time workers.

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Sarepta Therapeutics Expands Gene Therapy Center of Excellence in Columbus, Ohio - Area Development Online

Recommendation and review posted by Bethany Smith

MINNEAPOLIS, June 10, 2020 /PRNewswire/ -- Be The Matchtoday announced the appointment of Amy Ronneberg as chief executive officer (CEO)the first female CEO for the organization. Ronneberg joined Be The Match in 2013 as chief financial officer (CFO) and chief of staff, and has served as acting CEO since February.

Be The Match is a non-profit organization that delivers cures to patients in need of life-saving blood stem cell therapy. The organization operates the national Be The Match Registry,the world's largest and most diverse listing of potential stem cell donors. As trusted leaders in advancing stem cell therapy, Be The Match also provides ground-breaking research, innovative technologies, patient support, and education so even more lives can be saved.

Around the same time Ronneberg joined Be The Match as CFO, she was diagnosed with breast cancer. Now cancer-free, she brings unique passion and perspective to her work.

"As a cancer survivor, I have personally felt what many other cancer patients and their loved ones encounter every day. My experience, the patients we serve, and our outstanding, dedicated employees are my motivation," Ronneberg said. "I am deeply honored to be selected to lead this organization and look forward to further advancing our commitment to providing equal outcomes for all. The recent pandemic has put a spotlight on healthcare inequalities, and we are uniquely positioned to address one glaring disparity that is affecting ethnically diverse patientsthat is the ability to find a matching donor. I look forward to leading our team in diversifying the registry and delivering more life-saving treatments to patients of all backgrounds."

After the Affordable Care Act was implemented, Ronneberg led a Be The Match budget restructure that netted a sustainable $50 million cost reduction and made marrow transplants more affordable. Those efforts and more earned her one of the Minneapolis/St. Paul Business Journal's 2016 CFO of the Year awards. Ronneberg also played a pivotal role in establishing Be The Match's operations in Mexico.

This spring, the Be The Match Board of Directors worked with an outside firm to identify the qualities needed in its next CEO and unanimously agreed that Ronneberg possesses all of them.

"Amy has the perfect blend of business experience, passion and health care expertise to lead Be The Match," said Chair of the Board David L. Porter, M.D. "She likes to say, 'patients first, employees always.' I applaud her commitment to carrying out our mission and putting people first."

Ronneberg is also responsible for Be The Match BioTherapies, which partners with global cell and gene therapy industry leaders to deliver high-quality, consistent and compliant therapies to patients in need. Under her guidance, Be The Match BioTherapies has invested in several therapeutics companies and launched an integrated supply chain platform called MatchSource.

Prior to joining Be The Match, Ronneberg spent 12 years at Capella Education Company where she served as chief accounting officer, vice president of finance and led enterprise-wide operations and customer service. She also worked for Ernst & Young as an audit manager.

Ronneberg has served on several boards and is currently on the board of Magenta Therapeutics (MGTA) and the Finance Committee for Allina Healthcare and the World Marrow Donor Association.

Ronneberg earned a Master of Business Administration from Capella University, Minneapolis, Minn. and a Bachelor of Business Administration in Accounting from University of Wisconsin-Eau Claire.

"Going through treatment with my husband and young children at my side made me a much stronger person, leader and decision maker," Ronneberg said. "Cancer is an unfortunate reality that millions of people have to face, but with support, hope and the right medical tools, it can be overcome."

About Be The MatchFor people with life-threatening blood cancerslike leukemia and lymphomaor other diseases, a cure exists. Be The Match connects patients with their donor match for a life-saving marrow or umbilical cord blood transplant. People can contribute to the cure as a member of the Be The Match Registry, financial contributor or volunteer. Be The Match provides patients and their families one-on-one support, education, and guidancebefore, during and after transplant.

Be The Match is operated by the National Marrow Donor Program (NMDP), a nonprofit organization that matches patients with donors, educates health care professionals and conducts research through its research program, CIBMTR (Center for International Blood and Marrow Transplant Research), so more lives can be saved. To learn more about the cure, visit BeTheMatch.orgor call 1 (800) MARROW-2.

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Be The Match Appoints Amy Ronneberg as Chief Executive Officer - Southernminn.com

Recommendation and review posted by Bethany Smith

The report covers the forecast and analysis of the Cell and Gene Therapy Consumables market on a global and regional level. The study provides historical data from 2015 to 2018 along with a forecast from 2019 to 2027 based on revenue (USD Million). The study includes drivers and restraints of the Cell and Gene Therapy Consumables market along with the impact they have on the demand over the forecast period. Additionally, the report includes the study of opportunities available in the Cell and Gene Therapy Consumables market on a global level.

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In order to give the users of this report a comprehensive view of the Cell and Gene Therapy Consumables market, we have included a competitive landscape and an analysis of Porters Five Forces model for the market. The study encompasses a market attractiveness analysis, wherein all the segments are bench marked based on their market size, growth rate, and general attractiveness.

The report provides company market share analysis to give a broader overview of the key players in the market. In addition, the report also covers key strategic developments of the market including acquisitions & mergers, new service & product launches, agreements, partnerships, collaborations & joint ventures, research & development, and regional expansion of major participants involved in the market on a global and regional basis.

The study provides a decisive view of the Cell and Gene Therapy Consumables market by segmenting the market based on product type, application/therapeutics, and regions. All the segments have been analyzed based on present and future trends and the market is estimated from 2019 to 2027. The regional segmentation includes the current and forecast demand for North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

A rise in the awareness about the gene & cell therapies will propel the market growth during the period from 2019 to 2027. Nevertheless, conducting randomized control tests will inhibit the expansion of the market during the forecast timeline. However, the growing trend for treating neurodegenerative ailments through the use of gene treatment will proliferate the market growth over the forecast period.

The expansion of the market during the forecast timespan is owing to the high frequency of chronic ailments including cancer and heart disorders. Apart from this, inflation in the occurrence of these disorders produces lucrative demand for enhanced therapies and this will culminate in the market demand over the forecast timespan.

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Based on the product type, the market is sectored into Kits & Buffers, Diagnostic Assay, Culture Medium, and Cryopreservation Media. Application/ Therapeutics- wise, the market for cell and gene therapy consumables are classified into Cardiovascular, Urology, Dermatology, Critical Care, Respiratory, Endocrine & Metabolic, Neuroscience, Hematology & Oncology, Obstetrics, Immunology, and Gastroenterology.

Some of the key players in the market include Amgen Inc., ATLANTA BIOLOGICALS, bluebird bio, Inc., Cook, Dendreon Pharmaceuticals, LLC, Fibrocell Science, Inc., General Electric, Kolon TissueGene, Inc., Orchard Therapeutics plc., Pfizer, Inc., PromoCell GmbH, RENOVA THERAPEUTICS, Sibiono GeneTech Co. Ltd., Spark Therapeutics, Inc., Vericel, Helixmith Co., Ltd., and Vitrolife.

About Kenneth Research

Kenneth Research is a reselling agency providing market research solutions in different verticals such as Automotive and Transportation, Chemicals and Materials, Healthcare, Food & Beverage and Consumer Packaged Goods, Semiconductors, Electronics & ICT, Packaging, and Others. Our portfolio includes set of market research insights such as market sizing and market forecasting, market share analysis and key positioning of the players (manufacturers, deals and distributors, etc), understanding the competitive landscape and their business at a ground level and many more. Our research experts deliver the offerings efficiently and effectively within a stipulated time. The market study provided by Kenneth Research helps the Industry veterans/investors to think and to act wisely in their overall strategy formulation

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Cell and Gene Therapy Consumables Market Top Key Players, Drivers and Trends to 2027 - Cole of Duty

Recommendation and review posted by Bethany Smith

The Global Gene Therapy Market was estimated to be valued at USD XX million in 2019 and is projected to reach USD XX million by 2026, at a CAGR of XX% during 2019 to 2026.

The market is primarily driven by increase in funding for R&D activities pertaining to gene therapy and increase in awareness regarding gene therapy.

In addition, increase in government support, ethical acceptance of gene therapy for cancer treatment, and rise in prevalence of cancer is likely to fuel the market growth.

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Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

Top Key Companies Analyzed inGlobal Gene Therapy Market are Novartis, Kite Pharma Inc., GlaxoSmithKline PLC, Spark Therapeutics Inc., Bluebird bio Inc., Genethon, Transgene SA, Applied Genetic Technologies Corporation, Oxford BioMedica and NewLink Genetics Corp

Key Benefit of This Report:

Global Gene Therapy Industry 2019 Market Research Report is spread across 121 pages and provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

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Target Audience:

Research Methodology:

The market is derived through extensive use of secondary, primary, in-house research followed by expert validation and third party perspective, such as, analyst reports of investment banks. The secondary research is the primary base of our study wherein we conducted extensive data mining, referring to verified data sources, such as, white papers, government and regulatory published articles, technical journals, trade magazines, and paid data sources.

For forecasting, regional demand & supply factors, recent investments, market dynamics including technical growth scenario, consumer behavior, and end use trends and dynamics, and production capacity were taken into consideration.

Different weightages have been assigned to these parameters and quantified their market impacts using the weighted average analysis to derive the market growth rate.

The market estimates and forecasts have been verified through exhaustive primary research with the Key Industry Participants (KIPs), which typically include:

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Major Points Covered in Table of Contents:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Global Gene Therapy Market Overview

5 Global Gene Therapy Market, by Vector

6 Global Gene Therapy Market, by Application

7 Global Gene Therapy Market by Region

8 Competitive Landscape

9 Company Profiles

10 Key Insights

Customization Service of the Report:Orian Research provides customisation of reports as per your need. This report can be personalised to meet your requirements. Get in touch with our sales team, who will guarantee you to get a report that suits your necessities.

About Us:Orian Research is one of the most comprehensive collections of market intelligence reports on the World Wide Web. Our reports repository boasts of over 500000+ industry and country research reports from over 100 top publishers. We continuously update our repository so as to provide our clients easy access to the worlds most complete and current database of expert insights on global industries, companies, and products. We also specialize in custom research in situations where our syndicate research offerings do not meet the specific requirements of our esteemed clients.

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COVID-19 Impact on Global Gene Therapy Industry 2020: Market Trends, Size, Share, Growth Applications, SWOT Analysis by Top Key Players and Forecast...

Recommendation and review posted by Bethany Smith

- Six-month data from low-dose cohort expected in Q4 2020

- IND amended to include Type I (infantile onset) patients and to evaluate a higher dose - Expect to initiate high-dose cohort in 2H 2020

NEW YORK and BASEL, Switzerland, June 08, 2020 (GLOBE NEWSWIRE) -- Axovant Gene Therapies Ltd. (NASDAQ: AXGT), a clinical-stage company developing innovative gene therapies for neurological diseases, today announced that it has completed enrollment in the low-dose cohort of the Phase 1/2 (Stage 1”) study for Type II (late infantile and juvenile onset) GM1 patients evaluating safety, tolerability, and exploratory measures of efficacy at a dose of 1.5x1013 vg/kg delivered intravenously. Currently, the study is on track to report 6-month data (n=5) from the low-dose cohort of the AXO-AAV-GM1 clinical trial by Q4 2020. Additionally, the investigational new drug (IND) filing has been amended to expand the program to include Type I (infantile) patients and to evaluate a 3-fold higher dose (4.5x1013 vg/kg). The Company expects to initiate dosing in the high-dose cohort, which will include both Type I and Type II patients, in the second half of 2020.

The successful enrollment of the low-dose cohort of the ongoing Phase 1/2 study amidst the COVID-19 pandemic speaks to the dedication of all involved and the significant unmet need that exists for these children,” said Dr. Gavin Corcoran, chief R&D officer. With an expanded study protocol that now includes infantile-onset patients, AXO-AAV-GM1 is the only gene therapy in development to include both Type I and Type II GM1 patients, populations of children who suffer from a deficiency in the same enzyme, -galactosidase. We are grateful for the collaboration and perseverance of the National Institutes of Health (NIH), patients, and their families to advance efforts towards finding a treatment for this devastating pediatric disease.”

This study is being conducted at the NIH under the direction of Dr. Cynthia Tifft, Deputy Clinical Director at the National Human Genome Research Institute (NHGRI) in collaboration with Axovant Gene Therapies. In late 2019, the Company presented an update from the first GM1 Type II child dosed with AXO-AAV-GM1 under an expanded access protocol who was observed to have clinically significant improvements from baseline gene transfer to six-month follow-up based on neurological exam, the Vineland-3 scale, Clinical Global Impression assessments, and nutritional status. In addition, AXO-AAV-GM1 was observed to be generally well-tolerated with no reports of serious adverse events related to the investigational gene therapy or intravenous administration of the vector.

GM1 gangliosidosis is a progressive and fatal pediatric lysosomal storage disorder caused by mutations in the GLB1 gene leading to impaired production of the -galactosidase enzyme. There are currently no approved treatments for GM1 gangliosidosis.

AXO-AAV-GM1 was granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) in November 2019.

About AXO-AAV-GM1

AXO-AAV-GM1 is an investigational gene therapy that delivers a functional copy of the GLB1 gene via an adeno-associated viral (AAV) vector, with the goal of restoring -galactosidase enzyme activity for the treatment of GM1 gangliosidosis. The gene therapy is delivered intravenously, which has the potential to broadly transduce the central nervous system and treat peripheral manifestations of the disease as well. Preclinical studies in murine and a naturally-occurring feline model of GM1 gangliosidosis have supported AXO-AAV-GM1’s ability to improve -galactosidase enzyme activity, reduce GM1 ganglioside accumulation, improve neuromuscular function, and extend survival.

About Axovant Gene Therapies

Axovant Gene Therapies is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease), and Parkinson’s disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit http://www.axovant.com.

In 2018, Axovant licensed exclusive worldwide rights from the University of Massachusetts Medical School (UMMS) for the development and commercialization of gene therapy programs for GM1 gangliosidosis and GM2 gangliosidosis, including Tay-Sachs and Sandhoff diseases. A three-way Cooperative Research and Development Agreement (CRADA) among Axovant, the NHGRI, and the University of Massachusetts was established in 2019 to support the conduct of the clinical program.

About the University of Massachusetts Medical School

The mission of the University of Massachusetts Medical School is to advance the health and well-being of the people of the commonwealth and the world through pioneering education, research, public service and health care delivery.

Research into potential therapies for lysosomal storage diseases such as Tay-Sachs, Sandhoff disease and GM1 gangliosidosis at UMass Medical School and Auburn University has led to significant advances in the field. Miguel Sena-Esteves, PhD, associate professor of neurology at UMass Medical School; Heather Gray-Edwards, PhD, DVM, formerly of Auburn and currently assistant professor of radiology at UMass Medical School; and Douglas Martin, PhD, professor of anatomy, physiology and pharmacology in the College of Veterinary Medicine and the Scott-Ritchey Research Center at Auburn University, have worked collaboratively for more than a decade on animal models and therapeutic approaches for these and similar disorders. For more information, visit http://www.umassmed.edu.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "anticipate," "will," "would," "should," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. For example, all statements Axovant makes regarding the initiation, timing, progress, and reporting of clinical data for its clinical programs, are forward-looking. All forward-looking statements are based on estimates and assumptions by Axovant’s management that, although Axovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Axovant expected. Such risks and uncertainties include, among others, the initiation and conduct of the AXO-AAV-GM1 program and the availability of data for disclosures; Axovant’s scientific approach and general development, manufacturing and regulatory progress; Axovant’s ability to perform under its existing clinical and business collaborations; and risks of unforeseen operational delays and other uncertainties caused by the COVID-19 pandemic. These statements are also subject to a number of material risks and uncertainties that are described in Axovant’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on February 10, 2020, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Axovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Media and Investor Contact: Parag Meswani Axovant Gene Therapies (212) 547-2523 investors@axovant.com media@axovant.com

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Axovant Completes Enrollment of Low-Dose Cohort in Phase 1/2 Study of AXO-AAV-GM1 and Expands Study to Include Type I (Infantile Onset) Patients with...

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Bioreactors Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Cell; Molecule; Technology; End User, and Geography" report has been added to ResearchAndMarkets.com's offering.

The bioreactors market was valued at US$ 2,958.50 million in 2019 and is projected to reach US$ 5,169.01 million by 2027; it is expected to grow at a CAGR of 7.3% from 2020 to 2027. The increasing adoption of single-use bioreactors, and rapid growth of the pharmaceuticals and biotechnology industries are among the prime factors driving the bioreactors market. However, stringent regulatory frameworks hinder the growth of the market.

The use of single-use bioreactors has increased in the modern biopharmaceutical processes in the last few years. This can be attributed to their unique ability to allow enhanced process flexibility, reduce investment requirements, and limit operational costs. Also, many companies have developed single-use bioreactors for the production of a wide range of therapeutics. For instance, Distek Inc., has developed a benchtop single-use bioreactor system for recombinant protein production. Single-use bioreactors reduce the risks of contamination and decrease production turnaround times. Moreover, the reduction in validation time has been one of the prime benefits of single-use bioreactors. The rising adoption of single-use bioreactors for upstream bioprocessing is driving the growth of the market.

The global bioreactors market is segmented on the basis of cell, molecule, technology, and end user. The bioreactors market, by molecule, is segmented into monoclonal antibodies, vaccines, recombinant proteins, stem cells, gene therapy, and others. The monoclonal antibodies segment held the largest share of the market in 2019. However, the stem cell segment is projected to register the highest CAGR in the market during the forecast period. Based on cell, the bioreactors market is segmented into mammalian cells, bacterial cells, yeast cells, and others. Based on technology, the market is segmented into wave-induced motion sub, stirred sub, single-use bubble column, and others. Based on end user, the market is segmented into research and development organizations, biopharma manufacturers, contract manufacturing organizations (CMOs).

Key report benefits:

Key Topics Covered:

1. Introduction

2. Bioreactors Market - Key Takeaways

3. Research Methodology

4. Global Bioreactors Market- Market Landscape

4.1 Overview

4.2 PEST Analysis

4.3 Expert Opinion

5. Global Bioreactors Market - Key Market Dynamics

5.1 Market Drivers

5.1.1 Increasing Adoption of Single-Use Bioreactors

5.1.2 Rapid Growth of Pharmaceutical and Biotechnology Industry

5.2 Market Restraints

5.2.1 Stringent Regulatory Framework

5.3 Market Opportunities

5.3.1 Rising Demand of Personalized Medicine

5.4 Future Trends

5.4.1 Technological Advancements in Bioreactors

5.5 Impact analysis

6. Bioreactors Market- Global Analysis

7. Bioreactors Market- By Cell

7.1 Overview

7.2 Bioreactors Market Share, by Cell, 2019 and 2027 (%)

7.3 Mammalian Cells

7.4 Bacterial Cells

7.5 Yeast Cells

7.6 Others

8. Bioreactors Market- By Molecule

8.1 Overview

8.2 Bioreactors Market Share, by Molecule, 2019 and 2027 (%)

8.3 Monoclonal Antibodies

8.4 Vaccines

8.5 Recombinant Proteins

8.6 Stem Cells

8.7 Gene Therapy

8.8 Others

9. Global Bioreactors Market Analysis- By Technology

9.1 Overview

9.2 Global Bioreactors Market, By Technology 2019 & 2027 (%)

9.3 Wave-Induced Motion SUB

9.4 Stirred SUB

9.5 Single-Use Bubble Column

9.6 Other Technologies

10. Global Bioreactors Market Analysis- By End User

10.1 Overview

10.2 Global Bioreactors Market, By End User 2019 & 2027 (%)

10.3 Research And Development Organizations

10.4 Biopharma Manufacturers

10.5 Contract Manufacturing Organisations (CMOs)

11. Bioreactors Market - Geographical Analysis

12. Bioreactors Market - Industry Landscape

12.1 Overview

12.2 Growth Strategies Done by the Companies in the Market, (%)

12.3 Organic Developments

12.3.1 Overview

12.4 Inorganic Developments

12.4.1 Overview

13. Company Profiles

14. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/235ppa

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Global Bioreactors Market Forecast to 2027 - COVID-19 Impact and Analysis by Cell, Molecule, Technology, End User and Geography -...

Recommendation and review posted by Bethany Smith

The latest report pertaining to The Future of Gene Therapy Market collated by Market Study Report, LLC, provides a detailed analysis regarding market size, revenue estimations and growth rate of the industry. In addition, the report illustrates the major obstacles and newest growth strategies adopted by leading manufacturers who are a part of the competitive landscape of this market.

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According to a new report, the global gene therapy market is anticipated to reach USD 4,300 million by 2021. The demand for gene therapy is primarily driven by continuous technological advancements and successful progression of several clinical trials targeting treatments with strong unmet need. Moreover, rising R&D spend on platform technologies by large and emerging biopharmaceutical companies and favorable regulatory environment will accelerate the clinical development and the commercial approval of gene therapies in the foreseeable future. Despite promise, the high cost of gene therapy represents a significant challenge for commercial adoption in the forecast period.

Gene therapy offers promise in the treatment of range of indications in cancer and genetic disorders. Large Pharmaceuticals and Biotechnology companies exhibit strong interest in this field and key among them include Allergan, Shire, Biomarin, Pfizer and GSK. The gene therapy space is witnessing a wave of partnerships and alliances. Pfizer has recently expanded its presence in gene therapy with the acquisition of Bamboo Therapeutics and Allergan entered the field, with the acquisition of RetroSense and its Phase I/II optogenetic program.

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North America holds a dominating position in the global gene therapy market which is followed by Europe and the Asia Pacific. The U.S. has maximum number of clinical trials ongoing followed by Europe. Moreover, the field of gene therapy in the U.S. and Europe continues to gain investor attention driven by success of high visible clinical programs and the potential of gene therapy to address strong unmet need with meaningful commercial opportunity. Moreover, the increasing partnerships and alliances and the disruptive potential of gene therapy bodes well for the sector through the forecast period.

Gene therapy involves inactivating a mutated gene that is not functioning properly and introducing a new gene to assist in fighting a disease. Overall, the field of gene therapy continues to mature and advance with many products in development and nearing commercialization. For instance, Spark Therapeutics received approval of Luxturna, a rare form inherited blindness in December 2017. Gene therapy market in late 2017 also witnessed the approvals of Gilead/Kite Pharmas Yescarta and Novartis Kymriah in the cancer therapeutic area.

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Key Findings from the study suggest products accessible in the market are much competitive and manufacturers are progressively concentrating on advancements to pick up an aggressive edge. Companies are in a stage of development of new items in order to guarantee simple implementation and connection with the current gene. The hospatility segment is anticipated to grow at a high growth rate over the forecast period with the expanding utilization of smart locks inferable from expanding security-related worries among clients amid their stay at the hotels. North America is presumed to dominate the global smart locks market over the forecast years and Asia Pacific region shows signs of high growth owing to the booming economies of India, and China.

The Future of Gene Therapy Market share byMajor regions included:

United StatesNorth AmericaAsia PacificEuropeMiddle East & Africa

Table of Contents

1.Gene Therapy Overview1.1.History and Evolution of Gene Therapies1.2.What is Gene Therapy1.3.Types of Gene Therapy1.4.Ex vivo and in vivo Approaches of Gene Therapy1.5.RNAi Therapeutics1.6.CAR-T Technology based Gene Therapy1.7.Types of Vectors used for Gene Therapy1.7.1.Viral1.7.2.Non-Viral2.Historical Marketed Gene Therapies [2003-2012]2.1.Rexin-G (Epeius Biotechnologies Corporation)2.2.Gendicine (SiBiono GeneTech Co., Ltd)2.3.Neovasculgen [Human Stem Cells Institute (HSCI))2.4.Glybera (UniQure Biopharma B.V.)3.First Countries to get an access to Gene Therapies3.1.Philippines for Rexin-G [2003]3.2.China for Gendicine [2003]3.3.Russia for Neovasculgen [2011]3.4.Selected European Countries for Glybera [2012]4.Marketed Gene Therapies [Approved in Recent Years]4.1.KYMRIAH (tisagenlecleucel)4.1.1.Therapy Description4.1.2.Therapy Profile4.1.2.1.Company4.1.2.2.Approval Date4.1.2.3.Mechanism of Action4.1.2.4.Researched Indication4.1.2.5.Vector Used4.1.2.6.Vector Type4.1.2.7.Technology4.1.2.8.Others Development Activities4.1.3.KYMRIAH Revenue Forecasted till 20214.2.YESCARTA (axicabtagene ciloleucel)4.2.1.Therapy Description4.2.2.Therapy Profile4.2.2.1.Company4.2.2.2.Approval Date4.2.2.3.Mechanism of Action

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Global and Regional The Future of Gene Therapy Market Research 2018 Report | Growth Forecast 2026 - Medic Insider

Recommendation and review posted by Bethany Smith

Medication abortion, also known as medical abortion or abortion with pills, is a pregnancy termination protocol that involves taking two different drugs, Mifepristone and Misoprostol, that can be safely used up to the first 70 days (10 weeks) of pregnancy. Since the U.S. Food and Drug Administration (FDA) first approved the drug in 2000, its use in the United States has quickly grown, with over a third of abortions at 8 weeks gestation or less being medication abortions. While this protocol involves taking two medications, and does not involve a medical procedure, it is subject to many of the same abortion specific provider restrictions as other abortion methods, at both the state and federal levels. This factsheet provides an overview of medication abortion, with a focus on federal and state regulations pertaining to its provision and coverage, and the role of the drug in self-managed abortions.

The most common medication abortion regimen in the United States involves the use of two different medications: mifepristone and misoprostol. Mifepristone, sold under the brand name Mifeprex and also known as the abortion pill, RU-486, blocks progesterone, a hormone essential to the development of a pregnancy, and thereby prevents an existing pregnancy from progressing. Misoprostol, taken 24-48 hours after mifepristone, works to empty the uterus by causing cramping and bleeding, similar to an early miscarriage. A follow-up visit is typically scheduled a week or two later, to confirm that the pregnancy was terminated via ultrasound or blood test. Medication abortion is a safe and highly effective method of pregnancy termination if the pills are administered at 9 weeks gestation or less, the pregnancy is terminated successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).

Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. The FDA first approved Mifeprex in 2000, and in 2016, the FDA approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy (Table 1).

Mifepristone cannot be dispensed by retail pharmacies like most other medications; rather pregnant patients can only obtain the drug directly from a certified medical provider who has filled out a prescriber agreement form from the manufacturer about the proper use of the drug. This is because the FDA has applied a Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex since 2011 (See Box 1).

If the FDA decides these measures are not sufficient to safely allow the drug on the market, the agency may require a more stringent version of REMS, including one or more Element to Assure Safe Use (ETASU). More than half of the currently approved REMS programs have one or more ETASU. FDA guidelines stipulate that an ETASU must be commensurate with the specific serious risk listed in the drugs labeling, and must not be unduly burdensome on access to the drug, especially for patients with serious or life-threatening diseases and who have difficulty accessing healthcare.

A variety of organizations, such as the American College of Obstetricians and Gynecologists (ACOG), support the elimination of REMS regulations for mifepristone, which they maintain are medically unnecessary and impede access to medical abortion. The former FDA commissioner, Jane Henney, and physician Helene D Gayle published a perspective arguing that the FDA should reevaluate the REMS regulations, in light of studies that show mifepristone as safe and effective. Some advocates suggest that the REMS process limits the pool of providers and consequently delay care for pregnancy patients, as they must search for certified providers. Finally, some providers are challenging the REMS designation for mifepristone in court.

The FDA guidelines and label for Mifeprex apply equally to the approved generic. The FDA-approved REMS program for Mifeprex, and now, the generic mifepristone, also includes Element to Assure Safe Use (ETASU), a stronger version of REMS, and contains three provisions:

On October 3, 2017, the American Civil Liberties Union (ACLU) filed a lawsuit, on behalf of a group of providers, against the FDA challenging the REMS requirements for mifepristone. These plaintiffs cite the low rate of complications associated with medical abortions and assert that other drugs with similar or more serious risks do not have REMS restrictions, and are unduly burdensome on patients trying to access the drug, particularly patients in rural or medically underserves areas. The District Court of Hawaii is waiting to take action on this case until the Supreme Court issues a decision in June Medical Services LLC v. Russo which involves both the third-party standing of providers to bring legal challenges on behalf of their patients, and the assessment of undue burden in abortion cases. In May 2020, the ACLU filed another lawsuit challenging the REMS requirement that mifepristone be dispensed in-person; this wasfiled on behalf of the American College of Obstetricians and Gynecologists (ACOG), in addition toother organizations.

Federal and state-level regulations have effectively limited the use of mifepristone, particularly in underserved areas without a nearby clinic. Studies show providers of medication abortion are mostly concentrated where surgical abortion is already available. Many state laws regulating abortion providers apply to all types of abortion procedures. For example, 17 states require the clinic to meet structural standards comparable to ambulatory surgical centers, such as maintaining standard operating rooms, surgical examination tables, and more. Seven states require that abortion providers have hospital admitting privileges or an alternative arrangement in place. Many states have also passed laws specifically pertaining to medication abortion, such as specific counseling and provider requirements. Currently, the 33 states permit only licensed physicians to dispense mifepristone pills (Figure 1). Research demonstrates that advanced practice clinicians (APCs), such as nurse practitioners, physician assistants, or nurse-midwives, can dispense provide abortion pills as safely as physicians can, but they are only permitted do to so in 17 states and DC.

Arkansas, Idaho, Kentucky, Nebraska, Oklahoma, South Dakota, and Utah have enacted laws that require providers to counsel patients that medication abortion may be reversed if given a high dose of progesterone after taking mifepristone despite a lack of scientific evidence to support this claim. Similar laws were passed in Arizona, North Dakota, and Kansas, with courts blocking the laws in Arizona and North Dakota, and the Governor vetoing the bill in Kansas.

Insurance coverage for abortion is heavily regulated at both the federal and state level. Since 1977, the federal Hyde Amendment has banned the use of any federal funds for abortion, unless the pregnancy is a result of rape, incest, or if it is determined to endanger the womans life. After the FDA approved Mifeprex in 2000, this law also applied to medication abortions. However, a 2019 study from the U.S. Government Accountability Office (GAO) found that 14 state Medicaid programs do not cover mifepristone even in the cases of rape, incest, and life endangerment as is required by the Hyde amendment.

States also regulate fully insured private insurance, including plans on the Affordable Care Act (ACA) Marketplaces. 11 states limit abortion coverage in private insurance plans some of these states follow the Hyde exceptions, while others are more restrictive. In 2020, 33 states had no ACA Marketplace plans that offered abortion coverage, with 26 states categorically banning it. Several plans that offered coverage for abortion procedures did not cover medication abortion, and some plans that did offer abortion coverage had differences in gestational limits, annual/lifetime caps on claims, and coverage of mifepristone. Conversely, six states (California, Illinois, Maine, New York, Oregon, and Washington) require all state-regulated private health plans (including Marketplace plans) to include abortion coverage. Self-insured plans are not regulated by state insurance law, and federal law does ban or require abortion coverage in self-insured plans. Although there has been no recent research on abortion coverage offered by fully insured plans in the remaining 33 states and the District of Columbia, Danco Laboratories offers a collection of state payer policies and how they relate to Mifeprex.

In 2014, the average amount paid for a medication abortion up to 10 weeks was $535, while the average amount paid for an abortion in a clinic and local anesthetic was $508. Although Danco Laboratories does not make the cost of Mifeprex public, providers report that Mifeprex costs them around $90 a pill. GenBioPro, the manufacturer of the generic mifepristone drug also does not report the cost of their pill, but has stated that they want to drive down costs for those who choose medication abortion.

For those who do not have abortion coverage, there are other a limited means of financial support, promoted on both Danco and GenBioPros website. The National Abortion Federation, as well as local abortion funds are sometimes able to cover some of the cost of an abortion (including travel) for a pregnant person. Outside of these funding sources or a sliding fee scale clinic, there are few options to help with abortion costs.

Although the overall rate of abortion has continued to decline, the use of medication abortion has greatly increased over the years, and now makes up roughly 41% of all abortions at 8 weeks gestation or less (Figure 2).

According to Danco Laboratories, by 2016, over 2.75 million women in the United States have used Mifeprex since its FDA approval in 2000. Data from the Centers for Disease Control and Prevention (CDC) shows that from 2007 to 2016, reported abortions at 8 weeks gestation or less increased by 2.5%, while reported abortions between 9-13 weeks decreased by 7.9%. A 2017 Guttmacher Institute Report found that medication abortion performed up to 9 weeks gestation accounted for 39% of all nonhospital abortions.

Telemedicine, or telehealth, can be used to expand access to health services in areas where the number of providers is limited. Many women, particularly those who live in rural communities, have to travel long distances to obtain abortion services, which has raised interest in the potential of telemedicine to expand access medication abortion. Because the newest FDA label allows women to take the pills after leaving the clinic, telemedicine has emerged as a viable option to expand the availability of abortion to women who are either unable to travel to clinic or for other reasons wish to have an abortion in the privacy of their own home.

As part of efforts to limit abortion access, many states have taken action to block the use of telemedicine for abortion. Six states, Arizona, Arkansas, Idaho, Missouri, Louisiana, and West Virginia, have passed laws specifically banning telemedicine for abortion provision. In addition, 15 other states have enacted laws that require the clinician providing a medication abortion to be physically present during the procedure, effectively prohibiting the use of telemedicine to dispense medication for abortion remotely (Figure 3).

Self-managed abortion, sometimes referenced as self-induced or at-home abortion, is when a person ends a pregnancy outside the medical care setting, typically by ordering abortion pills online. This practice is legal in the U.S., but is permitted in some other countries. Women may w may seek to manage their own abortion for many reasons, including clinic access barriers, cost, transportation, and privacy. The median cost of mifepristone-misoprostol products ordered online is approximately $205, about half of the average charge for a clinic abortion. Legal barriers, such as the threat of criminal charges, to self-managed abortion affect pregnant people as well as those who help them in ending their pregnancy.

Women Help Women, which already operates to provide pills to women in other countries, recently launched Self-managed Abortion; Safe and Supported (SASS), to provide information about self-managed medication abortion to women in the United States. However, due to legal barriers, they do not ship pills to women in the United States. A few projects, such as the Plan C Campaign, are now working to inform women in the US about self-managed abortions, including how to appropriately take the drugs, how they might access funds to pay for them, and a list of online retailers with reviews on price, ship time, product quality, and physician oversight. The FDA has issued warning letters to some of these organizations, including Aidaccess.org and RAblon, asking them to immediately cease the introduction of abortion medications into the U.S., as mifepristone may only be legally dispensed using the REMS protocol.

Even as overall rates of abortion decline, the use of medication abortion has grown significantly since its approval by the FDA in 2000. The drugs availability may have shifted the average time abortions occur to earlier in pregnancy. Its uptake, however, has been limited by federal and state regulations. Including the FDA REMS requirement, bans on telemedicine and requirements for in person dispensation of mifepristone, and requirements for in person counseling visits and other tests that are not medically recommended for safety. While some states continue to impose regulations that restrict access, others are exploring ways of increasing access by allowing non-physician clinical providers to prescribe mifepristone and testing the effectiveness of telemedicine to expand access to abortion services for those who seek them.

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The Availability and Use of Medication Abortion - Kaiser Family Foundation

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COVID-19 emerged just over six months ago and in this short span of time, researchers have found a lot about the disease. So far, it is known that men, the elderly and those with co-morbidities are at a higher risk of severe COVID-19.

Now, a group of researchers suggest that men with male pattern baldness (or androgenic alopecia) are more likely to develop severe COVID-19. The link has been proposed on the basis of two different studies on patients in Spain.

The researchers are calling this risk factor the Gabrins sign after Dr Frank Gabrin, the first US physician to die of COVID-19. Dr Gabrin had androgenic alopecia and he was also fighting bilateral testicular cancer.

The studies

For the first study, 41 COVID-19 patients with bilateral pneumonia were analysed. They were all Caucasian men. Out of them, 71 percent had clinically significant androgenic alopecia (AA) while the rest 29% had some signs of the AA. A total of 39% had severe AA.

For the second study, the researchers studied 175 COVID-19 patients. The male to female ratio was 2.3:1. Out of the group, about 79% of the men and 42% of the women had androgenic alopecia. However, most women were in the older age group as compared to men.

Representational image. Image by Ira Lee Nesbitt from Pixabay

Androgenic alopecia, androgens and SARS-CoV-2

Androgenic alopecia is the most common cause of hair loss in men. Though it also occurs in women, the pattern of hair loss differs in both genders. As per the US National Library of Medicine, in men, hair loss occurs at the temples and crown and leads to a receding hairline whereas in women, this hair loss is from all over the head and there is no receding of the hairline. Also, the condition may lead to complete baldness in men but not in women.

Though the exact cause of the condition is unknown, experts suggest that it occurs due to variations in the androgen receptor gene located on the X chromosome. Androgens are male hormones such as testosterone and dihydrotestosterone. These variations increase the activity of androgen receptors. It has been previously shown that an increase in the expression of the androgen receptor gene leads to higher activity of a protein that activates the spike protein of SARS-CoV-2 virus, which, in turn, helps it bind to the ACE-2 receptors.

More things to consider

In the first study, the authors mentioned that it was only based on visual diagnosis and no information was available on whether any of the people in the study already had got anti-androgen treatment as it would then change the finding of the study.

Regardless, it was suggested that that given the association, anti-androgen therapy may be beneficial for COVID-19 patients.

The study also pointed out that hydroxychloroquine (HCQ), the most debated drug for COVID-19, has shown some androgen (specifically, testosterone) reducing action in mice and a combination of HCQ and itraconazole is currently being studied for prostate cancer treatment. Androgens promote the growth of prostate cancer so those with the disease are given hormone therapy to reduce the production or use of androgens in the body.

For more information, read our article on Baldness.

Health articles in Firstpost are written by myUpchar.com, Indias first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

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People with male pattern baldness may be more susceptible to severe COVID-19, says study by Spanish... - Firstpost

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Most American women use some type of contraception in their lifetimes, according to the Centers for Disease Control and Prevention. Nearly 13% of women aged 15 to 49 are currently on the pill, while about 10% use an intrauterine device or contraceptive implant.

Those birth control options are often touted as safe and effective methods for preventing pregnancy or addressing hormonal imbalances.

But Dr. Jolene Brighten suggests that isnt the whole story. Dr. Brighten, a naturopathic physician and womens health specialist by training, explores the effects hormones can have on womens health.

Dr. Jolene Brighten teaches women about the effects of birth control.

Thats why she wrote the book Beyond the Pill: A 30-Day Program to Balance Your Hormones, Reclaim Your Body, and Reverse the Dangerous Side Effects of the Birth Control Pill, to delve deep into the issues that can arise with the use of the pill.

I wanted to provide women with a users manual for their bodies and give them the information I wish Id been given early in life, Dr. Brighten said.

If women are diagnosed with a hormonal issue, theyre often offered the pill as the first or sometimes only solution. But Dr. Brighten seeks to educate women about the effects hormone imbalances can have on their well-being. The book also offers advice to remedy these imbalances through lifestyle changes, supplements, and nutritional modifications.

Some women experience side effects when they start birth control, including hair loss, lagging libido, extreme fatigue, and chronic infection. And those issues arent always taken seriously by their doctors. But women may not realize that they dont have to live with those problems. Dr. Brighten discusses in her book how to locate the root cause of hormonal issues, attain a pain-free, manageable period free of cramps, acne, stress or PMS, and how to support liver detox, among other helpful topics.

The book also provides them with tools to have a more productive conversation with their doctors and monitor and support their health if they do choose hormonal birth control, Dr. Brighten said.

In addition to books, her website, http://www.drbrighten.com, has articles and resources to help women identify their symptoms and have more informed interactions with their doctors.

Dr. Brighten said she doesnt think women always have the right tools to understand their own bodies. Instead, she believes that women are often recommended birth control without clearly understanding its risks.

Birth control can lead to a variety of issues in women, including thyroid dysfunction, adrenal problems, loss of libido, menstrual irregularities, PMS, and anxiety.

Women dont always link these problems to birth control or hormones, however. Until they read Dr. Brightens writings or consult with her, many believe they have to live with these symptoms.

We serve women all over the world who are struggling and feeling dismissed by doctors about their concerns, Dr. Brighten said.

But Dr. Brighten said she doesnt think that birth control is inherently bad. Instead, she said she believes that women should have all the information about it when making choices about what to put in their bodies.

I advocate for informed consent and want to support women in making the best decisions for themselves and staying healthy regardless of what decision that is, Dr. Brighten said.

In addition to her two books, Dr. Brighten and her team are always adding new content to her website and social media channels. The information comes from a variety of people with different backgrounds, as several members of the team have masters or doctoral degrees in public health or nutrition science. Others have personally struggled with their hormones or have seen their loved ones face issues.

Our teams mission is to help women take back their health by putting the foundational medicine in their hands, helping them understand their bodies, and advocate for better care from their providers, Dr. Brighten said.

In addition to reaching a global audience with her writing, Dr. Brighten is also a clinician who works with clients.

In her clinical practice, she focuses on teaching women to make better choices that support their wellness. Often, that focus turns to diet and supplement changes to promote hormonal balance.

Dr. Brightens expertise on the connection between womens hormones and nutrition informs those recommendations. She also shares that nutritional healing advice on her website.

As both my family and myself leverage supplements, I wanted to have a line of the highest quality products I could trust to give to my family and take myself. One of our core values is to think about our customers like our family, Dr. Brighten said.

Dr. Brighten offers a line of nutritional and herbal supplements that promote hormone health.

With that goal in mind, Dr. Brighten and her team created a line of nutritional and herbal supplements designed to support hormonal health. She began creating a supplement line when pursuing her degree in nutrition. During her research, she discovered that supplement quality varied considerably from product to product. So she decided to develop a standard, wholesome line of supplements to boost womens health.

Women struggling with digestive problems can benefit from Dr. Brightens Gut Rebuild supplements. If they feel like Omega-3, vitamin B, or magnesium are lacking in their diet, they could take a supplement or two every day to boost their health. Dr. Brighten also offers products that support balance, the adrenal glands, and prenatal health.

Women can either take supplements for a limited time or subscribe to have them delivered to their home once a month.

We aim to provide exceptional products that help women take back their hormones and their health, Dr. Brighten said.

Dr. Brighten has helped many women understand their bodies over the years. And plenty of them have spoken about the impact her work has had on their lives.

One client said, If it wasnt for Dr. Brightens work I wouldnt have my son. After all doctors gave up on me, I made an appointment to see her for one last chance at getting pregnant. She is warm, funny, and incredibly knowledgeable.

Even with all of the praise, Dr. Brighten is not resting on her laurels. Shes working on her next book, based on the feedback shes received from the community about the support women need.

Furthermore, Dr. Brighten said she aims to expand her website to become even more of a go-to resource for womens health. As the so-called Google of Womens Health, the site offers a wealth of advice relevant to improving womens lives.

She also said she plans to continue her research on post-birth control syndrome (PBCS), a collection of symptoms that occur after women discontinue birth control. Her recent book was the first to include a conversation on the topic.

We provide medically accurate information regarding womens bodies, health, and options. My primary aim is to give women information, so they know what steps to take to reduce their risk of side effects and when they need to advocate for themselves with a doctor, Dr. Brighten said.

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Dr. Jolene Brighten Helps Women Understand the Effects of Birth Control on Their Bodies and Hormones - DatingNews

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PHILADELPHIA The pandemic is helping U.S. abortion-rights advocates achieve a long-standing goal: Make it easier for women to use pills to end pregnancies up to 10 weeks.

Federal and state regulations have restricted access to medication abortion ever since the Food and Drug Administration approved it two decades ago. Nonetheless, use of the two-drug regimen has grown steadily, accounting for at least 40% of all abortions, even as the national abortion rate has fallen to historic lows, data show.

Before the coronavirus made seeking medical care in person risky for both patients and providers, efforts were well underway to expand access to abortion pills through telemedicine and mail-order pharmacies. Now, those efforts are accelerating and multiplying because suddenly a divisive political issue is also a matter of public health.

For patients seeking abortion, urgent modifications of current protocols are needed to ensure that patients can continue to obtain this time-sensitive treatment while limiting transmission of infection, 11 prominent reproductive health experts wrote last month in the journal Contraception.

The group, led by obstetrician-gynecologist Elizabeth Raymond, proposed reducing in-person clinic visits by eliminating ultrasounds and other tests that research shows are unnecessary for a safe, effective pill-induced abortion.

Planned Parenthood Southeastern Pennsylvania, which adopted the test-less approach in mid-March, quickly saw a shift. Although the total number of medication and surgical abortions remained about 800 a month, the proportion that used pills increased from 55% before the pandemic to 65% now.

We wouldnt be offering it if it werent safe, said Dayle Steinberg, president and CEO of the Southeastern Pennsylvania affiliate. The pandemic is showing us that we have to be nimble and adapt.

WHEN PRECAUTIONS BECOME DANGERS

Some background: Medication abortion starts with a pill called mifepristone, which blocks a hormone vital to pregnancy. That is followed 24 to 48 hours later by at least two misoprostol pills, which induce contractions. (Misoprostol is also used to treat stomach ulcers.)

In 2000, when the FDA made the controversial decision to approve mifepristone, it imposed stringent safety requirements. The drug can be dispensed only by specially certified health-care providers and only in clinics, hospitals, and medical offices not pharmacies like most prescription drugs.

Medical societies and public health experts have called on the FDA to remove the restrictions. Physician Jane E. Henney, FDA commissioner when mifepristone was approved, added her voice last year. Last month, so did Democratic Sens. Elizabeth Warren and Patty Murray, urging a reevaluation in light of the growing coronavirus disease pandemic.

The FDA has not budged, even though its own review says medication abortion has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.

Advocates have not been deterred by the FDAs inflexibility.

Over the last year, Gynuity Health Projects a New York City-based nonprofit that Raymond joined in 2010 has expanded its FDA-approved study of medication abortion via telemedicine from five states to 13. It enables women to have video conferences with certified doctors, then get the pills mailed to them to take at home.

Still, Gynuitys TelAbortion has served fewer than 1,000 women over more than three years. Partly, thats because the FDA requires all study participants to have an initial in-person visit and an ultrasound to make sure they are no more than 10 weeks pregnant.

BENDING THE RULES

Studies have shown an ultrasound is unnecessary; only 1% of women do not accurately recall the date of their last menstrual period, and medication abortion still works for the vast majority of them. Other parts of the typical medication abortion protocol a pelvic exam, blood tests, and a return visit to confirm the termination are also unneeded, research shows.

Thats why Raymond and her 10 colleagues wrote the Contraception article, which laid out a protocol for evaluating, treating, and following up with patients in a way that would bend but not break the FDA rules.

Although FDA-imposed restrictions on mifepristone may require patients to present to the abortion facility to obtain the drug, this protocol would enable every other part of the medication abortion process to be implemented without any in-person encounter, they wrote.

Nothing like an epidemic to accelerate innovations, Raymond said in an interview.

Abortion foes denounce such innovations as endangering womens health. So far, 18 states have enacted various laws designed to ban the use of telemedicine in medication abortion. More recently, several states have tried to ban all abortions under pandemic emergency orders restricting elective medical procedures.

While the political divide is wider than ever, even abortion-rights activists dont agree on how much medical support women seeking medication abortion need or how best to provide it.

Numerous international websites ship abortion pills without prescription or any medical oversight to women who self-manage the termination in secret. Recognizing that the internet makes such uncounted abortions virtually unstoppable, public health researcher Elisa Wells cofounded Plan C, a website with a report card that rates such websites on product quality, price, and shipping time.

In early March, as the pandemic deepened, Plan C took another step toward helping women self-manage: It asked doctors across the country to register with one of the two FDA-approved manufacturers of mifepristone so they can obtain pills to mail to women in their homes.

FDA regulations say mifepristone must be dispensed in a facility, but Plan C maintains that dispensing is different than delivering.

Most doctors read the (FDA regulations) to say the pills cant be mailed, Wells said, adding that a handful of doctors have joined the new initiative. We disagree.

Aid Access, a mail-order abortion-pill service overseen by Dutch physician Rebecca Gomperts, has already been ordered to cease and desist by the FDA.

Gomperts set up Aid Access last year using the model of her first abortion-pill service, Women on Web, which serves women in countries were abortion is illegal. Basically, the pregnant woman consults online with the prescribing doctor, then gets a script to email to an Indian company that ships the pills. Instructions explain how to use the drugs, what to expect, and when to see a doctor if problems occur.

Although Gomperts didnt respond to a request for comment, she was recently quoted in the New York Times saying that the pandemic has fueled demand, with about 3,000 women requesting help from Aid Access since late March.

As for the FDA, Gomperts has a complaint against the agency pending in federal court. The FDA, she maintains, is trying to deny the constitutional right to abortion.

Dr. Gomperts has standing to assert the constitutional rights of her patients seeking medical abortions in the U.S., her legal brief says.

More here:
Coronavirus pandemic is fueling efforts to increase access to abortion pills - Greater Milwaukee Today

Recommendation and review posted by Bethany Smith

The cultivation of grapes in Europe, whose acreage represents 3% of the total cultivable acreage, accounts for up to 65% of the pesticides used by EU growers, given the high incidence of powdery mildew and mildew in the productions. However, this percentage could be drastically reduced if the EU opted for the most advanced plant reproduction technologies, such as CRISPR, which would make it possible to obtain grape varieties resistant to both fungi.

Thus, research has been carried out in this field for several years in order to improve European grape varieties. In the case of Italy, in 2015, ten genetically edited grape varieties were registered in the National Variety Catalog, and in 2018, the first field harvests were carried out. Although still in the pre-commercial phase, the results so far have been positive in terms of resistance to diseases.

The researchers hope that the regulatory uncertainty of CRISPR technologies will be resolved (they are subject to the same regulations as transgenics, despite not being the same). They also hope that both producers and consumers will learn about the potential of these techniques to tackle the agro-food and environmental challenges that humanity is facing.

Source: agronewscastillayleon.com

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Genetic editing of grapes by CRISPR could reduce the use of pesticides in Europe - FreshPlaza.com

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There is new hope for cat lovers who are allergic to their pets. Rather than desensitizing the human, researchers are working to eliminate the Feld1 protein, the primary allergen, from the cat, using CRISPR-Cas9 gene-editing technology.

"One of the benefits of CRISPR, compared to other methods of tackling this problem, is that you can permanently remove Feld1, compared with other techniques that only reduce the allergen," said Nicole Brackett, PhD, from Indoor Biotechnologies.

Previous attempts to remove the allergen have included feeding cats a specially formulated food that reduces Feld1 in the saliva, so less ends up on the dander when they lick themselves, as reported by Medscape Medical News.

"We hope to get to a point where we can offer an injection, or a series of injections, you would get at the vet, which would make the cat allergen-free," said Brackett, who presented the research in a poster at the European Academy of Allergy and Clinical Immunology 2020 Digital Congress.

When you're using this kind of technology, you are taking on a tremendous amount of responsibility.

About 10% of humans are allergic to cats, and we see the ones who are affected by their own cats, said Dean Mitchell, MD, an allergist and immunologist from Mitchell Medical Group in New York City.

"This research is interesting, but when you're using this kind of technology, you are taking on a tremendous amount of responsibility," he told Medscape Medical News.

"It's really an exciting technology, but I think it's scary, altering genes," he said. "You never know what you're going to change. Maybe we should use it to cure COVID first."

For their study, Brackett and her colleagues used discarded tissue samples from 50 spayed and neutered cats to collect genomic DNA from the Feld1 chains1 and 2.

The first goal was to see how similar genes were between cats, she explained. "We wanted to target a region in the gene that is well conserved something you would see in all cats not a random mutation."

The researchers were able to sequence a panel of 10 guide RNAs and use CRISPR Cas-9 to edit the genes. "We now have proof of principle in a cat cell line," Brackett told Medscape Medical News.

We still have a long way to go, but should have something we can test in a cat in a couple of years. But, she acknowledged, "we still don't know the role of the protein in the cat."

Feld1 expression differs from cat to cat, Brackett pointed out. "Some cats have an abundance and some have very little. The expression can vary, even within one cat."

Speculation on the function of Feld1 also varies. Because it's produced in the sebaceous gland, "it may serve as a way to coat, or protect, the skin. Or maybe it has something to do with chemical communication, maybe to communicate with other cats," she said. "But the fact that we see so much Feld1 variability with no obvious correlating behaviors makes us think it's not essential. One of the benefits of our study is we may figure that out."

Her lab is also looking at Feld1 expression in wild cats to determine its origin from an evolutionary standpoint. "We are curious to see how this allergen has evolved in different species of cats," she explained.

Cat allergies "rank number two in frequency and seriousness of allergies after food allergies, causing people to need to be on steroids or medications," Mitchell told Medscape Medical News. "Fifty percent of my immunotherapy practice is cat or dog allergy; it's a significant problem."

Young kids can't play at their friend's houses, relationships are affected, and families have to choose between their beloved cat and a healthy family member, he said.

Sublingual immunotherapy of Feld1 has been proven effective in clinical trials and is common in Europe, but "only about 100 allergists in the United States offer it," Mitchell said. "It's been a very underappreciated therapy, and I really don't know why; maybe because it's not patentable by a drug company."

Sublingual drops are not covered by insurance, and the therapy runs about $120 per month in the United States. "I've helped hundreds of patients with it," said Mitchell, and usually the therapy significantly improves patient quality of life.

The fact is, people make major life choices based on their cats, Mitchell explained.

One of his pollen-allergic patients who loved both her cat and her cat-allergic boyfriend told him that her boyfriend wouldn't sleep over. "Can you help him?" she asked.

"The first day I see him, he's wheezing and can't breathe." Mitchell recalled. He treated the boyfriend with sublingual Feld1 immunotherapy. "After 4 or 5 months, he could go over to her house using inhalers on weekends sometimes. A year later, they moved in together and got married. The cat even slept on the bed at the end.

Mitchell discharged the boyfriend after 3 years of treatment. He ran into him on a New York sidewalk a couple of years later and asked how he was doing. It turned out the couple had gotten divorced.

"That's too bad, I told him. But at least you don't have to deal with the cat anymore," Mitchell recalled.

"Oh no, I liked the cat too much, he stayed with me," his patient told him.

Mitchell laughed. "You just can't make this stuff up!"

Brackett works for Indoor Biotechnologies as a scientist. Mitchell has disclosed no relevant financial relationships.

European Academy of Allergy and Clinical Immunology (EAACI) 2020 Digital Congress

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More Than One Way to Fix Cat Allergy - Medscape

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Join us on Friday, June 19, to find out how massively parallel microbial strain engineering may lead to the development of novel therapeutics to combat the most difficult antibiotic-resistant pathogens

Massively parallel microbial strain engineering on a CRISPR-based benchtop platform has enabled the exploration of the genetic dependencies of antibiotic function in unprecedented scale and detail. The ability to design and deliver precisely determined edits throughout the entire E. coli genome has resulted in an unparalleled opportunity to query a diverse population of strain variants for their growth responses to antibiotics from multiple different functional classes.

Find out more in this expert webinar as Dr. Dan Held, Director of Synthetic Biology, Microbial Applications Development, Inscripta, outlines how the knowledge garnered through the use of this strain engineering technology has significant potential to lead to the development of novel therapeutics against our most difficult antibiotic-resistant pathogens.

Key learning objectives

Who should attend?

This webinar will run on Friday, June 19, 2020, at:

Register to watch the full webinar here>>

SelectScience runs 3-4 webinars a month across various scientific topics,discover more of our upcoming webinars>>

Original post:
Expert Insight: Discover the genetic dependencies of antibiotic function - SelectScience

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The market research on Global CRISPR-Based Therapeutics Market 2020 by Company, Regions, Type and Application, Forecast to 2025 presents an in-depth analysis of market statistics in terms of revenues, segment-wise data, region-wise data, and country-wise data. The report aims to identify the dynamics of the global CRISPR-Based Therapeutics market and provide recent updates and insights that affect various segments of the global market. The market report sorts the market dependent on the manufacturer, region, type, and application. The report estimates and validates the market size of the global CRISPR-Based Therapeutics market. The report also delivers a forecast, which focuses on the market opportunities for the next five years (2020-2025) for each region. The scope of the study segments the global market by product type, application, end-use, and the region is explained. This research report is expected to enable clients to assess strategies deployed by market leaders.

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Global CRISPR-Based Therapeutics Market 2020 Industry Analysis by Manufacturers, Type, Application, End-User and Forecast 2025 - Jewish Life News

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XconomyBoston

Hearing loss can stem from a variety of reasons, but in rare cases its caused by genetic defects. Akouos is developing a gene therapy to address these problems and its planning an IPO to finance the first tests of its approach in humans.

In paperwork filed with regulators late Friday, Boston-based Akouos set a preliminary $100 million goal for its IPO.

The first target for Akouos is hearing loss due to mutations in the OTOF gene, which encodes a protein called otoferlin. Hearing happens when tiny hair cells in the inner ear pick up vibrations and turn them into signals that the brain interprets as sound. Otoferlin is key to this process, as it enables the sensory cells of the ear to release tiny membranes carrying neurotransmitters, Akouos says in its filing. These neurotransmitters activate auditory neurons, which in turn relay the information to the brain where it is recognized as sound.

Those who have OTOF gene mutations are typically born deaf. There are currently no FDA-approved therapies for this form of hearing loss. The experimental Akouos gene therapy, AK-OTOF, is intended to deliver a functioning version of the OTOF gene with the goal of restoring proper otoferlin expression.

The Akouos therapy is delivered using an engineered version of adeno-associated virus (AAV), an approach used by some FDA-approved gene therapies marketed by other companies for other diseases, as well as for some gene therapies still in development. But the anatomy of the inner ear presents challenges for AAV gene therapy delivery, the company says in its filing. Also, AAV has a limited capacity for carrying a genetic payload.

To overcome those limitations, Akouos uses synthetic AAVs that recreate naturally occurring viruses called ancestral AAVs, which the company says can reach the target in the ear. Furthermore, the company uses a dual vector approach that employs two engineered viruses, each carrying a fragment of the OTOF gene. The Akouos approach to gene therapy is based on the research of Luk Vandenberge, director of the Grousbeck Gene Therapy Center in Boston and a professor at Harvard Medical School. In mouse studies, Akouos says AK-OTOF delivered its genetic payload to the inner ear hair cells, restoring auditory function. Now the company wants to test its technology in humans.

Paperwork seeking FDA permission to start a clinical trial is on track to be submitted in 2021, Akouos says in its filing. If all goes as planned, the company expects to report preliminary data from the clinical trial the following year.

Akouos isnt the only company developing new treatments for inherited forms of hearing loss.Decibel Therapeutics is also developing a gene therapy to address the same genetic protein deficiency that Akouos is targeting. The Boston-based companys experimental gene therapy, DB-OTO, is in preclinical development with partner Regeneron Pharmaceuticals (NASDAQ: REGN). Otonomy (NASDAQ: OTIC), in San Diego, is advancing a preclinical gene therapy program intended to address hearing loss caused by mutations in another key gene, GJB2. Frequency Therapeutics (NASDAQ: FREQ) is addressing hearing loss caused by the loss of hair cells in the inner ear. The Woburn, MA-based company is developing a regenerative medicine approach that coaxes the regrowth of these hairs.

Akouos was founded in 2016 and unveiled $50 million in financing two years later. In March, the company closed a $105 million Series B round of financing that added crossover investors. The biggest shareholders in Akouos prior to the IPO are 5AM Ventures and New Enterprise Associates, which own about 21.6 and 18.5 percent respectively, according to the filing.

Akouos has applied for a listing on the Nasdaq under the stock symbol AKUS. If the company successfully completes the IPO, it says it will apply the capital toward clinical development of AK-OTOF, as well as the preclinical development of other programs in its pipeline.

Image: iStock/iLexx

Frank Vinluan is an Xconomy editor based in Research Triangle Park. You can reach him at fvinluan@xconomy.com.

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Akouos Aims for an IPO to Advance Hearing Loss Gene Therapy to Clinic - Xconomy

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Knowing what cancer will do next could lessen the likelihood of it becoming resistant to treatment. A new U of T study investigates how cancer adapts its metabolism to potentially overcome therapies still in development.

Several clinical trials have failed because metabolism is such an adaptive process by which cancer cells gain drug resistance, saysMichael Aregger, a co-lead author and Research Associate working withJason Moffat, Professor of molecular genetics in the Donnelly Centre for Cellular and Biomolecular Research, who co-led the work. If you know how cells are able to adapt to perturbations, maybe we can target them more specifically to avoid resistance from developing.

The research was also led byBrenda AndrewsandCharles Boone, University Professor and Professor of molecular genetics at the Donnelly Centre, respectively, andChad Myers, a Professor of computer science at the University of Minnesota-Twin Cities.

Thestudy, published this week in the journalNature Metabolism, is the first to investigate global changes in cancerous cells as they adapt to a shortfall of critical nutrients such as fat molecules, or lipids, which make up the cells outer envelope.

When cancer cells are unable to make their own lipids, they gobble them up from their environment to ensure a steady supply of these essential building blocks, the study found. Lipids also serve as fuel and chemical signals for communication between cells, among other roles.

"If you know how cells are able to adapt to perturbations, maybe we can target them more specifically to avoid resistance from developing" - Michael Aregger, Research Associate

The switch in metabolism could be bad news for drugmakers seeking to target cancer by reducing its lipid reserves. In particular, drugs that inhibit an enzyme called FASN, forfattyacidsynthase, involved in an early step of lipid synthesis, are being explored in patient trials. Fatty acids are precursors of larger lipid molecules and their production is increased in many cancers thanks to elevated FASN levels, which are also associated with poor patient prognosis.

The U of T study suggests that the effectiveness of FASN inhibitors could be short-lived owing to cancers ability to find another way to procure lipids.

Because FASN is upregulated in many cancers, fatty acid synthesis is one of the most promising metabolic pathways to target saysKeith Lawson, a co-lead author and PhD student in Moffats lab enrolled in the Surgeon-Scientist Program at the Faculty of Medicine. Given that we know there is a lot of plasticity in metabolic processes, we wanted to identify and predict ways in which cancer cells can potentially overcome the inhibition of lipid synthesis.

To block fatty acid synthesis, the researchers employed a human cell line from which the FASN coding gene was removed. Using the genome editing tool CRISPR, they deleted from these cells all ~18,000 or so human genes, one by one, to find those that can compensate for the halt in lipid production. Such functional relationships are also referred to as genetic interactions.

Data analysis, performed byMaximilian Billmann, a co-lead author and a postdoctoral fellow in Myers lab at Minnesota-Twin Cities, revealed hundreds of genes that become essential when cells are starved of fat. Their protein products clustered into well-known metabolic pathways through which cells hoover up dietary cholesterol and other lipids from their surroundings.

Cells intake of cholesterol has become textbook knowledge since it was discovered half a century ago, winning aNobel Prizeand inspiring the blockbuster drug statin and many others. But the new study found that one component of this process remained overlooked all this time.

The gene encoding it was only known as C12orf49, named after its location on chromosome 12. The researchers re-named the gene LUR1, forlipiduptakeregulator 1, and showed that it helps switch on a set of genes directly involved in lipid import.

This was a big surprise to us that we were able to identify a new component of the process we thought we knew everything about, says Aregger. It really highlights the power of our global genetic interaction approach that allowed us to identify a new player in lipid uptake in a completely unbiased way.

By a remarkable coincidence, two groups working independently in New York and Amsterdam also linked C12orf49 to lipid metabolism, lending further support for the genes role in this process. The New York team published their findings in the same journal issue as Moffat and colleagues.

Inhibiting LUR1, or other components of lipid import, along with FASN could lead to more effective cancer treatments. Such combination therapies are thought to be less susceptible to emerging drug resistance because the cells would have to simultaneously overcome two obstaclesblocked lipid production and importwhich has a lower probability of occurring.

Therapeutic context that comes out of our work is that you should be targeting lipid uptake in addition to targeting lipid synthesis and our work highlights some specific genes that could be candidates, says Lawson.

The research was supported by the Canadian Institutes for Health Research, Ontario Research Fund, Canada Research Chairs Program and the U.S. National Institutes of Health.

Reference:Aregger, M., Lawson, K.A., Billmann, M. et al. (2020) Systematic mapping of genetic interactions for de novo fatty acid synthesis identifies C12orf49 as a regulator of lipid metabolism. Nat Metab. DOI: https://doi.org/10.1038/s42255-020-0211-z

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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When Cancer Cells Cant Produce Their Own Fat, They Import More of It - Technology Networks

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CSL Behring, based in King of Prussia, Pennsylvania, is acquiring Vancouver, British Columbia-based Vitaeris. The two companies inked a strategic partnership in 2017 to accelerate the development of Vitaeriss clazakizumab. At that time, CLS Behring also had an option to acquire Vitaeris, the therapeutic, and the rest of Vitaeriss assets.

No financial details were disclosed. In the 2017 deal, Vitaeris retained control of projects through the end of Phase III development. There was an upfront cash payment of $15 million, with research-and-development milestone payments over that period, which included future sales-related payments, as well as a royalty to Alder BioPharmaceuticals, who originated clazakizumab.

Clazakizumab is an anti-interleukin-6 (IL-6) monoclonal antibody for the treatment of chronic active antibody-mediated rejection (AMR), which is the top cause of long-term rejection in kidney transplant patients. There are currently no treatments approved for transplant recipients who develop antibody-mediated rejection.

Clazakizumab will join CLS842 and CSL964 as part of CSL Behrings late-stage program related to transplants.

Clazakizumab has been a promising monoclonal antibody in the Transplant therapeutic area since we started working with Vitaeris several years ago, said Bill Mezzanotte, executive vice president, Head of R&D, CSL Behring. Acquiring Vitaeris and their associate expertise helps us to continue to grow our strategic scientific platform of recombinant proteins and antibodies. We look forward to continuing to advance this treatment candidate as a potential option for people experiencing rejectionan area where current treatment options for transplant recipients are limited, at best.

Also today, CSL Behring announced results from a Phase II clinical trial of garadacimab (formerly CSL312), an investigational novel Factor XIIa-inhibitory monoclonal antibody to prevent hereditary angioedema (HAE). The company presented results at the European Academy of Allergy and Immunology (EAACI) Digital Congress 2020.

The trial met the primary endpoint, showing a decreased number of attacks compared to placebo in patients with HAE. HAE is a rare, genetic and potentially life-threatening disease. HAE is one of two types of bradykinin-mediated angioedema, with the other being nonhereditary or acquired angioedema. HAE is the result of deficient or dysfunctional C1-INH, a blood protein that helps control inflammation.

Last month, the U.S. Food and Drug Administration (FDA) granted garadacimab orphan drug designation for bradykinin-mediated angioedema.

The attacks that HAE patients experience can be very frightening, and clinicians want to do anything in their power to reduce the frequency of these attacks, lessen the need for rescue medicine and simplify treatment, said Timothy Craig, lead study investigator with Allergy, Asthma and Immunology, Department of Medicine and Pediatrics, Penn State Hershey, Hershey, Pennsylvania. The findings of this study are very encouraging and we look forward to further research assessing the safety and efficacy of garadacimab.

CSL Behring has been quite busy recently. On June 2 the company announced a strategic alliance with Seattle Childrens Research Institute to develop stem cell gene therapies for primary immunodeficiency diseases. The initial focus will be on Wiskott-Aldrich Syndrome and X-linked Agammaglobulinemia.

The company is also working on several fronts to develop treatments and preventions for COVID-19. The company is part of the CoVIg-19 Plasma Alliance, which is working to develop an unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin therapy. The Alliance is also working with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) to test the hyperimmune therapy in adult patients with COVID-19. CSL Behring Australia is developing an anti-SARS-COV-2 plasma product for the Australian market. CSL Behring is also partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) and The University of Queensland (UQ) to speed the development, manufacture and distribution of a COVID-19 vaccine, as well as other initiatives in this space.

And on May 27, 2020, CSL Limited entered into a strategic partnership with Thermo Fisher Scientific to meet the growing demand for biologic therapies while also accelerating CSLs broader manufacturing objectives. Thermo Fisher will leverage its pharma services network to support CSLs product portfolio, and via a long-term lease deal, will operate a new state-of-the-art biologics manufacturing facility in Lengnau, Switzerland, which is being built now and is expected to be completed in mid-2021.

Of the acquisition by CSL Behring, Kevin Chow, president and chief executive officer of Vitaeris, stated, Were pleased to become part of CSL Behring, a well-established, global industry leader, and know that the future of clazakizumab is in excellent hands. Together, we have already achieved much progress through our partnership over the past few years and are now in an even stronger position to realize our collective goal of addressing one of the greatest unmet needs in the organ transplant community.

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CSL Behring Buys Vitaeris, Picks Up Transplant Rejection Therapeutic - BioSpace

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By Charles PillerJun. 8, 2020 , 7:00 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center.

Three unlikely collaborators are at the heart of the fast-moving COVID-19 research scandal, which led to retractions last week by The Lancet and The New England Journal of Medicine (NEJM), and the withdrawal of an online preprint, after the trove of patient data they all relied on was challenged. The three physician-scientists never were at the same institution nor had they ever before written together, but they are the only authors in common on the disputed papers, and the other co-authors all have ties to at least one of them. Their partnership, which seized a high-impact role during a global public health crisis, has now ended disastrously.

The first author for both retracted papers was cardiac surgeon Mandeep Mehra, an eminent Harvard University professor who works at Brigham and Womens Hospital (BWH) and is known internationally for cardiovascular medicine and heart transplants. He provided the kind of gravitas that can fast-track papers to leading journals. In a statement provided by BWH, Mehra said he had met another of the trio, cardiac surgeon Amit Patel, in academic and medical circles, and that Patel had introduced him to Sapan Desai, a vascular surgeon and founder of Surgisphere, the tiny company that supplied the data. Journal disclosures, however, also indicate Mehra received compensation from Triple-Gene, a gene therapy company Patel co-founded to develop cardiovascular treatments.

Desai publicly aspired to combine big data and artificial intelligence (AI) in ways that he said can replace randomized controlled clinical trials. For a brief moment, it seemed that Surgispheres enticing data set, said to include nearly 100,000 detailed patient records from about 700 hospitals on six continents, would settle questions about the possible benefits of various drugsincluding the controversial antimalarial hydroxychloroquinefor COVID-19 patients.

Patel once apparently headed cardiac surgery at the University of Miami Miller School of Medicine. A university press release announcing his arrival in 2016 is no longer posted on the university website, however, and the school has not confirmed his job duties there. More recently, he has been a volunteer adjunct professor at the University of Utah. But, as STAT first reported yesterday, Patel tweeted on Friday that he had severed his relationship with the university, which a school spokesperson confirmed. In recent years Patel has developed and commercialized experimental stem cell therapies purported to cure heart problems, reverse aging, or treat sexual dysfunction. He is also part of a network of physicians that just launched a trial to use stem cells from umbilical cord blood to treat COVID-19 patients.

Normally co-authors of high-profile papers share subject area expertise or have clear professional ties, says Jerome Kassirer, chief editor ofNEJMduring the 1990s. He calls the collaboration of the apparently disparate individuals completely bizarre, and a red flag that the studies warranted intensive scrutiny that the journals failed to provide.

None of the three co-authors responded to requests for comment. Patel spoke with aSciencereporter initially but said he wanted to wait for audits of the Surgisphere data to comment, and Desais spokesperson stopped communicating after the retractions. Still, interviews with former colleagues and a long paper trail shed some light on each of them.

Desai had a history of convincing respected researchers of his skill and integrity. One of them, Gilbert Upchurch, department of surgery chair at the University of Florida, wrote last year in a journal commentary that he had never met Desai but had nonetheless mentored him remotely and developed an online friendship with him. Upchurch placed the scientist in a group of amazing and talented young vascular surgeons.

Illinois court records show Desai is facing two medical malpractice lawsuits filed last year. He told The Scientist that he deems any lawsuit naming him to be unfounded.

Desai has a history of big aspirations and entrepreneurial venturessome short-lived. His science-fiction blog, corewardfront.com, was meant to find the most parsimonious route for mankind to establish a meaningful presence in space. In 2009, he wrote that the site would publish fiction grounded in facts and reality, adding, the scientific method must be followed religiously. The blog is no longer published.

As a student, Desai won several small National Institutes of Health (NIH) grants for studies of the vestibular system. He started Surgisphere in 2007, when he was a medical resident at Duke University. Surgispheres initial products were medical guides and textbooks, although Desai has said he was working on big data projects for the company from its birth. In 2010, under the firms auspices, he founded the Journal of Surgical Radiologywhose editors included researchers with well-established publishing records. It folded in January 2013. Articles from the journal were cited only 29 times in its history, according to Scimago, a journal rating service. Yet an undated Surgisphere web page, no longer accessible online, said the online-only publication had 50,000 subscribers and nearly 1 million page views monthlywhich would have placed it in elite company in academic publishing.

Surgisphere appears over time to have shifted its efforts into developing a database of hospital records that could be used for research. When the pandemic erupted, Desai declared that his data set could answer key questions about the efficacy and safety of treatments. Speaking about the finding that hydroxychloroquine increases mortality in COVID-19 patients, the main finding from the now retracted Lancet paper, he told a Turkish TV reporter, with data like this, do we even need a randomized controlled trial? Soon after, the World Health Organization temporarily suspended enrolling patients for its COVID-19 trial of the drug.

Immediately after the Lancet and NEJM studies appeared, however, critics identified anomalies in the data. And they doubted that a tiny firmwith a scant public track record in AI, few employees, and no publicly named scientific boardcould convince hundreds of unidentified hospitals in dozens of nations to share complex, protected, and legally fraught patient data. Ultimately, despite Desai promising repeatedly to allow an independent audit of Surgisphere, the firm refused to release the raw patient data and agreements with hospitals for an audit, so no one could validate the authenticity of its database.

No hospitals have come forward to acknowledge working with Surgisphere. Indeed, NHS Scotland, which is mentioned as a case study on the companys website, says none of its hospitals worked with Surgisphere and that it would ask the firm to remove an image of a Glasgow hospital from its website.

Science contacted several of Desais current or former employees or colleagues. Most would not comment. But Fred Rahimi, an Illinois podiatrist and co-author of a paper with Desai, praises the surgeon as highly capable for salvaging limbs, and easy to work with. Through his publicist, Desai cited Mark Melin, a University of Minnesota, Twin Cities, vascular surgeon, as a supporter. Before the retractions, Melin called Desai a gentleman of the highest integrity who has nothing to cover up.

But one physician-scientist who worked closely with Desai several years ago, says, Just about everyone who knew him would say: I just didnt have a good feeling about him. After theyd been with him, most people dissociated themselves from him, the scientist says, declining to be named to avoid personal and institutional embarrassment.

In the decade since completing his medical residency, Desai moved from job to jobat Duke, the University of Texas, Southern Illinois University, and two private Illinois hospitals, according to his LinkedIn profile. You might say we should have stopped him, which now seems obvious, Desais former colleague says. We should have found a way to get together and say, Whats going on here? rather than allowing him to move from place to place. We should have done better as a medical community. We looked the other way.

Before and after his stint at the University of Miami, which appears to have started in late 2016 or early 2017, Patels academic home was the University of Utah. He started as a full-time faculty member at Utah in 2008 and kept that position until he left for Miami. The website for Foldax, a heart valve company that he serves as medical adviser, describes him as a Tenured Professor of Surgery in the Division of Cardiothoracic Surgery at the University of Utah School of Medicine and Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah.

The university confirmed Patel had tenure there, but says the directorship was an unofficial title. And among more than 100 publications listed on his University of Utah profile, nearly two-thirds were actually co-authored by other scientists who share the same surname. The page was removed from the university website after inquiries from Science.

According to the NIH database, Patel has never received funding from the agency. Before the recent COVID-19 papers, one of his most notable publications was a 2016 paper in The Lancet, which reported that extracting stem cells from the bone marrow of a person with end-stage heart failure and then reinjecting them could reduce the number of cardiac events that produced deaths or hospital admissions by 37%. The 126 patient, 31-site, phase II trial was billed in a press release, now not available on the University of Utah website but stored elsewhere, as the largest cell therapy trial for heart failure to date. Despite the apparent positive results, the sponsoring company Vericel no longer is developing stem cells for heart disease and, according to its webpage, is focused on advanced cell therapies for the sports medicine and severe burn care markets.

Patel left Miami under unclear circumstances, but has retained ties with Camillo Ricordi, an influential stem cell researcher at the University of Miami School of Medicine who is also the founder of a nonprofit called the Cure Alliance. The alliance previously focused on testing whether stem cells derived from umbilical cord blood could treat diabetes or Alzheimers, but has now pivoted to fighting COVID-19, according to its website. Ricordi is the principal investigator on a multisite trial to see whether the stem cells can treat lung inflammation in severe COVID-19 patients and Patel is listed in various references to the trial as a key contributor or coprincipal investigator. Ricordi did not reply to requests for comments on his relationship with Patel.

Patel recently tweeted that he is related to Dr. Desai by marriage but called that old news and added, Despite this I still do not have the information of what happened at Surgisphere. In addition to apparently connecting Mehra and Desai, Patel had prior connections with other authors of the NEJM paper and the preprint. David Grainger, co-author of the preprint, is a professor of biomedical engineering at the University of Utah and also works with Foldax. Grainger declined to comment.

Timothy Henry, a cardiovascular clinician and scientist at the Christ Hospital in Cincinnati and a co-author on the NEJM article, has written several scholarly articles with Patel, including the 2016 Lancet paper. Henry, who also declined to comment, advises Patels Triple-Gene, which develops cardiovascular gene therapy treatments. Henry and Patel adviseand Patel is a board member ofCreative Medical Technology Holdings, a Phoenix company that develops and markets stem cell therapies, including treatments purported to reverse aging and cure sexual disfunction.

Creative Medicals CaverStem and FemCelz kits are distributed to physicians who use them to extract stem cells from a patients bone marrow, then inject the cells into the penis or clitoral area to stimulate blood flow, according to a statement filed with the U.S. Securities and Exchange Commission. (As of the market close Friday, the publicly traded firms shares were valued at one-third of 1 cent.) The CaverStem treatments are advertised by the company as successful in more than 80% of patients, based on a 40-person phase I clinical trial that was not randomized or controlled, and on observations of 100 other patients. Phase I trials typically measure safety, not health benefits of a potential treatment.

Science contacted multiple colleagues or co-authors of Patel. None would comment. Before the retractions, two high-profile researchersDeepak Bhatt, who directs interventional cardiovascular programs at BWH; and Peter Gruber, a pediatric cardiothoracic surgeon at Yale Universityendorsed Patel on his LinkedIn page. Bhatt says he doesnt know Patel and attempted to remove his endorsement after being contacted by Science. Gruber says he overlapped with Patel at the University of Utah about a decade ago, but doesnt know his work in detail.

In contrast, Mehraauthor of more than 200 scholarly articles, editor of The Journal of Heart and Lung Transplantation, and head of the cardiology division of theUniversity of Maryland before moving to BWH in 2012enjoys considerable support even after the unraveling of the recent studies. Obviously, you dont rise to the position hes risen to without being ambitious, but Ive never had any indication whatsoever that he would do anything unethical, says Keith Aaronson, a cardiologist at the University of Michigan, Ann Arbor, who collaborated with Mehra on several studies, including a clinical trial of a mechanical pump for heart failure patients.

Mehra, the first author on both retracted papers, was the only one to issue a personal statement of apology, for failing to ensure that the data source was appropriate for this use. BWH and Harvard declined to say whether further investigation of Mehras roles in the papers would occur. (Mehra has written papers recently with another co-author of the Lancet paper, Frank Ruschitzka of University Hospital Zrich.)

I think he just fell into thisperhaps a little navely, says another former collaborator, cardiothoracic surgeon Daniel Goldstein of the Albert Einstein College of Medicine. Given the amount of data that was in the [Surgisphere] database, its just hard to believe someone would [fabricate] something like this.

Kassirer offers a harsher view: If youre a scientist and youre going to sign on to a project, by God you should know what the data are.

With reporting by Kelly Servick and John Travis.

This story was supported by theScienceFundforInvestigativeReporting.

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Who's to blame? These three scientists are at the heart of the Surgisphere COVID-19 scandal - Science Magazine

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