Javier Saade serves on several boards, is venture partner at Fenway Summer and is a senior advisor at FS Vector, Fenway Summers advisory affiliate. Previously, he was associate administrator and chief of investment and innovation at SBA.

The last two decades have ushered in significant change and transformation. I believe the 2020s will be dispositive in redefining the pillars of our economy, and COVID-19 magnifies this greatly. As of this writing there are 3,611,394 confirmed cases, and the U.S. accounts for 33% of those. We are now dealing with a 4.8% Q1 GDP contraction and expectations for Q2s shrinking runs into the 25% range, more than 30 million unemployed and a $7 trillion federal intervention in a span of six weeks.

Eric Schmidt recently predicted that the coronavirus pandemic is strengthening big tech. It is hard to disagree with him; it almost feels obvious. Big tech and other digital companies are net beneficiaries of new habits and behaviors. Some of this shift will be permanent, and well-capitalized tech companies are likely to expand their power by grabbing talent and buying companies for their IP then dissolving them.

With power comes political backlash and public wariness. One flavor of that counter pressure is already in full effect. Sen. Elizabeth Warren and Rep. Alexandria Ocasio-Cortez have proposed new legislation that seeks to curtail acquisition activity via the Pandemic Anti-Monopoly Act. Ill reserve judgment on their effort, but the theme is familiar: the strong get stronger and the weak get weaker, which further widens gaps and calcifies disparity.

The COVID-19 shock is highlighting a chasm that has evolved over decades. The digital divide, lack of capital access, sporadic paths to education and microscopic levels of wealth accumulation in communities of color and the implicit/explicit bias against non-coastal elites are some contributing factors.

During the 2008 crisis, the combined value of the five biggest companies ExxonMobil, General Electric, Microsoft, AT&T and Procter & Gamble was $1.6 trillion. Microsoft is worth almost that today all by itself. No need to talk about FAANG, because since the pandemics economic halt, Peloton downloads went up five-fold in a month, Zoom grew to 200 million users from 10 million in December and Instacart users grew six times in that period.

Roelof Botha of Sequoia Capital was recently quoted as saying, Like the killing off of the dinosaurs, this reorders who gets to survive in the new era. It is the shock that accelerates the future that Silicon Valley has been building. It is hard to argue with his views.

To be clear, I am a beneficiary of and a big believer in technology. Throughout my career I have managed it, invested in it and made policy on it. For example, one of the multi-billion-dollar programs I oversaw, the Small Business Innovation Research (SBIR) program, has invested more than $50 billion in tens of thousands of startups, which have collectively issued 70,000 patents and raised hundreds of billions of capital and 700 of them have gone public, including tech titans such as Qualcomm, Biogen and Symantec.

My point: I think about technology a lot, and, lately, about its repercussions. There is a massive shift afoot where more power and influence will be consolidated by these remarkable companies and their technology. Besides the economic consequences of the strong crushing the weak, there are serious ethical issues to consider as a society. Chamath Palihapitiya has been pretty vocal about the moral hazard of what is essentially a massive transfer of wealth and income. On one side you have mismanaged and/or myopic corporations and on the other, the counterparty is the American people and the money we need to print to bankroll the lifeline. I am not talking about Main Street here, by the way.

It is not hard to imagine a world in which tech alone reigns supreme. The ethical dilemmas of this are vast. A recent documentary, Do You Trust this Computer, put a spotlight on a frantic Elon Musk ringing the alarm bell on machines potential to destroy humanity. Stephen Hawking argued that while artificial intelligence could provide society with outsized benefits, it also has the potential to spiral out of control and end the human race. Bill Gates has been less fatalistic, but is also in the camp of those concerned with synthetic intelligence. In an interesting parallel, Bill has for years been very vocal on the risks pandemics pose and our lack of preparedness for them indeed.

These three men have had a big impact on the world with and because of technology. Their deep concern is rooted in the fact that once the genie is out of the bottle, it will make and grant wishes to itself without regard to humanity. But, is this doomsday thinking? I dont know. What I do know is that I am not alone thinking about this. With COVID-19 as a backdrop, many people are.

Algorithmic sophistication and computer horsepower continue to evolve by leaps and bounds, and serious capital continues to be invested on these fronts. The number of transistors per chip has increased from thousands in the 1950s to over four billion today. A one-atom transistor is the physical boundary of Moores Law. Increasing the amount of information conveyed per unit, say with quantum computing, is the most realistic possibility of extending Moores Law, and with it the march toward intelligent machines and a tech first world. The march has been accelerated, even if peripherally, by the pandemic.

While the promise of technology-driven progress is massive, there are some serious societal costs to exponential discovery and unleashed capability acceleration. Dartmouths Dr. James Moor, a notable thinker at the intersection of ethics and technology, believes that the use and development of technologies are most important when technologies have transformative effects on societies. He stipulates that as the impact of technology grows, the volume and complexity of ethical issues surrounding it increases. This is not only because more people are touched by these innovations, they are. It is because transformative technology increases pathways of action that outstrip governance systems and ethical constructs to tame it.

So what? The twists and turns of technology application lead to consequences, sometimes unknowable and for that reason we should be increasingly vigilant. Did Zuckerberg ever imagine that his invention would have been so central to the outcome of the 2016 election? Unknowable consequences, exhibit one. Interconnected systems touch every aspect of society, from digital terrorism to bioengineering to brain hacking and neural cryonics to swarm warfare, digital assets, intelligent weapons, trillions of IoT connected devices the list goes on.

As a society, we should be open to innovation and the benefits it ushers in. At the same time, we must also remain committed to sustainable tech development and a deployment mechanism that does not fail to shine a light on human dignity, economic inequality and broad inclusiveness. These seem like esoteric issues, but they are not, and they are being put to the test by COVID-19.

A fresh example of this thematic happened recently: Tim Bray, a VP and engineer at Amazons AWS, resigned because of the companys treatment of employees, and was quoted as saying, in part, Amazon treats the humans in the warehouses as fungible units of pick-and-pack potential. Only thats not just Amazon, its how 21st-century capitalism is done If we dont like certain things Amazon is doing, we need to put legal guardrails in place to stop those things.

Eliminating human agency has been at the core of innovation during the last four decades. Less human intervention in a call center, a hedge fund trading desk, a factory, a checkout line or a motor vehicle seems fine but in cases of greater importance, humans should remain more active or we will, at best, make ourselves irrelevant. In the past, labor displacement has been temporary, but it seems to me that the next wave is likely to be different in terms of the permanence of labor allocation, and big tech getting bigger will likely hasten this.

Innovative capability has been at the center of progress and living standard improvements since we harnessed fire. The worlds technology portfolio is an exciting one, but potentially terrifying to those who could be more hampered by it, such as the front-line workers on Main Street shouldering the health and economic brunt of the coronavirus.

Years ago, Peter Drucker pointed out that technology has transformed from servant to master throughout our history. Regarding the assembly line, he noted that it does not use the strengths of the human being but, instead, subordinated human strengths to the requirements of the machine.

In my opinion, Druckers quote is at the very core of our point in time, happening on a scale and speed that is hard to fathom and changing the digital divide amongst us into a digital canyon between us and technology.

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Technology and ethics in the coronavirus economy - TechCrunch

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In August 1989, scientists made a blockbuster discovery: They pinpointed the faulty gene that causes cystic fibrosis, a cruel lung disease that killed many of its victims before they reached adulthood.

The human genome was uncharted territory, and the gene hunt had become an all-out international race, with laboratories in three countries searching for the root of the disease.

That fall, biologist James Wilson stood before an audience of researchers, physicians and cystic fibrosis patients and their families and described gene therapy, a way to replace the faulty gene with a good copy. Wilson had intended his talk to be technical and prophetic, but he was overwhelmed by the surging thrill in the room that science was about to save peoples lives.

It was one of the most amazing experiences that Ive ever had, Wilson said, adding, The expectations were through the roof.

The importance of the cystic fibrosis gene discovery went far beyond a single illness. It helped build the case for the $3 billion project to sequence the entire human genome, which would alter understanding of human biology and shed light on rare and common diseases.

But the story of cystic fibrosis has been illustrative in a way that no one could have anticipated back then. In the early days of human genetics, the path seemed straightforward: Find the gene, fix the gene and repeat for other diseases. The cystic fibrosis journey, from an exuberant moment of insight to a major success, would take 30 years of persistent, methodical work: a feat of science, business, fundraising and patience that has become a model for other diseases.

I specifically remember sitting with my doctor in the exam room, having the conversation that the gene was discovered, said Josh Taylor, 48, of Virginia Beach, who has cystic fibrosis. And him telling me the cure is just he literally said, In 5 to 10 years, were going to beat this.

It was not until late 2019 that another breakthrough fulfilled many of the hopes of 1989. Now, Taylor has what he has been waiting for all these decades a new drug, Trikafta, that is effective for 90 percent of patients. Doctors marvel at what they think will be possible if it is given at an early age: a full life span.

Cystic fibrosis developed when a child had the bad luck to inherit two faulty genes, one from each parent. Back then, there was no test to detect whether a parent carried a defective gene because no one even knew what the gene was.

As scientists developed new tools to probe human genetics, cystic fibrosis quickly became one of the top targets. It is the most common inherited disease among Caucasians, afflicting 30,000 Americans, and its motivated patient group spurred the work forward with funding.

All these human disease genes were floating around. We knew they were inherited, but we knew very little. We didnt know what the genes were, or where they were located, said Robert Nussbaum, a medical geneticist who was hunting genes for other diseases.

Francis Collins, now director of the National Institutes of Health and then a scientist at the University of Michigan working on cystic fibrosis, was photographed for the universitys graduates magazine sitting in a haystack holding a needle, to convey the magnitude of the technical challenge.

Almost everybody knew some family where it had happened, and it was heartbreaking to see what these kids go through, Collins said.

Robert Beall, then an executive vice president at the Cystic Fibrosis Foundation, which was funding the work, was also the most impatient human being I ever met to his credit, Collins said.

Collins partnered with biologist Lap-Chee Tsui, in Toronto holding joint lab meetings at a midway point on the long drive, in London, Ontario.

After years of work, Tsuis lab had narrowed the search to ever smaller stretches of DNA, pioneering new techniques in the search for the gene. Collins had invented a method to speed up the process called chromosome jumping, which allowed scientists to leap over sections of DNA something he compares to leaping from one street corner to the next to initiate searches. Jack Riordan, another scientist in Toronto, discovered a bit of DNA that looked like it might be a part of the gene, providing an essential lead.

In May, a scientist in Tsuis lab found a tantalizing clue three missing letters of DNA in a patient with cystic fibrosis. The team would need to confirm that this genetic mutation was the cause of the disease. Collins and Tsui were at a scientific conference at New Haven, Conn., a month later when they got more evidence.

One rainy night after the days program was over, the pair raced to Tsuis room, where he had installed a portable fax machine to receive updates from the lab. Among the papers that had spilled onto the floor was a table showing those three letters of DNA missing in multiple patients with cystic fibrosis, while they were present in healthy people.

Lap-Chee was a little more skeptical, Ive got to see more data, Collins recalled. I bought it, that was it. I wanted to scream and jump up and down.

The news report triggered frantic preparations to present the findings officially, and the work was published in Science magazine that September in three papers.

Collins would testify before Congress that it was necessary to fund the human genome project because the flat-out effort to find the cystic fibrosis gene simply would not be scalable in trying to understand thousands of other diseases.

Gene therapy, the thinking went, would soon cure cystic fibrosis, marking a turning point in the treatment of genetic diseases. The idea was relatively straightforward: Use a virus to ferry a good, functioning copy of the gene into patients lung cells.

But human biology turned out to have all sorts of ways of resisting an easy fix, and it quickly became clear that gene therapy would not be simple in real lungs.

Then the entire gene therapy field screeched halted in 1999 with the death of Jesse Gelsinger, a teenager with a metabolic disorder who died after being treated for the disorder in one of Wilsons gene therapy trials.

As the hope for a high-profile gene therapy success crashed, research continued on the basic, less glamorous work to untangle what went wrong with the cystic fibrosis gene. That understanding made it possible to develop ways to screen chemicals, to see if any showed promise as a drug.

Beall and Preston Campbell of the Cystic Fibrosis Foundation visited Aurora Biosciences, a San Diego biotech company that used robotics to massively speed up such testing.

Bob and I were like kids in a candy shop, Campbell recalled. After a small initial investment, the foundation stunned the nonprofit world in 2000 by awarding the company $40 million, a new kind of venture philanthropy arrangement in which if the company was successful, the nonprofit group would receive a share of the royalties.

A Massachusetts company, Vertex Pharmaceuticals, acquired Aurora in 2001, and although the cystic fibrosis work continued, it was considered a long shot, called the fantasy project internally, recalled Fred Van Goor, a scientist who joined the company around that time and became the biology lead for the cystic fibrosis program.

The scientific problem was huge: The most common gene mutation in cystic fibrosis created a protein that couldnt do its essential job in the cell. The protein didnt fold correctly, which interfered with its ability to reach the surface of the cell. And it didnt function well once there, where it was supposed to work as a gate. That meant theyd need multiple drugs to help patients one to get the protein to the right spot, the other one to open the gate.

Vertexs first drug candidate was focused on just one of the problems getting the gate to work better. Alone, it would help only about 4% of patients, whose disease was caused by a rare mutation. That drug, Kalydeco, was approved in 2012, but it remained unclear whether a drug could be made that would work for a larger group of patients.

Then, Vertexs main product a hepatitis C drug was eclipsed by a better treatment from a competitor, and the future of the company and its cystic fibrosis research was cast in doubt.

It obviously created an incredible crisis here at Vertex, said Jeff Leiden, chief executive of the company.

Vertexs board decided to bet on cystic fibrosis, and in 2015, a two-drug combination called Orkambi, was approved for a larger group of cystic fibrosis patients. Excitement about the drugs began to yield to a societal debate about their high prices; Orkambis launch price was $259,000 a year.

Meanwhile, the company would need to develop a third drug to treat more patients.

Drug trials are blinded so that neither the patients nor the scientists know which people are receiving the drug and which are receiving a placebo. When Trikafta, the triple drug combination that would ultimately be approved, was unblinded from one trial in October 2018, researchers finally saw the slide showing how the drug affected lung function.

There was a stunned silence in the room for a full minute. The drug worked.

Ten percent of cystic fibrosis patients, or about 3,000 people in the United States, are still waiting for a therapy that works for them.

Stacy Carmona, who was born just three years before the gene was discovered, is one of them.

Im so excited for the community. Im so excited for the CF friends I have who so desperately need the drug. There are so many people hanging on by a thread, waiting for this, Carmona said. The flip side of that is you cant help but wonder when is it going to be my turn?

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A cystic brosis success story -- over 30 years | Health - The Union Leader

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In 2014, a sardonic tweet about the differences between mens and womens deodorant descriptors went viral. It read: Women's deodorant scents: rose, cotton, spring, meadow. Mens: WINTER ICE, SHARKNADO, GLACIER PUNCH, ANTIFREEZE, GUN. The tweet, which was shared more than 24,000 times, inspired scores of similar, fabricated product names poking fun at the gendered way in which skincare and grooming products are typically marketed to men and women.

Satire aside, anyone browsing the toiletries aisle cant help but be aware of the invisible barrierand, more often than not, the clearly marked signsseparating the droves of baby-pink, pastel and powder-blue womens skincare products from the mostly monochromatic mens grooming choices, reassuring prospective purchasers that they are, in fact, suitable for men. Aside from the potentially harmful psychological effects of gender-specific marketing, the very real pink tax fosters another type of inequityin 2015, a study commissioned by the New York City Department of Consumer Affairs uncovered that, on average, personal-care products marketed to women will cost up to 13 per cent more than similar products targeted at men.

As we move towards more inclusive definitions of gender, is gendered skincare simply an antiquated (and sexist) marketing ploy or does it truly cater to the distinct needs of male and female skin compositions?

Its no secret that industry insiders have known for a while now that gender in consumption is often nothing more than a social construct. Were conditioned from a young age to classify certain colours, toys and products as feminine, while we gradually learn to think of others as specifically masculine. Just think of the toys you giddily unwrapped before tucking into your Happy Meal as a childdolls for the girls, cars for the boys.

This phenomenon continues to inform our thinking well into adulthood, with men tending to be more concerned with maintaining a masculine identity and choosing to buy products that align themselves with that image; its even been shown that men purchase more in the presence of a strong-looking man. Such intelligence is invaluable for marketers determined to bolster their bottom line.

Marketing strategies and social conditioning notwithstanding, is mens skin really different enough to warrant an entirely separate skincare regimen? While its true that mens skin is between 20 and 25 per cent thicker than womens (as it contains more collagen and elastin) and it tends to produce more oil, the American Academy of Dermatology assures us that the basics of our daily skincare regime should be the same, regardless of gender. Instead of thinking of skin as either male or female, the most important factors to look out for when putting together an effective skincare routine are skin type (normal, sensitive, oily, dry or combination) and areas of concernthink anti-ageing, blemishes, dark spots, and so on.

With consumers everywhere increasingly casting a critical eye on traditional beauty norms, the past few years have witnessed a sharp rise in gender-neutral skincare. Well-established brands and products that have long positioned themselves as neutral go-tos such as Australian heavyweight Aesop and ubiquitous unisex fragrances, including CK One, are now being joined by up-and-coming newcomers aiming to disrupt the gender-specific market.

Panacea, the K-Beauty-inspired skincare line, continues its hot streak in 2020. The brainchild of Korean-American co-founder Terry Lee, Panacea was conceived with the idea of introducing a gender-agnostic approach to skincare, while reducing the typical (and time-consuming) 10-step, K-Beauty approach to a mere three steps. The newest addition to the ever-expanding roster of universal pampering products is American Eagles in-house wellness and skincare line, Mood. This non-gendered range of hemp-derived CBD products includes everything from face oil and bath bombs to pillow mists.

Also looking to break down gender-specific beauty is Alll, which provides a personalised, DNA-based approach to skincare. Recent studies suggest our genetics account for 50 to 60 per cent of ageing, says Dr Elisabet Hagert, co-founder of Alll. This means how we age really is dependent on our genetic predispositions. Based on an in-depth DNA analysis, a bespoke skincare line is created, targeting individual concerns at a granular level regardless of gender.

As we progress into the new decade, were being spoiled for choice when it comes to skincare and grooming solutions with an emphasis on skin type and areas of concern, rather than gender. The only question that remains is this: with us men being fiercely brand loyal, will we be willing to leave our Sharknado-scented deodorants behind?

Is customisable skincare the future of the beauty industry?

A man explains why more men need to pay attention to skincare

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Skin deep: Is the future of skincare gender neutral? - VOGUE India

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The Medical Research Council (MRC) and independent medical research charity LifeArc are streaming 16 million into establishing a network of gene therapy innovation hubs.

The centres will offer clinical grade viral vectors as well as translational and regulatory guidance to support academic-led patient trials of new gene therapies.

Operating as 'centrally coordinated facilities', the hubs aim to address challenges faced by academics as they seek to advance novel gene therapy research into early stage clinical trials, such as a shortage of viral vector production capacity and a complex and evolving translational pathway for gene therapies.

LifeArc and the MRC said they will create the network by providing UK-based research organisations with grants for up to five years, to support the costs associated with expanding or repurposing existing viral vector production centres.

The selected centres, or hubs, will also have access to LifeArcs translation advice and support.

We hope that through this unique collaboration with the MRC, LifeArc can offer its funding and expertise in technology transfer and translational science to support the progression of promising gene therapies, said Dr Melanie Lee, the charity's chief executive. Translation of advanced therapies will be a core focus of LifeArcs future strategy for delivering significant new patient benefits.

MRC executive chair Professor Fiona Watt added: Through this partnership, we aim to support clinical development of the most exciting gene therapy projects from the UKs world-leading academic researchers. This investment will streamline and accelerate progress towards a new generation of genetic medicines for patients.

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LifeArc, MRC create 16m fund to set up gene therapy hubs - PharmaTimes

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SAN RAFAEL, Calif., May 3, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the company has entered into a preclinical collaboration and license agreement with DiNAQOR AG (DiNAQOR), a gene therapy platform company, to develop novel gene therapies to treat rare genetic cardiomyopathies. DiNAQOR will receive an undisclosed upfront payment and is eligible to receive development, regulatory and commercial milestones on product sales in addition to tiered royalties on worldwide sales. The company did not disclose financial terms. BioMarin management reiterated its 2020 GAAP net income guidance of $20 to $80 million, inclusive of this collaboration.

The license initially covers DiNAQOR's lead program, DiNA-001 for MYBPC3 hypertrophic cardiomyopathy (HCM). Additionally, the companies will collaborate on several of DiNAQOR's other pipeline programs, and BioMarin has the option to extend the license to include these additional programs on similar terms. Reflecting the long-term commitment to the collaboration, BioMarin is simultaneously investing in DiNAQOR.

"With this agreement, BioMarin is continuing to apply its gene therapy know-how and manufacturing expertise in new areas like cardiology," said Jean-Jacques Bienaim, Chairman and Chief Executive Officer at BioMarin. "This collaboration extends our global leadership position in gene therapy and boosts our potential to transform the lives of patients worldwide with rare genetic cardiomyopathies."

"We are thrilled to collaborate with the researchers at DiNAQOR to conduct this pioneering work on the development of gene therapies for inherited cardiomyophathies," said Lon Cardon, Chief Scientific Strategy Officer and Senior Vice President at BioMarin. "We believe there is tremendous potential in combining our experience in gene therapy research and development with DiNAQOR's in-depth knowledge of genetic heart diseases."

DiNAQOR was founded and is led by several leading pharmaceutical and biotechnology executives and academics with deep cardiology and gene therapy expertise. The company's holistic approach to gene therapy is focused on gene therapies for the heart that deliver a medical solution that can safely deliver gene therapies to the heart muscle, ensure transduction of the cardiac cells, and limit the exposure of the therapy to other organs.

"BioMarin is a global leader in rare disease research, development and commercialization, and their commitment to DiNA-001 is a powerful validation of DiNAQOR's gene therapy platform," said Dr. Johannes Holzmeister, Co-Founder, Chairman and CEO at DiNAQOR. "We believe our platform has many potential applications and this milestone agreement will enable us to invest in expanding our genetic medicine pipeline."

"Momentum for gene therapies continues to build, and BioMarin has demonstrated tremendous scientific, clinical, and manufacturing leadership and expertise in the space," said Thomas Voit, M.D., Ph.D., Co-Founder and Chief Scientific Officer at DiNAQOR and Director of the Biomedical Research Centre at the Great Ormond Street Hospital and the UCL Institute of Child Health, University College London. "We are looking forward to combining our strengths to expand the promise of gene therapy treatments by targeting the heart muscle to treat rare genetic cardiomyopathies."

About HCM and MYPBC3

Hypertrophic cardiomyopathy (HCM) is one of the most common genetic heart diseases, with about 500,000 patients diagnosed with HCM worldwide. Up to 60% of HCM cases have a genetic origin, and it is estimated that 40% of those have mutations in MYBPC3, the gene that encodes cardiac myosin-binding protein C (MyBP-C).

HCM affects the heart muscle, causing the muscle to enlarge. HCM patients have an increased risk of developing heart failure and life-threatening arrhythmias. There are no approved pharmacological treatment options available that address the underlying disease biology of HCM and invasive surgery or heart transplantation may be the only options available for patients with advanced disease.

About BioMarin

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for serious and life-threatening rare genetic diseases. The Company's portfolio consists of six commercialized products and multiple clinical and pre-clinical product candidates. For additional information, please visit http://www.biomarin.com. Information on BioMarin's website is not incorporated by reference into this press release.

About DiNAQOR

Founded in 2019, DiNAQOR AG is a global gene therapy platform company focused on advancing novel solutions for patients suffering from heart disease. The company's lead preclinical program, DiNA-001 is focused on the treatment of MYBPC3-linked cardiomyopathy. DiNAQOR is headquartered in Pfffikon, Switzerland, with additional presence in London, England and Boston, Massachusetts (US). For more information visit http://www.dinaqor.com.

Forward Looking Statement

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: BioMarin's expectations regarding the announced collaboration, the prospects for the lead and follow on pipeline products and it's 2020 GAAP profitability. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials; the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities concerning the programs; the ability to manufacture the product candidates, BioMarin's revenue for 2020, especially with the possible impact of COVID-19, and those other risks detailed from time to time under the caption "Risk Factors" and elsewhere in BioMarin's Securities and Exchange Commission (SEC) filings, including BioMarin's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and future filings and reports by BioMarin. BioMarin undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.

BioMarin is a registered trademark of BioMarin Pharmaceutical Inc.

Contacts:

Investors

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Traci McCarty

Debra Charlesworth

BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

(415) 455-7558

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View original content:http://www.prnewswire.com/news-releases/biomarin-extends-gene-therapy-leadership-with-dinaqor-in-a-preclinical-collaboration-and-license-agreement-to-develop-gene-therapies-for-rare-genetic-cardiomyopathies-301051582.html

SOURCE BioMarin Pharmaceutical Inc.

Company Codes: NASDAQ-NMS:BMRN

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BioMarin Extends Gene Therapy Leadership with DiNAQOR in a Preclinical Collaboration and License Agreement to Develop Gene Therapies for Rare Genetic...

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Hours after Gilead announced that an NIH trial testing their antiviral drug remdesivir in Covid-19 patients had succeeded, NIAID director Anthony Fauci sat on a couch in the Oval Office and gave the world the top-line readout.

The drug induced a 31% improvement on the primary endpoint of time to recovery: 11 days in the drug arm compared to 15 days in the placebo arm, he said, adding that patients taking the drug appeared less likely to die, with an 8% mortality rate in the drug arm compared to 11% in patients given the placebo.

The mortality data were not yet statistically significant, he cautioned but were trending in the right direction. Fauci, surrounded by President Trump, Vice President Mike Pence and several other advisors, said the news was a very optimistic sign in the hunt for treatments to fight the virus.

Although a 31% improvement doesnt seem like a knockout 100%, it is a very important proof of concept, he said. Because what it has proven, is that a drug has blocked this virus.

Fauci said more details would come and that the study would be submitted to a peer-reviewed journal. Trump, who deferred to Fauci in giving the readout, echoed Faucis commentary.

Its a beginning, that means you build on it, Trump said. But its a very positive event.

Shortly after the briefing, the New York Times reported that the FDA was preparing to issue an emergency use authorization for the drugs use in Covid-19. In an email to Endpoints News, the FDA did not confirm or deny the Times report, but a spokesperson said the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.

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BioMarin broadens its gene therapy horizons with a new R&D alliance in rare cardio cases - Endpoints News

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When the axons that extend from neurons break during a spinal cord injury, the result is often a lifelong loss of motor functioning, because vital connections from the brain to other body parts cannot be restored. Now, researchers from Temple Universitys Lewis Katz School of Medicine say they may have found a way to recover some functions lost to axon breaks.

The researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. Lin28 also helped repair injured optic nerves in the animals, they reported in the journal Molecular Therapy.

The Temple team zeroed in on Lin28 because its a known regulator of stem cells, meaning it controls their ability to differentiate into various cells in the body. The researchers examined the effects of Lin28 on spinal cord and optic nerve injuries using two mouse models: one that was engineered to express extra Lin28 and another that was normal and was given the protein after injury via a viral vector.

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All of the mice experienced axon regeneration, the researchers reported. But they found that the best results occurred in the normal mice that received Lin28 injections post-injury. In fact, in animals with optic nerve injuries, the axons regrew to the point where they filled the entire tract of the nerve.

Lin28 treatment after injury improved coordination and sensation in the mice, the researchers reported.

"We observed a lot of axon regrowth, which could be very significant clinically, since there currently are no regenerative treatments for spinal cord injury or optic nerve injury," said senior author Shuxin Li, M.D., Ph.D., professor of anatomy and cell biology at the Lewis Katz School of Medicine, in a statement.

RELATED: Gene therapy with 'off switch' restores hand movement in rats with spinal cord injury

Lin28 is already a target of interest, though it has garnered the most attention so far in cancer research. Startup Twentyeight-Seven Therapeutics is developing a small molecule that inhibits the protein in the hopes that doing so will boost Let-7, a cancer-suppressing microRNA. The company raised more than $82 million in a series A financing last year.

Several new approaches for repairing spinal cord injuries are under investigation, most notably gene therapy. King's College researchers are working on a gene therapy that repairs axons by prompting the production of the enzyme chondroitinase. A UT Southwestern team is targeting the gene LZK to increase levels of supportive nervous system cells called astrocytes in response to spinal injuries.

The Temple team has a two-pronged approach to further developing their Lin28-directed treatment. They hope to develop a vector that can be safely delivered by injection and that would deliver the therapy directly to damaged neurons. They also plan to study other molecules in the Lin28 signaling pathway.

"Lin28 associates closely with other growth signaling molecules, and we suspect it uses multiple pathways to regulate cell growth," Li said, potentially revealing other therapeutic molecules that could further boost neuron repair.

Originally posted here:
Repairing spinal cord injuries with a protein that regulates axon regeneration - FierceBiotech

Recommendation and review posted by Bethany Smith

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Summary

Its an understatement to say that Facebook has changed the world its created an ability for people to be transparent about their experiences, lives, and opinions, for better or worse. In the case of Homology, its for the latter. Homology, a gene therapy company whose technology has already been scrutinized by scientists as untrue, has just one product in clinical trials, HMI-102, for the rare disease phenylketonuria ("PKU"). As Med Genie reported back in January, FIXXs trial update showed interim phenylalanine (Phe) results that suggested HMI-102 was not efficacious for low and mid-dose patients. Our note today highlights a data point the company would very much like you not to know the only patient in FIXXs high dose cohort posted her results on Facebook, and they show that HMI-102 is unlikely to reach trial endpoints even at a high dose. We believe this patient was forced to take her posts down as a result, and management selectively disclosed the issue to the sell side, providing comments about the drugs safety, and conveniently ignoring the implications to efficacy and the business. Maybe they were hoping to raise capital before officially announcing trial results. Who knows? We believe that the HMI-102 program is dead in the water, and since its progress is the major driver of FIXXs value, we believe that the stock should trade to cash value, or $5.80, down 56% from the April 27th close.

Background

The best shorts are often one-trick ponies, but rarely do we find one where a single data point completely upends the long investment case. Homology Medicines, FIXX, is one of those rare finds.

Homology is a gene therapy company which has their first and lead product candidate, HMI-102, in a dose-escalation Phase 1/2 trial (pheNIX) for phenylketonuria. FIXX also has 2 IND-enabling programs and some discovery stage programs, but the HMI-102 trial is the companys main shot at viability.

PKU is a relatively rare disease, with a U.S. incidence of approximately 350 cases per year and a prevalence of just 16,500, per FIXXs 10-k. PKU is tied to mutations in the gene that control PAH, an enzyme that metabolizes phenylalanine, or Phe. The condition results in a deficiency in the enzymatic activity of PAH, causing an excess in Phe in the bloodstream that can result in intellectual disability. PKU patients are identified soon after birth, and are primarily treated with a Phe-restricted diet. FIXXs HMI-102 seeks to modify the underlying genetic cause of PKU, effectively curing the disease and allowing patients to eat normally and not experience the cognitive and metabolic issues from higher than normal Phe.

FIXXs technology, which does not use the CRISPR approach to gene therapy, has already been subject to scrutiny, with David Russell, a researcher at the University of Washington, saying, Whats surprising is this company raised so much money on something thought to be untrue in the scientific community, in a piece in MIT Technology Review.

We believe that recent revelations about the efficacy of HMI-102 support this skepticism and show that the drug is not efficacious, kicking out the one leg holding up FIXXs business, and that FIXX should trade to cash value, or $5.80 per share, down 56% from the April 27th closing price.

The pheNIX trial

The pheNIX trial for HMI-102 launched in June 2019, and its primary efficacy endpoint is two plasma Phe measurements below 360 umol/L (or 6 mg/dL) between 16 and 24 weeks after dosing. Following evaluation of the first two patients in a cohort, a decision can be made to either escalate to the next dose level, add a third patient or expand the cohort at the selected dose level.

Now before we review whats new, its helpful to note that a mouse study presented at the 21st Annual Meeting of the American Society of Gene & Cell Therapy titled Sustained Correction of Phenylketonuria by a Single Dose of AAVHSC Packaging a Human Phenylalanine Hydroxylase Transgene showed that HMI-102 showed an effect to mouse Phe levels just one week after dosing in fact, mouse Phe levels remained relatively flat after that first drop.

This would imply that the therapy shows its effect soon after dosing and the longer timelines contemplated in the study endpoints are to indicate that the effect is long lasting. Sure enough, we see a similar dynamic in the pheNIX trial data released by FIXX in December 2019. There were 3 patients examined here from the 10-k: (n=2 patients in the low-dose Cohort 1 and n=1 patient in the mid-dose Cohort 2) as of the data cutoff of December 2, 2019. A fourth patient was dosed in Cohort 2 subsequent to the data cutoff date and was therefore not included in the analysis.

In this release, we see the two patients in the low-dose cohort experienced no improvement in fasting Phe after dosing or even 12 weeks later. The cohort 2 patient, getting a mid-dose, showed an improvement in Phe level immediately after dosing, but their Phe level did not fall below the 360 umol/L threshold defined as the primary endpoint (it stayed around 500) calling into question the efficacy of the treatment, which Med Genie mentions in their piece (from the 10-k):

Damning revelations

On March 5, 2020, a woman we will call Miss A started a Facebook group (since made private or taken down on April 15, 2020) to discuss her experience getting gene therapy for PKU:

On March 9, 2020, Miss A, who lives in Normal, IL tells us shes going to Chicago, which happens to be one of the pheNIX trial sites:

The next day, Miss A provides us with enough to data to know that she is Patient 5, part of the high dose cohort 3 in FIXXs HMI-102 trial (cohort 3, mentioned by Miss A, would be the next dose up from the cohort 2, the mid-dose cohort):

Dr. Burton appears to be Dr. Barbara K. Burton, a physician focused on PKU at the Ann & Robert H. Lurie Childrens Hospital of Chicago, a trial site mentioned in the pheNIX trial description on clinicaltrials.gov:

This, taken together with the fact that Biomarins own PKU trial was in too early a stage to enroll a Cohort 3 patient in March 2020, its probably safe to say that Miss A is taking part in FIXXs pheNIX trial.

On March 11, Miss A receives her infusion:

Miss A then shares a series of updates on how she is feeling and the progress of her weekly visits post-infusion. Six days post infusion, she says she hasnt gotten any test results back, but that it may take 2 or 3 weeks to get a Phe level:

27 days post-infusion, Miss A tells a FB commenter that she wont get Phe levels till six weeks post-infusion:

And then 35 days post-infusion, on April 15, 2020, a bombshell Miss A gets her Phe levels, and at 25 mg/dL or 1497uMol/L, they are well above the 360 uMol/L endpoint threshold after 5 weeks (and after the drug typically takes effect), suggesting that HMI-102 is not efficacious even for a high dose patient:

Just a few hours after her post, Miss As entire group is either taken down or made private, perhaps at the demands of FIXX itself.

Management's disclosure problem

We believe that management was aware of this post and tried to manage the perception of it by talking to the sell side and to select investors. In fact, Oppenheimers equity sales desk was sharing the below email conversation between their analyst Matt Biegler and FIXXs Theresa McNeely to explain the price action on April 15th:

Who was Theresa planning to speak to? We know that Bairds Madhu Kumar got a call:

But when we asked Theresa ourselves, she was much less forthcoming:

It appears to us that FIXX chose to inform the sell side and potential larger investors, who appear to be selling the stock (it has dramatically underperformed biotech broadly), but not the average investor. This is a significant red flag that investors should be aware of.

Why all this matters

Because the mouse study and the Cohort 2 data showed an effect to Phe levels one week after dosing rather than a gradual reduction, we can conclude that Miss As level, at 1497 uMol/L, is probably not going to get better, unfortunately. Further, her levels several weeks into the trial are still much higher than the threshold level specified in the primary endpoint of 360 uMol/L. This means that the therapy is showing zero efficacy even for a high dose patient. This data point is damning given the size of the trial and importance of the high dose patient in light of the lack of efficacy in the low and mid-dose cohorts.

Now the sell side may parrot management and say that there is no way to know whether Miss A is who she says she is, but the evidence is certainly strong supporting her case. They may say that there was no way for her to know her Phe level, but her posts show that she expected to receive them. They may also say that the drug is safe, and that liver enzyme elevation should be expected in a therapy like HMI-102, but thats all beside the point. The point is that the Phe level Miss A received 5 weeks after infusion show that HMI-102 is not efficacious.

These results support the skepticism around FIXXs use of the AAVHSC vector in liver directed gene therapy, which, based on the results thus far, and in particular Miss As results, appear to show zero efficacy and thus makes it inferior to Biomarins AAV5 vector.

Furthermore, if management thought this information was material enough to talk to the sell side analysts covering the stock, why not put it in an 8-k or even a press release for the benefit of their entire shareholder base? Given the materiality of the information, wouldnt all shareholders have benefited from the same level of disclosure rather than be kept in the dark? This is behavior consistent with that of MDXG and ALLK, both companies with executives formerly from reputed companies who have seen their stock prices demolished.

For FIXX, we believe that this is a huge problem the HMI-102 pheNIX trial is the ONLY program in their portfolio that is in the Phase 1/2 stage, and thus the primary path to viability for the company. With this piece of data showing that HMI-102 is not efficacious, we believe that the program is likely worthless and unlikely to proceed to commercialization. While FIXX may try to apply HMI-102 to other indications, we believe that doing so would essentially restart the trial and approval clock without making up for the lost time to market from a failed PKU trial.

Furthermore, social media matters. While FIXX management may be dismissive of people posting on Facebook, these posts have value. In the case of Allakos (ALLK), Seligman Research put together a barn burner of a report which included numerous Facebook posts questioning the efficacy, safety, and trial design of ALLKs drug candidate. Since that report, ALLK stock is down approximately 51%, and ALLK actually has several later stage trials.

In the case of FIXX, we believe that HMI-102 in PKU is the ONLY path to viability given the lack of efficacy of HMI-102 at high dose, we believe that the HMI-102 program is dead, and that the stock should trade to its cash value per share, or $5.80 per share, down 56% from the April 27th close price.

Disclosure: I am/we are short FIXX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: This piece is our opinion and not an offer to buy/sell any securities. We're biased, you're biased, so do your own work and make your own decisions.

Link:
Can't FIXX This - We Believe Homology's HMI-102 Is In Trouble - Seeking Alpha

Recommendation and review posted by Bethany Smith

After a comprehensive analysis, Mrinsights.bizhas published a new research study titled GlobalHemophilia Gene Therapy Market Growth 2020-2025 that covers the latest and upcoming industry trends and offers a global spectrum of the Hemophilia Gene Therapy market, and future forecast from 2020 to 2025 years. The market is bifurcated into product type, application, key manufacturers and key regions and countries. The research assists users to achieve competitive leverage with acquiring and preserving market position as key aims of the program. The report expands on details pertaining to contributions by key players, demand and supply analysis as well as market share growth of the industry.

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It covers the leading manufacturers profiles involving market entry strategies, production analysis, market share, revenue forecast. In addition, the regional analysis of the industry is offered where the report delivers analytical information on regional segmentation. Top leadingcompaniesof global Hemophilia Gene Therapy market are:Spark Therapeutics, Ultragenyx, Sangamo Therapeutics, Bioverativ, Shire PLC, Freeline Therapeutics, BioMarin, uniQure

Industry Trends And Opportunities:

The report provides an investigation into the global Hemophilia Gene Therapy market status, shares, supply-demand, market drivers, challenges and opportunities, and geological areas. Key trends and development opportunities are covered in this analysis report. The report then serves information on sales and market share estimates by-product as well as a profile of the companys business.

Regional Analysis:

This research report consists of the worlds crucial region Hemophilia Gene Therapy market share, size (volume), trends including the product profit, price, value, production, capacity, capability utilization, supply, and demand and industry growth rate. It helps readers to understand strategies to make sound investments. The regions are extensively analyzed with respect to every parameter of the geographies in question, comprising: Americas (United States, Canada, Mexico, Brazil), APAC (China, Japan, Korea, Southeast Asia, India, Australia), Europe (Germany, France, UK, Italy, Russia, Spain), Middle East & Africa (Egypt, South Africa, Israel, Turkey, GCC Countries).

The Report Addresses The Following Queries Related To The Market:

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Furthermore in this report, external as well as internal factors that are supposed to affect the business positively or negatively have been investigated. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors by region on the global Hemophilia Gene Therapy market is given in the report. A further section of the report discusses expansion plans of companies, key mergers and acquisitions, funding and investment analysis, company establishment dates, revenues of manufacturers, and their areas served and manufacturing bases.

Customization of the Report:This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs. You can also get in touch with our executives on +1-201-465-4211 to share your research requirements.

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Global Hemophilia Gene Therapy Market 2020 Top Companies, Industry Demand, Business Review and Regional Analysis by 2025 Cole Reports - Cole of Duty

Recommendation and review posted by Bethany Smith

The Gene Therapy Market report market intelligence study intended to offer complete understanding of global market scenario with the Impact of COVID-19 (Corona Virus). It attempts to analyze the major components of the Market which have greater influence on it. This includes various elements of significant nature including market overview, segmentation, competition landscape, Market chain analysis, key players stratergyand more. Also, the report provides a 360-degree overview of global market on the basis of various analysis techniques including SWOT and Porters Five Forces. Approximations associated with the market values over the forecast period are based on empirical research and data collected through both primary and secondary sources. This might help readers to understand the strengths, opportunities, challenges and perceived threats of the market.

Based on Classification, each type is studied as Sales, Market Share (%), Revenue (Million USD), Price, Gross Margin and more similar information. The report can help to realize the market and strategize for business expansion accordingly. In the strategy analysis, it gives insights from marketing channel and market positioning to potential growth strategies, providing in-depth analysis for new entrants or exists competitors in the Gene Therapy industry.

The Gene Therapy Market report wraps:

There are 13 Chapters to thoroughly display the Gene Therapy market. This report included the analysis of market overview, market characteristics, industry chain, competition landscape, historical and future data by types, applications and regions.

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

Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

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Gene Therapy Market to witness impressive Growth in Production-Consumption Ratio through 2026 - Latest Herald

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass., May 04, 2020 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, today announced the appointment of Stephen Webster to its Board of Directors. With nearly 30 years of biotechnology industry experience in raising capital, business development transactions and operations, Mr. Webster has played important roles as the Chief Financial Officer of Spark Therapeutics, Optimer Pharmacuticals and Adolor Corporation. In connection with Mr. Websters arrival, Mitchell Finer, Ph.D., will be stepping down from the Board of Directors effective May 4, 2020 but will continue to serve TCR2 in an advisory capacity.

"We are delighted to welcome in another successful cell and gene therapy executive as Stephen Webster joins our Board of Directors. His distinguished track record of leading companies through periods of growth will prove invaluable at this moment in time as we prepare to present clinical data for our two lead programs, TC-210 and TC-110, and advance a third mono TRuC-T cell therapy towards the clinic," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "His business development transaction expertise will be particularly useful in helping us strike the right partnerships in pursuing our goal of developing innovative T cell therapies for patients suffering from cancer.

Mr. Webster served as the Chief Financial Officer of Spark Therapeutics, a publicly traded gene therapy biotechnology company, from July 2014 until its acquisition by Roche for $4.3 billion in December 2019. He was previously Senior Vice President (SVP) and Chief Financial Officer of Optimer Pharmaceuticals, a publicly traded biotechnology company, from July 2012 until its acquisition by Cubist Pharmaceuticals in October 2013. Prior to joining Optimer, Mr. Webster served as SVP and Chief Financial Officer of Adolor Corporation, a biopharmaceutical company, from 2008 until its acquisition by Cubist Pharmaceuticals in 2011. Mr. Webster also served in leadership positions in the investment banking healthcare groups of Broadpoint Capital and PaineWebber Incorporated.

Mr. Webster has served as a director of Nabriva Therapeutics AG (formerly Nabriva Therapeutics plc), a publicly traded biopharmaceutical company, since August 2016 and Viking Therapeutics, a publicly traded biopharmaceutical company, since May 2014. Mr. Webster received an A.B. in Economics from Dartmouth College and an M.B.A. in Finance from The Wharton School of the University of Pennsylvania.

I am thrilled to become a director of TCR2 Therapeutics, where there is a great opportunity to turn a distinctive TRuC-T cell platform into a series of novel treatments of cancer, said Mr. Webster. I look forward to working with the TCR2 leadership team and Board of Directors to add my business development expertise in helping the Company achieve its goal of bringing transformational therapies to people living with serious solid tumors and hematologic malignancies.

On behalf of TCR2 and the Board of Directors, I would like to thank Mitchell Finer for his many contributions to the rapid growth of our company, added Dr. Menzel. Our strategy to begin with an automated cell therapy manufacturing process benefited from working very closely with Dr. Finer, whose three decades of cell therapy manufacturing leadership provided us a significant competitive advantage in the cell therapy landscape. We look forward to continuing to benefit from his insights as he transitions from a Board member to a consultant.

About TCR2 Therapeutics

TCR2Therapeutics Inc.is a clinical-stage immunotherapy company developing the next generation of novel Tcell therapies for patients suffering from cancer.TCR2sproprietary T cell receptor (TCR) Fusion Construct Tcells (TRuC-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent ofhuman leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while exhibiting lower levels of cytokine release. The Companys lead TRuC-T cell product candidate targeting solid tumors, TC-210, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Companys lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR2, please visitwww.tcr2.com.

Forward-looking Statements

This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the development of the Companys product candidates, future business plans and the therapeutic potential of its product candidates and platform.

The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR2s ongoing operations; and other risks set forth under the caption "Risk Factors" in TCR2s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with theSecurities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.

Moreover, except as required by law, neither TCR2nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investor and Media Contact:

Carl MauchDirector, Investor Relations and Corporate CommunicationsTCR2 Therapeutics Inc.(617) 949-5667carl.mauch@tcr2.com

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TCR Therapeutics Announces Veteran Finance Executive Stephen Webster Joins its Board of Directors - GlobeNewswire

Recommendation and review posted by Bethany Smith

The Global CRISPR technology market is expected to reach USD 1,715 million by 2023 from USD 562 million in 2018, at a CAGR of 25%

The rising funding from government and private organizations and the high adoption of CRISPR technology are major factors driving the growth of CRISPR technology market002E

How much is the CRISPR Technology Market worth?

MarketsandMarkets forecasts the CRISPR technology market is expected to reach USD 1,715 million by 2023 from USD 562 million in 2018, at a CAGR of 25% during the forecast period. The global CRISPR services market is segmented into four major regions, namely, North America, Europe, the Asia Pacific, and the Rest of the World.

In 2018, North America accounted for the largest share of this market majorly due to the rising government and private funding, presence of major pharma and gene therapy companies, and the adoption of CRISPR in a number of applications.

The CRISPR products segment is expected to command the largest share of the CRISPR Products market during the forecast period.

The CRISPR Products market, by product and service, is estimated to be dominated by the products segment in 2018. This is attributed to the fact that the CRISPR Products is being adopted quickly by academics and researchers, pharma and biotech companies.

The enzymes segment is expected to account for the largest share of the products market, being one of the key ingredients in the CRISPR process. Companies like Merck KGaA and Thermo Fisher Scientific are providing hands-on training to researchers, which will increase the demand for CRISPR products in the future.

Download PDF Brochure @ http://www.marketsandmarkets.com/pdfdown=134401204

Biomedical applications to occupy the majority of the market, by application, and grow at the fastest rate during the forecast period.

The biomedical applications segment is projected to be the fastest-growing segment of the CRISPR services market, by application, during the forecast period. Developments in gene therapy, drug discovery, and diagnostics, due to the application of CRISPR, are driving the growth of this biomedical segment.

Many companies have also invested in drug discovery and gene therapy companies that are using CRISPR technology.

North America is expected to account for the largest market share during the forecast period.

North America is estimated to account for the largest share of the CRISPR services market in 2018. This is majorly attributed to the rising government and private funding, presence of major pharma and gene therapy companies, and the adoption of CRISPR in several applications.

Furthermore, crops that are treated with CRISPR-based gene editing are not considered as GMOs in US; this has attracted a number of agricultural companies to focus on the commercialization of CRISPR-edited crops.

Request for Sample Pages @ http://www.marketsandmarkets.com/request=134401204

Who are the leading vendors operating in CRISPR Services Market?

Cellecta, Inc. (US), Thermo Fisher (US), GeneCopoeia, Inc. (US), Applied StemCell (US), Synthego Corporation (US), OriGene Technologies (US), Horizon Discovery (UK), Merck (Germany), and GenScript (US).

Thermo Fisher Scientific has established its presence in diversified life sciences markets; this has helped it to minimize risks and dependency on any business segment. The company has a strong product portfolio and brand image, which enables it to strengthen its position in the market.

The company has initiated a promotional campaign in which it conducts workshops and provides hands-on training to researchers in academic and research institutes working on CRISPR. This campaign is being organized to spread awareness on and promote CRISPR technology.

To speak to our analyst for a discussion on the above findings, clickSpeak to Analyst

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CRISPR Technology Market worth USD 1715 million by 2023 according to a new research report - WhaTech Technology and Markets News

Recommendation and review posted by Bethany Smith

Cancer Gene Therapy Marketis expected to reach 5075 million by 2026 from XX million in 2018 at CAGR of XX %.

The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.

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Cancer Gene Therapy Research Report is a method of therapeutic delivery of genetic material into a patients cells as a drug to treat disease and compensate for abnormal genes or to make a beneficial protein. Cancer cells modify themselves (called faults or mutations) in several of their genes which make them divide very often and form a tumor. Gene therapy provides various methods by which doctors can cure cancer like:

Inactivation of a mutated gene that is functioning improperly. Introducing a new gene into the body to help fight a disease. Replacement of mutated gene that causes disease with a healthy copy of the gene.Cancer caused 9.02 million deaths in 2017, and is expected to reach 10 million by 2026; the increased no of cancer prevalence is because of increased body mass index, low fruit and vegetable intake, lack of physical activity, increased tobacco and alcohol consumption. Also, Factors like increasing ethical acceptance of gene therapy for treatment of diseases and growing popularity of DNA vaccines, High success rate during the preclinical and clinical trial, Increase in funding for R&D in cancer gene therapy, Increase in geriatric population, favorable government regulations will fuel the global Cancer Gene therapy market. However, the high cost of gene therapy treatment and unwanted immune responses will restrain market growth.The highest revenue-generating region is North America in 2017 followed by Europe; reasons behind this increased growth rate are well-established health care facilities, high per capita health care expenditure, and extensive R&D activities for the gene therapy in the region. However, Asia Pacific is projected to expand at a moderate growth rate during the forecast period.

Key Highlights:

Assessment of market definition along with the identification of key players and an analysis of their strategies to determine the competitive outlook of the market, opportunities, drivers, restraints, and challenges for this market during the forecast period Comprehensive analysis of factors instrumental in changing the market scenario, rising prospective opportunities, market shares, growth strategies that can In-depth analysis of the industry on the basis of market segments, market dynamics, market size, competition & companies involved value chain Cancer Gene Therapy market analysis and comprehensive segmentation with respect to the therapy and geography to assist in strategic business planning Cancer Gene Therapy market Research Report analysis and forecast for five major geographies North America, Europe, Asia Pacific, Middle East & Africa, Latin America, and their key countries Complete quantitative analysis of the industry from 2017 to 2026 to enable the stakeholders to capitalize on the prevailing market opportunities.For company profiles, 2017 has been considered as the base year. In cases, wherein information was unavailable for the base year, the years prior to it have been considered.

DO INQUIRY BEFORE PURCHASING REPORT HERE:https://www.maximizemarketresearch.com/inquiry-before-buying/520/

Research Methodology:

An objective of the study is to estimate the size of the Cancer Gene Therapy market for 2017 and projects its demand till 2026 with quantitative and qualitative analysis of Cancer Gene Therapy market. Industry experts have studied various industry journals, directories, have referred information available with various associations to identify, collect information and to put it in articulated format to make useful for all stake holders in the industry. Primary research has been done and various industry experts and suppliers from worlds wide have given their inputs to make the study more accurate.Key Players in the Cancer Gene Therapy Market Are:

Shenzhen Sibiono Genetech Adaptimmune Glaxosmithkline Oncogenex Pharmaceuticals Bluebird Bio, Inc. Synergene Therapeutics Shanghai Sunway Biotech Biocancell Celgene MerckKey Target Audience:

Cancer Gene Therapy Market Investors Cancer Gene Therapy Marketing Players Pharmaceutical and Biotechnology Companies Healthcare Institutions (Individual Surgeons, Medical Schools, Group Practices, Hospitals, and Governing Bodies) Diabetes Drugs Market Research Associations Diabetes drug Manufacturers & DistributorsScope of the Cancer Gene Therapy Market

Research report categorizes the Cancer Gene Therapy market based on Therapy and geography (region wise). Market size by value is estimated and forecasted with the revenues of leading companies operating in the Cancer Gene Therapy market with key developments in companies and market trendsCancer Gene Therapy Market, By Therapy:

Oncolytic Virotherapyo Adenoo Lentiviruso Retro Viruso Adeno Associated Viruso Herpes Simplex Viruso Alpha Viruso Vaccinia Viruso Simian Viruso Others Gene Transfero Naked Plasmid Vectoro Electroporationo Sonoportiono Magnetofectiono Gene Gun Gene-Induced Immunotherapyo Delivery of Cytokines Geneo Delivery of Tumor Antigen GeneCancer Gene Therapy Market, By Geography:

North America Europe Asia Pacific Middle East & Africa Latin America

MAJOR TOC OF THE REPORT

Chapter One: Cancer Gene Therapy Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Cancer Gene Therapy Market Competition, by Players

Chapter Four: Global Cancer Gene Therapy Market Size by Regions

Chapter Five: North America Cancer Gene Therapy Revenue by Countries

Chapter Six: Europe Cancer Gene Therapy Revenue by Countries

Chapter Seven: Asia-Pacific Cancer Gene Therapy Revenue by Countries

Chapter Eight: South America Cancer Gene Therapy Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Cancer Gene Therapy by Countries

Chapter Ten: Global Cancer Gene Therapy Market Segment by Type

Chapter Eleven: Global Cancer Gene Therapy Market Segment by Application

Chapter Twelve: Global Cancer Gene Therapy Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Cancer Gene Therapy Market Report at:https://www.maximizemarketresearch.com/market-report/cancer-gene-therapy-market/520/

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Cancer Gene Therapy Market : Research Report - MR Invasion

Recommendation and review posted by Bethany Smith

The report aims to provide an overview of Global Assistive Technologies for Visual Impairment Market along with detailed segmentation of market by applications, end-users and five major geographical regions. Global Assistive Technologies for Visual Impairment market is expected to witness an aggressive growth during the forecast period.

Leading players of Assistive Technologies for Visual Impairment Market:VFO Group, TQM, Humanware, Handy Tech Elektronik GmbH, Perkins Solutions, Papenmeier, Amedia, Eurobraille, Nippon Telesoft, Brailletec, VisionCue

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Segmentation by Type:Braille Displays

Note Takers

Magnifiers

Braille Printers and Embossers

Braille Writers

Segmentation by Application:Blind School

Disabled Persons Federation and Hospital

Enterprises and Social Organizations

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Exclusive Research Report on Assistive Technologies for Visual Impairment Market, Size, Analytical Overview, Growth Factors, Demand and Trends...

Recommendation and review posted by Bethany Smith

The Enzyme Replacement Therapy Market report market intelligence study intended to offer complete understanding of global market scenario with the Impact of COVID-19 (Corona Virus). It attempts to analyze the major components of the Market which have greater influence on it. This includes various elements of significant nature including market overview, segmentation, competition landscape, Market chain analysis, key players stratergyand more. Also, the report provides a 360-degree overview of global market on the basis of various analysis techniques including SWOT and Porters Five Forces. Approximations associated with the market values over the forecast period are based on empirical research and data collected through both primary and secondary sources. This might help readers to understand the strengths, opportunities, challenges and perceived threats of the market.

Based on Classification, each type is studied as Sales, Market Share (%), Revenue (Million USD), Price, Gross Margin and more similar information. The report can help to realize the market and strategize for business expansion accordingly. In the strategy analysis, it gives insights from marketing channel and market positioning to potential growth strategies, providing in-depth analysis for new entrants or exists competitors in the Enzyme Replacement Therapy industry.

The Enzyme Replacement Therapy Market report wraps:

There are 13 Chapters to thoroughly display the Enzyme Replacement Therapy market. This report included the analysis of market overview, market characteristics, industry chain, competition landscape, historical and future data by types, applications and regions.

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

Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

Originally posted here:
Enzyme Replacement Therapy Market Forecast: By Regions, Type and Application with Sales and Revenue Analysis 2020-2026 - Latest Herald

Recommendation and review posted by Bethany Smith

Facts & Factors Market Research, a leading market research and consulting firm added the latest industry outlook report on Cancer Gene Therapy Market By Type (Ex-vivo and In-vivo) and By Product (Viral Vectors, Non-viral Vectors, and Others): Global Industry Outlook, Market Size, Business Intelligence, Consumer Preferences, Statistical Surveys, Comprehensive Analysis, Historical Developments, Current Trends, and Forecasts, 20202026 consisting of 190+ pages during the forecast period 2019 to 2026 and the Cancer Gene Therapy Market report offers comprehensive research updates and information related to market growth, demand, and opportunities in the Cancer Gene Therapy Market.

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The Major Market Players Dominating this Cancer Gene Therapy Market for its Products, Services, and Continuous Product Developments are:

Vigene Biosciences, Sirion Biotech, Bluebird bio, Cellectis, Ziopharm, Cobra, Uniqure, Finvector, Sarepta Therapeutics

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Regions and Countries Level Analysis

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Cancer Gene Therapy Market Size, Share, Growth Drivers Analysis in a new research report Forecast 2020-2026 - Northwest Trail

Recommendation and review posted by Bethany Smith

Shandong Huge

Global Dental Consumables And Dental Instruments Market: Competitive Landscape

This section of the report lists various major manufacturers in the market. The competitive analysis helps the reader understand the strategies and collaborations that players focus on in order to survive in the market. The reader can identify the players fingerprints by knowing the companys total sales, the companys total price, and its production by company over the 2020-2026 forecast period.

Global Dental Consumables And Dental Instruments Market: Regional Analysis

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The Dental Consumables And Dental Instruments market report was prepared after various factors determining regional growth, such as the economic, environmental, technological, social and political status of the region concerned, were observed and examined. The analysts examined sales, production, and manufacturer data for each region. This section analyzes sales and volume by region for the forecast period from 2020 to 2026. These analyzes help the reader understand the potential value of investments in a particular country / region.

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Tags: Dental Consumables And Dental Instruments Market Size, Dental Consumables And Dental Instruments Market Trends, Dental Consumables And Dental Instruments Market Growth, Dental Consumables And Dental Instruments Market Forecast, Dental Consumables And Dental Instruments Market Analysis

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Dental Consumables And Dental Instruments Market Size by Top Key Players, Growth Opportunities, Incremental Revenue , Outlook and Forecasts to 2026 -...

Recommendation and review posted by Bethany Smith

As the novel coronavirus swept through communities around the world, preying disproportionately on the poor and the vulnerable, one disadvantaged group has demonstrated a remarkable resistance. Women, whether from China, Italy or the U.S., have been less likely to become acutely ill and far more likely to survive.

Which has made doctors wonder: Could hormones produced in greater quantities by women be at work?

Now scientists on two coasts, acting quickly on their hunches in an effort to save mens lives, are testing the hypothesis. The two clinical trials will each dose men with the sex hormones for limited durations.

Last week, doctors on Long Island in New York started treating Covid-19 patients with estrogen in an effort to increase their immune systems, and next week, physicians in Los Angeles will start treating male patients with another hormone that is predominantly found in women, progesterone, which has anti-inflammatory properties and can potentially prevent harmful overreactions of the immune system.

Theres a striking difference between the number of men and women in the intensive care unit, and men are clearly doing worse, said Dr. Sara Ghandehari, a pulmonologist and intensive care physician at Cedars-Sinai in Los Angeles who is the principal investigator for the progesterone study. She said 75 percent of the hospitals intensive care patients and those on ventilators are men.

And pregnant women, who are usually immunocompromised but have high levels of estrogen and progesterone, tend to have mild courses of the disease. So something about being a woman is protective, and something about pregnancy is protective, and that makes us think about hormones, Dr. Ghandehari said.

Some experts who study sex differences in immunity, however, warned that hormones may fail to be the magic bullet that some are hoping for; even elderly women with Covid-19 are outliving their male peers, and there is a drastic reduction in levels of hormones for women after menopause.

The genesis of the estrogen trial at the Renaissance School of Medicine at Stony Brook University on Long Island stemmed from a similar observation, said Dr. Sharon Nachman, the trials principal investigator, who credited a Stony Brook surgeon, Dr. Antonios Gasparis, with the idea.

The trial enrolled its first patient this past week, and preliminary results could be available in a few months, she said.

Its totally out of the box, which is how good ideas often start, said Dr. Nachman, associate dean for research at the Renaissance School, which is part of the State University of New York.

The gender gap in coronavirus survival became apparent early in the pandemic. Reports from China indicated men were dying at higher rates, but the disparity was attributed to higher smoking rates. But the outcomes were consistent in other countries, with men in Italy dying at higher rates than women, and men in New York City dying at nearly double the rate of women.

Scientists who study sex differences say that both biological differences in immunity, as well as behavioral factors are at play. Men smoke more almost everywhere, they say; men also wash their hands less. While women appear to have more robust immune systems, these experts say, the causes are complex and multifactorial, and hormones are only part of the picture.

If such sex hormones were the primary protective factor for women, then elderly women with Covid-19 would fare as poorly as elderly men, because womens reproductive hormones plummet after menopause, said Sabra Klein, a scientist who studies sex differences in viral infections and vaccination responses at the Johns Hopkins Bloomberg School of Public Health.

But thats not the case, she said.

We see this bias across the life course, Dr. Klein said. Older men are still disproportionately affected, and that suggests to me its got to be something genetic, or something else, thats not just hormonal.

Estrogen has immune modulatory properties dont get me wrong, she continued. You could get a beneficial effect in both men and women. But if women are better at recovery at 93 years old, I doubt its hormones.

Research has shown estrogen may have an effect on a protein known as angiotensin-converting enzyme 2 (ACE2), for example. The coronavirus uses ACE2 receptors on the surfaces of cells as an entry route, and ACE2 is regulated differently in men and women, said Kathryn Sandberg, director of the Center for the Study of Sex Differences in Health, Aging and Disease at Georgetown University.

In studies with rats, Dr. Sandberg and her colleagues have shown that estrogen can reduce ACE2 protein expression in their kidneys, so it is possible the hormone may reduce ACE2 expression in men as well.

Dr. Nachman said, We may not understand exactly how estrogen works, but maybe we can see how the patient does, adding that estrogen plays a complex role, both in the early immune response that can help clear a viral infection, as well as in a secondary clean up or repair response, which can evolve into a cytokine storm.

While we see women do get infected, their responses are different, Dr. Nachman said. We see fewer of them having the second, disregulated immune response.

The Stony Brook estrogen trial is recruiting 110 patients who come to the hospitals emergency room with symptoms like fever, cough, shortness of breath or pneumonia, and who have either tested positive for Covid-19 or are presumed to have the illness, as long as they do not require intubation.

The trial is open to adult men as well as to women aged 55 and older, since they have low levels of estrogen. Half of the participants will be given an estradiol patch for one week, while the other half will serve as a control group, and researchers will follow them to see whether estrogen reduces the severity of their disease.

The Cedars-Sinai study is smaller, with only 40 subjects, all men, half of whom will be a control group. Only hospital inpatients with mild to moderate disease who have tested positive for Covid-19 can participate. (Patients with certain conditions, like a history of blood clots, are excluded for safety reasons.)

The patients will get two shots of progesterone a day for five days.

They will be monitored to see if their status is improving, how their needs for oxygen change and whether they go on to require intensive care or mechanical ventilation; their progress will be compared to patients in the control group.

The researchers in Los Angeles are pinning their hopes on progesterone rather than estrogen because research has shown that the hormone reduces pro-inflammatory immune cells, and supports those that fight inflammation, Dr. Ghandehari said. The hypothesis is that progesterone will prevent or dampen a harmful overreaction of the immune system, called a cytokine storm, and will reduce the likelihood of acute respiratory distress syndrome.

Both hormones are believed to be safe, especially when used for short durations. Participants will be warned of possible side effects that may be a first for many men, like tenderness in the breast and hot flashes.

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Can Estrogen and Other Sex Hormones Help Men Survive Covid-19? - The New York Times

Recommendation and review posted by Bethany Smith

WEDNESDAY, April 29, 2020 (HealthDay News) -- New research adds to a growing body of evidence that suggests men are far more vulnerable to severe COVID-19 than women are.

Although both genders fall ill in the same numbers, men are 2.5 times more likely to get severe disease and die, the study from China showed.

The finding comes as scientists in New York and California are starting to test a novel hypothesis that sex hormones might play a part in disease severity.

Last week, doctors on Long Island started treating COVID-19 patients with estrogen to boost their immune systems, The New York Times reported. And beginning next week, physicians in Los Angeles will start treating male patients with progesterone, a hormone that is predominantly found in women. Progesterone has anti-inflammatory properties and might prevent the immune system from overreacting, the researchers explained.

"There's a striking difference between the number of men and women in the intensive care unit, and men are clearly doing worse," Dr. Sara Ghandehari, a pulmonologist and intensive care physician at Cedars-Sinai in Los Angeles, told the Times. She is the principal investigator for the progesterone study.

But experts who study sex differences in immunity warned that hormones may not be the answer. Even elderly women with COVID-19 are outliving their male peers, despite drastic reductions in levels of hormones for women after menopause, they noted.

In the study from China, published April 29 in the journal Frontiers in Public Health, the differences between men and women showed up early in the coronavirus pandemic.

"Early in January, we noticed that the number of men dying from COVID-19 appeared to be higher than the number of women," explained researcher Dr. Jin-Kui Yang, a physician at Beijing Tongren Hospital.

"This raised a question: Are men more susceptible to getting or dying from COVID-19? We found that no one had measured gender differences in COVID-19 patients, and so began investigating," Yang said in a journal news release.

Included in the study were 43 patients treated by Yang's team, plus data on an additional 1,000 COVID-19 patients. The researchers also looked at the records of 524 SARS patients from 2003.

According to one large COVID-19 dataset, more than 70% of the patients who died were male, which meant that men had 2.5 times the death rate of women.

Being a man was also a risk factor for more severe illness, regardless of age.

Men who had SARS were also more likely to die, compared with women, Yang's team noted. Also, men had higher levels of the ACE2 protein involved in both sicknesses, which may be an explanation.

Although more research is needed, Yang recommended that "additional supportive care and prompt access to the intensive care unit may be necessary for older male patients."

More information

For more on COVID-19, see the U.S. Centers for Disease Control and Prevention.

SOURCES: Frontiers in Public Health, news release, April 29, 2020; The New York Times

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COVID-19 Continues to Strike Men Harder Than Women - HealthDay

Recommendation and review posted by Bethany Smith

Provided by SF Gate

By Deepak Chopra, MD, FACP, Rudolph E. Tanzi, PhD, Michelle Williams, ScD, Ryan Castle, William C. Bushell, PhD, Kimberly Brouwer, PhD, and Paul J. Mills, PhD

Although COVID-19 is very easily transmitted from person to person, the risk of subsequent hospitalization and death primarily affects people who are already at risk because of old age, infirmity and/or chronic diseases such as cancer, diabetes, autoimmune illness, obesity, and heart disease. All of these chronic illnesses are associated with measurable low-grade inflammation in the body. The chronic low-grade inflammation that develops with advanced age has become known as inflammaging. Most people with chronic illness unknowingly have low-grade inflammation. Recent research points to a second finding: these same disorders are often accompanied by persistent low-grade anxiety and depression.

All of this as a background increases the danger for a person when acute illness strikes. In addition to the elderly and chronically ill, COVID-19 is causing acute respiratory illness and stroke sometimes leading to death in seemingly otherwise healthy younger individuals. The transition from SARS-CoV-2 infection to diagnosed COVID-19 is typically accompanied by a cytokine storm. Cytokines are proteins that are major drivers of inflammation, and their rapid increase, or "storm is one of the bodys immune responses to acute threat.

In addition, studies have connected pro-inflammatory cytokines to the stress response; they regulate well-known stress hormones such as ACTH and cortisol. Three major systems are involved: the immune system, the central nervous system and the endocrine hormone system.

In the face of these connections, we are coming forward to suggest that complementary practicesdeep breathing, yoga, and meditationcan play an important role during this pandemic. These practices have been confirmed by hundreds of scientific studies to bring down over-activity of the autonomic nervous system, calm the mind from anxiety, reduce the stress response, regularize heartbeat, and lower blood pressure. Together, all of these diverse benefits are associated with reducing the invisible presence of chronic low-grade inflammation, especially if added to good sleep, exercise, and proper diet.

We dont fully understand how the immune response, linked to stress and inflammation, can turn lethal. As a response to cuts, wounds, invading pathogens, and other threats, prior to antibody formation, the body first responds with inflammation as a normal yet crucial healing function. But it has long been known that inflammation is paradoxical. Acute inflammation can over-react, harming or even killing the patient. (Instances of strokes and heart attacks among young COVID-19 patients might be linked to micro-cytokine storms in the brain and heart.)

The threat from low-grade chronic inflammation was not discovered until recently but seems to be widespread. It is unaccompanied by the swelling, burning, and redness of the skin that marks acute inflammation and therefore goes undetected by the patient or physician. Preventing and addressing chronic low-grade inflammation and its significant adverse consequences are urgent issues, even more urgent during a pandemic. There seems to be every reason to make the public aware how deep breathing, meditation, yoga, and other healthy lifestyle practices can help during this crisis and long afterwards.

Deepak Chopra MD, FACP, Clinical Professor of Family Medicine and Public Health at the University of California, San Diego

Rudolph E. Tanzi, PhD, Kennedy Professor of Neurology at Harvard Medical School/MGH

Michelle Williams, SM, ScD, Dean of the Faculty, Harvard T.H. Chan School of Public Health

Kimberly Brouwer, PhD, Professor and Chief, Department of Family Medicine and Public Health, Division of Global Health, Infectious Diseases Epidemiology, at the University of California, San Diego

Ryan Castle, Executive Director of the Chopra Library

William C. Bushell, PhD, medical anthropologist and research director of the Chopra Library

Paul J. Mills, PhD, Professor and Chief, Department of Family Medicine and Public Health, at the University of California, San Diego

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The Key to Handling Stress and COVID-19 - msnNOW

Recommendation and review posted by Bethany Smith

Campus News

The Chancellor Charles P. Norton Medal is UB's highest honor. Photo: Douglas Levere

UBNOW STAFF

Mary Wilson, wife of the late Buffalo Bills owner Ralph Wilson and a strong advocate of Western New York for the past 29 years, will be awarded the Chancellor Charles P. Norton Medal, UBs highest honor.

Jean Wactawski-Wende, SUNY Distinguished Professor of Epidemiology, dean of the School of Public Health and Health Professionals, and an internationally recognized researcher on womens health issues, will receive the UB Presidents Medal in recognition of extraordinary service to the university.

SUNY honorary doctorates are being presented to UB alumna Donnica L. Moore, president of the Sapphire Womens Health Group, and Richard A. Schatz, research director of cardiovascular interventions at the Scripps Heart, Lung and Vascular Center.

Wactawski-Wende will receive the Presidents Medal during the School of Public Health and Health Professions virtual commencement ceremony on May 16; the other award recipients will receive their honors at a later date.

The Chancellor Charles P. Norton Medal is presented annually in public recognition of a person who has, in Nortons words, performed some great thing which is identified with Buffalo a great civic or political act, a great book, a great work of art, a great scientific achievement or any other thing which, in itself, is truly great and ennobling, and which dignifies the performer and Buffalo in the eyes of the world.

Announcing this years Norton Medal recipient, Jeremy M. Jacobs, chair of the UB Council, said that Mary Wilson richly deserves the honor for her longstanding commitment to the region.

This year, we were absolutely unanimous in our decision to honor Mary Wilson, he said. In her leadership of the Wilson Foundation, Mary is making an enduring and unprecedented impact on Buffalo and all of Western New York, which will be felt for many generations to come. Her dedication and work align perfectly with the spirit of the Norton Medal.

Wilson has been devoted to Western New York since she first arrived in the area for the Bills home opener in 1990. She has spent many years developing her Western New York Girls in Sports program, which biannually brings more than 200 9- to 12-year-old girls together to take part in various sports taught by young athletes from local universities and sports clubs. The program, now ensured to run in perpetuity, is organized by the United Way of Buffalo and Erie County through an endowment from the Ralph C. Wilson Jr. Foundation, of which Wilson serves as one of four life trustees.

She has also supported organizations benefiting communities in Buffalo, Erie County and Southeast Michigan, among them Hospice of Western New York, WNY Womens Foundation, Food Bank of Western New York, Albright-Knox Art Gallery, Girl Scouts of Western New York, the SPCA serving Erie County, the Buffalo Philharmonic Orchestra, the Alzheimers Association Greater Michigan Chapter, The Helm (formerly Services for Older Citizens), the Detroit Symphony Orchestra, the Detroit Historical Society and the Detroit Institute of Arts, to name a few.

The UB Presidents Medal, first presented in 1990, recognizes outstanding scholarly or artistic achievements, humanitarian acts, contributions of time or treasure, exemplary leadership or any other major contribution to the development of the University at Buffalo and the quality of life in the UB community.

President Satish K. Tripathi described recipient Jean Wactawski-Wende as a world-renowned epidemiologist who has brought great prominence to UB through her scholarly pursuits and academic excellence in the area of womens health.

A dedicated member of our university community for more than 30 years, Dr. Wactawski-Wende has made seminal contributions that have significantly impacted health care practice and disease prevention for women in the U.S. and around the world, he said.

Thanks to her tremendous leadership, she has further elevated the reputation of UB. Our university community, along with the many communities we serve, have been profoundly enriched by Dr. Wactawski-Wendes scholarship, teaching and service, and it is an honor to present the Presidents Medal to such a truly deserving recipient.

Of particular note is Wactawski-Wendes leadership role in the Womens Health Initiative (WHI), the largest longitudinal study of womens health in the United States. In 1993, she was part of the team that spearheaded UBs successful bid to become one of the federally funded studys 16 original vanguard clinical centers. Since the inception of the WHI, UB has received more than $30 million in funding from the National Institutes of Health to investigate health issues impacting postmenopausal women.

Among the WHIs major discoveries was the groundbreaking finding that intake of combined estrogen plus progestin was associated with an increased risk of heart disease, stroke and invasive breast cancer. That research, on which Wactawski-Wende served as a co-principal investigator, changed the use of hormone therapy in older women worldwide, potentially saving countless lives.

Through UBs current $6.2 million award extension of the WHI, she has overseen the continuation of research into many diseases associated with aging, such as cardiovascular disease, cancer, osteoporosis, stroke and dementia. She is also administering new studies that focus on frailty and predictors of healthy aging.

For those of us who know and have worked closely with Dr. Wactawski-Wende, we readily recognize the magnitude and excellence of her contributions to academic medicine, said Michael E. Cain, vice president for health sciences and dean of the Jacobs School of Medicine and Biomedical Sciences at UB. She is an eminent and distinguished scholar and leader whose work, professional service, and stature in her discipline and research field are outstanding and continue to grow.

An internationally recognized womens health expert and advocate, Donnica L. Moore is president of Sapphire Womens Health Group, a multimedia firm that educates women about the benefits of a healthy lifestyle. A pioneering physician, Moore utilizes public speaking and multiple media platforms including her own website and podcast to share impactful health information in laypersons terms.

She will receive a SUNY Honorary Doctorate in Science.

Dr. Moores significant accomplishments associated with women's health set an inspiring example for our university community and reflect the values of both UB and the SUNY system, Tripathi said.

Breaking barriers to educate women about an array of health-related topics, she has demonstrated a sustained and dedicated commitment to the well-being of women around the globe. One of UBs most distinguished alumni, Dr. Moore in utilizing accessible platforms to create broad access to sound, peer-reviewed medical information is enhancing lives in communities near and far.

A 1986 alumna of the Jacobs School of Medicine and Biomedical Sciences, Moore underwent residency training in obstetrics and gynecology at Temple University, followed by a year of family medicine training at Memorial Hospital of Burlington, New Jersey. The editor-in-chief of Womens Health for Life, she has served on the editorial boards of the Journal of Women's Health and the Journal of the American Medical Womens Association, in addition to the board of directors of the Society for Womens Health Research, among other organizations.

Known for her relatable delivery and depth of expertise, Moore was the womens health contributor for NBCs Later Today and has appeared more than 800 times on such programs as The Oprah Winfrey Show, The Anderson Cooper Show and Good Morning America. Additionally, she has been a medical adviser or medical advisory board member for companies including DuPont and Helm Pharmaceuticals.

Richard A. Schatz is co-creator of the first coronary stent approved by the Food and Drug Administration for restenosis. Known as the Palmaz-Schatz stent, this life-saving device has been used to treat coronary artery disease in nearly 100 million patients worldwide since its approval in 1994. It is considered one of the top 10 medical device patents of the past 50 years.

He will receive a SUNY Honorary Doctorate in Science.

Dr. Schatz is widely known as the father of modern interventional cardiology for good reason, Tripathi said. Every day, his groundbreaking work is realized in operating rooms across the country and beyond. The stent he co-created spurred a revolution in the treatment of coronary artery disease and, 30 years later, it has had an immeasurable impact on health care.

By contributing to society through his biomedical innovations and inventions, Dr. Schatz has improved the lives of tens of millions of people while embodying the ideals of our university community and our university system.

A New York native, Schatz is the research director of cardiovascular interventions at the Scripps Clinic and director of gene and stem cell therapy. He is an elected fellow of the American College of Cardiology; in 2019, he received the Fritz J. And Dolores H. Russ Prize, which recognizes biomedical engineering achievements that have significantly improved the human condition. He is also the recipient of the Barton Haynes Lifetime Scholar Award from Duke University Medical Center.

Schatz attended UB in the early 1970s before gaining early admission to Duke Medical School, then completed his cardiology training at Brooke Army Medical Center. Throughout his career, he has maintained a strong affinity for UB, crediting the universitys faculty and curriculum for inspiring him to pursue a career in medicine.

Read more:
Wilson to receive Norton Medal - UB Now: News and views for UB faculty and staff - University at Buffalo Reporter

Recommendation and review posted by Bethany Smith

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May 1, 2020

Find out more about the coronavirus pandemic.

By Dr. Jenifer Maynard

WHAT IS CORONAVIRUS and WHAT IS A PANDEMIC?

COVID-19 PRIMARILY SPREADS FROM PERSON TO PERSON AND FROM CONTAMINATED OBJECTS AND SURFACES

SYMPTOM RECOGNITION

DIAGNOSIS

TREATMENT

REDUCE YOUR RISK OF COVID-19! FOLLOW THESE GUIDELINES

THE IMMUNE SYSTEM

The immune system is complex, is composed of special organs, cells, and chemicals that prevent, limit and fight infection. The main components of the immune system include white blood cells, antibodies, the complement system, the lymphatic system, the spleen, the thymus, and bone marrow. Keep your immune system fighting fit with a comprehensive approach to all aspects of your health: physical, mental, emotional, and spiritual.

1. Dont smokea. Smoking decreases circulation and negatively affects lung function. Smoking is linked to many diseases, such as cancer, coronary artery disease, strokes, emphysema and other lung diseases. All of these reduce immune function.

2. Avoid excessive alcohola. Alcohol reduces immune system function by negatively affecting the digestive system, circulatory system, respiratory system, and decreases the production of immune cells.

3. Get adequate sleepa. Inadequate sleep may increase your risk of illness, including diabetes, obesity and heart disease. Most adults should aim for a minimum of 7 hours of sleep per night.

4. Minimize stressa. Cortisol is the hormone released during periods of high stress; it is known to suppress the immune system.b. To moderate your stress response, use relaxation techniques that are most effective for you - these can include yoga, meditation, prayer, listening to music, reading, walking, talking with a friend.c. Laughter is a great form of stress relief. It enhances oxygen uptake stimulating the heart and lungs and increases endorphins, thereby soothing tension and reducing stress.

5. Eat a diet high in fruits and vegetablesa. Recommended daily servings of fruit = 2+ (1 serve = 1 raw fruit, 1 cup of berries, or 1 cup of juice)b. Recommended daily servings of vegetables = 5+ (1 serve = 1 cup raw or cup cooked vegetables)c. Whole plant foods contain antioxidants, a substance that protects cells against the potentially damaging effects of free radicals. Antioxidant rich foods include blueberries, pecans, dark chocolate, strawberries, artichokes, goji berries, raspberries, kale, red cabbage, beans, beets, and spinach.

6. Encourage healthy gut floraa. 70% of our immune system is located within the gut. To encourage good gut bacteria, eat plenty of fibrous foods and pre-biotic foods such as, bananas, chicory, and flax seeds.b. Fruits and vegetables are excellent sources of fiber, helping to reduce constipation and improve gut microbiome.

7. Eat healthy fatsa. Healthy fats, like those found in avocados, olive oil, or salmon, may boost the bodys immune response to pathogens (bacteria and viruses) by decreasing inflammation.

8. Consume sugar sparinglya. Sugar significantly reduces the ability of white blood cells to destroy pathogens.

9. Exercise regularlya. Moderate exercise improves the immune system by stimulating the lymphatic system. The lymphatic system houses immune cells that kill off abnormal cells and harmful substances. Muscle contractions during exercise works as the pump for the lymphatic system, so that it flows more effectively and potentially prevents infections.b. Intense bursts of exercise and prolonged training should be avoided when you feel unwell as this can depress the immune system - reduce training if presenting with excessive fatigue.

10. Proper hygienea. Wash your hands regularly, the Center for Disease Control (CDC) recommends lathering with soap and scrubbing for 20 seconds.b. When you dont have access to soap and water, use an alcohol-based hand sanitizer (>60% alcohol)c. Decontaminate frequently touched surfaces by wiping down with disinfectant.

The contents of the Health site are for informational purposes only and should not be treated as medical, psychiatric, psychological, health care or health management advice. The materials herein are not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this site. Reliance on any information provided herein is solely at your own risk.

A special thanks to the author, Dr Jenifer Maynard, WTA Medical Advisor.

Original post:
Physically Speaking: The facts about COVID-19 - WTA Tennis

Recommendation and review posted by Bethany Smith

During the rare moments youve ventured outside these days, youve probably noticed clearer skies and the benefits of reductions in air pollution.

Long-term exposure to air pollution increases the danger associated with four of the biggest Covid-19 mortality risks: diabetes, hypertension, coronary artery disease and asthma. It also can make the immune system overreact, exaggerating the inflammatory response to common pathogens.

But there are other common contaminants in our homes that are also likely to be hacking our immune systems, which have had less attention.

Youve probably heard about synthetic chemicals in non-stick pans, cosmetics and aluminum cans disrupting our hormones. The notion of endocrine-disrupting chemicals was only widely accepted about a decade ago, when scientific societies raised the alarm. The science of immune disruption is even newer, with a large review in a major scientific journal just out last year.

You may have heard of forever chemicals, or perfluoroalkylsubstances (PFAS) from the movie Dark Waters, with Mark Ruffalo. These chemicals, used to keep food from sticking to surfaces and our clothing free of oily stains, are widely found in the US water supply. Were talking about chemicals that 110 million Americans drink each day that increase the death rate of mice exposed to influenza type A. Children exposed during pregnancy have worse immune responses to vaccines, with weaker antibody responses. Studies in Norway, Sweden and Japan have found greater difficulties in children with various infections, ranging from colds to stomach bugs to ear infections.

Bisphenol A, or BPA, which is found in thermal paper receipts and aluminum can linings, has been found in the laboratory to increase the bodys release of a molecule called interleukin-6, or IL-6, that may be involved in the raging wildfire inside the lung that has already killed so many from coronaviruses. One of the more promising treatments for coronavirus patients is tocilizumab, an antibody to IL-6. Phthalates, used in cosmetics, personal care products and food packaging, alter levels of cytokines, which are key players in the immune response to coronavirus.

Is the evidence perfect? Hardly. And we have to rely on observational studies you cant run a randomized controlled trial of potentially toxic mixtures of virus and chemical exposures. There are ethical and logistical challenges to running these kinds of studies. But absence of evidence doesnt mean absence of harm.

Will preventing these exposures now change exposure to the novel coronavirus? No. Stay home, wash your hands with soap and water at least 30 seconds at a time, and keep your social distancing game strong. Right now, we need to keep as calm as we can and carry on as best we can. Weve overcome other disasters 9/11, Katrina and Sandy, to name just a few. And once we return to normal, we can limit these exposures in our daily lives using cast iron and stainless steel instead of nonstick pans, avoiding canned food consumption, and reducing the use of plastic in our lives.

But when we return to normal, we have to ask ourselves how and why we got here, just like we did for those disasters. West Nile, Zika, dengue, Ebola and other infections are on the rise, and they are attacking us when our immune defenses are being attacked by preventable contaminants in the environment. Government and industry have dragged their feet time and again to limit these exposures because of intense economic pressure. Youve probably heard that the US Environmental Protection Agency (EPA) has used the coronavirus pandemic to waive its enforcement rules, allowing companies to pollute without consequences.

But its not just at the EPA where science has undermined human health over chemicals that can affect the immune system. The Food and Drug Administration (FDA) has failed to protect kids from known hazards in food packaging and other contact surfaces, allowing industry to vouch for safety without careful study of potential adverse effects. And when negative effects are found, the FDA is limited in its ability to require companies to stop using toxic ingredients in its materials.

Infections are not just something we vaccinate away or treat. New infections will emerge even more in the future if we dont appreciate the consequences of messing with Mother Nature and realize our immune systems are being hacked, too.

Leonardo Trasande is Jim G Hendrick MD professor of pediatrics at NYU Grossman school of medicine, and the author of Sicker, Fatter, Poorer, which describes the effects of endocrine-disrupting chemicals on human health and the economy and what we can do about it. Akhgar Ghassabian is a physician-epidemiologist in the department of pediatrics at NYU Grossman, where she studies the effects of synthetic chemicals on immune function and childrens health

More:
The toxic chemicals in our homes could increase Covid-19 threat - The Guardian

Recommendation and review posted by Bethany Smith

After Rehema was pressured to abort and began a chemical abortion, she reached out and received help from the Abortion Pill Rescue Network in Nairobi, Kenya, and was able to save her unborn son through Abortion Pill Reversal (APR).

Taken by her mother to no less than three abortion facilities, having witnessed the callousness toward life present in the abortion industry, and facing losing a place to live because of her conviction to try to save her unborn son, she is thankful for his life and hopeful for the future.

God has a purpose for my life in this boy, she said. So definitely He will make a way.

And trust me, Rehema stated. (Chemical) abortion can be reversed. I am a living testimony.

Tweet This: And trust me, (chemical) abortion can be reversed. I am a living testimony.

Rehema also said it was God who brought her to Heartbeat Internationals Abortion Pill Rescue Network (APRN). She acted quickly, the reversal has been successful, and she wanted to share her experience.

[Click here to subscribe to Pregnancy Help News!]

Hers is the latest story of a woman falsely made to feel like she had no other choice but to abort.

It is also the story of yet another life saved through the APRN, which consists of more than 600 health care professionals prepared to administer an FDA-approved drug that has successfully stopped abortions after a mother requests intervention. Along with the 600-plus health care practitioners, some 300 pregnancy help organizations in the APRN network also assist women who choose to try and save their baby by initiating the Abortion Pill Reversal (APR) process.

The abortion pill, also known as medication abortion, chemical abortion, RU-486 or self-managed abortion, refers to the drugs mifepristone and misoprostol, taken to abortion a child within the first 10 weeks of a pregnancy.

That first pill, mifepristone, blocks the effects of progesterone the natural hormone that women produce which provides the essential nutrients needed for their developing baby to thrive. The second drug in the chemical abortion process, misoprostol, is taken 6-48 hours later, typically at home, causing cramping and bleeding associated with emptying the mothers uterus, when she then delivers her deceased child.

A chemical abortion can be reversed after taking mifepristone and before misoprostol.

APR works by giving the mother extra progesterone up to 72 hours after she takes the first chemical abortion drug. The treatment has the best chance for success when started within 24 hours. APR is a new application of an FDA-approved progesterone treatment used beginning in the 1950s to stop miscarriages. To date, more than 900 lives have been saved through APR.

The APRN continues to expand internationally, and the month of March saw a record number of moms beginning the abortion pill reversal process through the Network.

Rehema shared her story with Heartbeat National after confirming that her unborn son was healthy following initiation of the APR regimen.

She had gotten a call from her mother on April 21, telling her she would be taking her for an abortion, the reason being that Rehema and the babys father are of different faiths.

They went to a Marie Stopes abortion facility where after an ultrasound Rehema was told she 22 weeks and 4 days pregnant. With their standard cut-off for conducting abortions at 20 weeks, Rehema said the facility declined to do the procedure.

But her mother didnt relax, she said, taking her to another local Marie Stopes location, where they also declined to conduct the abortion.

Rehemas mother took her to another abortionist who regardless of her childs gestational age agreed to perform the abortion.

Asking the abortionist what would happen if her baby survived the procedure and was born - and crying - she said he indicated in no uncertain terms that he knows how tosilencesuch children, which disturbed her.

I got goosebumps all over, she said. I told him to give me time to think.

Rehema said she went home, but her mother was just too persistent, kept mocking her, and so on April 25 she decided to visit one of the abortion contacts her mother had found.

And they gave me mifepristone and told me to swallow it immediately, Rehema said, immediately sorry for the decision.

I was desperate, she continued. I didnt know who to talk to on the night of the 25th I cried a lot.

I was feeling guilty, she said. How could I kill my innocent little one? I just saw how healthy he was during the ultrasound

I was losing it, Rehema told Heartbeat International. Then I decided to go through Google

God directed me to APR, said Rehema. And I sent an email.

Tweet This: God directed me to Abortion Pill Reversal

In no time I got a How may I help you? she recounted.

Rehema talked to several APRN consultants, whom she said have been calling, texting and emailing her, as well as checking in with her over social media.

May God bless you all, she said of the consultants.

Rehema was connected with a doctor in the APRN who began the APR protocol.

This one is just an angel in human flesh, she stated of the physician.

The doctors office worked with her financially on treatment, she said, even though she did not have much money, and everyone at the clinic where she has been receiving treatment has been friendly.

I am assured everything is fine, no complications at all, Rehema told Heartbeat.

And guess what guys ware having a healthy baby boy!!

Isnt our God a wonderful God she exclaimed. Isnt He the most merciful and most forgiving?

Rehema then came home and found her mother waiting.

She said her mother told her that since she didnt want to abort, that she should know she is in this alone, and to leave her place.

Despite this Rehema has remained hopeful and happy to have her son.

She said she just wants to have a new start.

I have seen the worst, but I conquered, Rehema told Heartbeat. Much love and God Bless!!

Tweet This: I have seen the worst, but I conquered. Much love and God Bless!! Mom whose baby was saved with APR

The APRNs consultants remain in contact with Rehema. Pregnancy Help News and Heartbeat International will monitor her situation and publish updates when possible.

Editors note: Heartbeat International manages the Abortion Pill Rescue Network and Pregnancy Help News.

Read the original:
I have seen the worst, but I conquered - mom pressured to abort looks forward with hope after baby saved with APR - Pregnancy Help News

Recommendation and review posted by Bethany Smith

TEL AVIV, Israel & PARSIPPANY, N.J. & INCHEON, South Korea--(BUSINESS WIRE)-- Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Celltrion Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that TRUXIMA (rituximab-abbs) injection is now available in the United States for the treatment of:

TRUXIMA is the only biosimilar to the reference product Rituxan1 (rituximab) available to treat rheumatoid arthritis in the United States. See important safety information below including Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

We are proud to make TRUXIMA available to patients and providers as a treatment option for these indications, especially as this is the only rituximab biosimilar indicated for rheumatoid arthritis, said Brendan OGrady, Executive Vice President, North America Commercial, Teva. Following the launch of our other biosimilar earlier this year, we remain focused on our commitment to lower healthcare costs and increase price competition through the availability of biosimilars.

Celltrion Healthcare and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 for Teva to commercialize TRUXIMA in the U.S. and Canada. In May 2019, TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) to match all of the reference products oncology indications described below.

We are pleased that patients in the United States can now have access to TRUXIMA for these new indications, said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We believe that the continued use of biosimilars in the U.S. market will contribute to addressing unmet needs for patients and providers.

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) granted pass-through status for TRUXIMA in the hospital outpatient setting. The Wholesale Acquisition Cost (WAC or list price) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is expected to be available through primary wholesalers at a WAC of $845.55 per 100mg vial and $4,227.75 per 500mg vial. Actual costs to individual patients and providers for TRUXIMA are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patients insurance payer and eligibility for participation in the assistance program.

Teva also offers dedicated patient support services through the CORE program. CORE is available to help eligible patients, caregivers and healthcare professionals navigate the reimbursement process. CORE offers a range of services, including benefits verification and coverage determination, support for precertification and prior authorization, assistance with coverage guidelines and claims investigation, and support through the claims and appeals process. A savings program is also available for eligible commercially insured patients. To learn more, please visit TevaCORE.com.

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. For more information, please see the full prescribing information.

Indications TRUXIMA (rituximab-abbs) is indicated for the treatment of adult patients with:

Non-Hodgkins Lymphoma (NHL)

Chronic Lymphocytic Leukemia (CLL)

Rheumatoid Arthritis (RA)

Granulomatosis with Polyangiitis (GPA) (Wegeners Granulomatosis) and Microscopic Polyangiitis (MPA)

Important Safety Information

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions: Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products

Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products

WARNINGS AND PRECAUTIONS

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death

Premedicate patients with an antihistamine and acetaminophen prior to dosing. For RA, GPA, and MPA patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (25,000/mm3)

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive)

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells ( 25,000/mm3) or high tumor burden, confers a greater risk of TLS

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment

Prior to initiating TRUXIMA physicians should ensure patients vaccinations and immunizations are up-to-date with guidelines. Administration of any non-live vaccines should occur at least 4 weeks prior to a course of TRUXIMA

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA

Concomitant Use With Other Biologic Agents and DMARDS Other Than Methotrexate

Observe patients closely for signs of infection if biologic agents and/or DMARDs are used concomitantly as limited safety data is available.

Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with rituximab products

Use in RA Patients Who Have Not Had Prior Inadequate Response to TNF Antagonists

TRUXIMA should only be used in patients who have had a prior inadequate response to one or more TNF antagonist

Most common adverse reactions in clinical trials of NHL (25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia

Most common adverse reactions in clinical trials of CLL (25%) were: infusion-related reactions and neutropenia

Most common adverse reactions in clinical trials of RA (10%) were: upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events)

Most common adverse reactions in clinical trials of GPA and MPA (15%) were: infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, and infusion-related reactions

Nursing Mothers - There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants

About TRUXIMA TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration (FDA)-approved biosimilar to RITUXAN (rituximab) for the treatment of: adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC); for rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies; and granulomatosis with polyangiitis (GPA) (Wegeners Granulomatosis) and microscopic polyangiitis (MPA) in adult patients in combination with glucocorticoids

TRUXIMA has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan through a totality of evidence.

About Celltrion Healthcare, Co. Ltd. Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcares products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.

About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.

Teva's Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of TRUXIMA Injection for Rheumatoid Arthritis in the United States, which are based on managements current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors and Forward Looking Statements. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1 RITUXAN is a registered trademark of Genentech and Biogen.

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Teva and Celltrion Healthcare Announce the Launch of TRUXIMA (rituximab-abbs) Injection for Rheumatoid Arthritis, the Only Biosimilar to Rituxan...

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