Topline Data for HST-001 Phase 1b/2a Trial for Androgenic Alopecia in Men on Track for 4Q20

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Histogen Reports Third Quarter 2020 Earnings and Provides Business Update

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NEWTON, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2020, and provided an update on the Company’s recent corporate developments.

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Acer Therapeutics Reports Third Quarter 2020 Financial Results and Provides Corporate Update

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GUILFORD, Conn., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BIOASIS TECHNOLOGIES INC–Bioasis Technologies Inc. (TSX.V:BTI; OTCQB:BIOAF) (the “Company” or “Bioasis”), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3™ platform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and the treatment of central nervous system (“CNS”) disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, today announces details of its forthcoming Annual General Meeting (“the Meeting”) of shareholders. The Meeting will be held at the offices of Marcum LLP, 555 Long Wharf Dr. 8th floor, New Haven, CT 06511, USA, on Thursday December 10, 2020 at 9:00 a.m. (Eastern standard time).

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Bioasis Announces Annual General Meeting Details

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TEMPLE CITY, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the “company”), a technology company providing comprehensive testing solutions through its scalable technology platform, today announced that its Chief Financial Officer Paul Kim and Chief Commercial Officer Brandon Perthuis are scheduled to virtually participate in the Credit Suisse 29th Annual Virtual Healthcare Conference on Wednesday, November 11, 2020. These representatives of the company will host a presentation beginning at 3:30 p.m. ET.

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Fulgent Genetics to Participate in the Credit Suisse 29th Annual Virtual Healthcare Conference

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- Initiation of Phase 1/2a Trial of CLS-AX (axitinib injectable suspension) for Wet Age-Related Macular Degeneration Expected by Year-End 2020 -- Phase 2 Trials Using SCS Microinjector® Ongoing by Gene Therapy and Oncology Partners -- Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

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Clearside Biomedical Announces Third Quarter 2020 Financial Results and Provides Corporate Update

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PLEASANTON, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- 10x Genomics, Inc. (Nasdaq: TXG) today reported financial results for the third quarter ended September 30, 2020.

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10x Genomics Reports Third Quarter 2020 Financial Results

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Company to host conference call and webcast today, November 10, at 4:30pm ET Company to host conference call and webcast today, November 10, at 4:30pm ET

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Eyenovia Reports Third Quarter 2020 Financial Results

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SEATTLE, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (“Adaptive Biotechnologies”) (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today reported financial results for the quarter ended September 30, 2020.

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Adaptive Biotechnologies Reports Third Quarter 2020 Financial Results

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SEATTLE, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced a collaboration with GlaxoSmithKline plc (GSK) to use its clonoSEQ® Assay to assess minimal residual disease (MRD) in GSK’s portfolio of hematology products.

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Adaptive Biotechnologies Announces Collaboration with GSK to Measure Minimal Residual Disease with clonoSEQ® Assay Across its Hematology and Oncology...

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Company to host investor conference call and webcast today at 5:00 pm EST Company to host investor conference call and webcast today at 5:00 pm EST

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Viela Bio Reports Third Quarter 2020 Financial Results and Program Highlights

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BOULDER, Colo., Nov. 10, 2020 (GLOBE NEWSWIRE) -- miRagen Therapeutics, Inc. (NASDAQ: MGEN), a biotechnology company advancing new treatments for patients with diseases that are underserved by current therapies, today announced financial results for the third quarter ended September 30, 2020 and provided corporate updates.

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miRagen Reports Third Quarter 2020 Financial Results and Provides Corporate Updates

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LEXINGTON, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, today provided a business update and reported financial results for the third quarter of 2020.

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Keros Therapeutics Reports Recent Business Highlights and Third Quarter 2020 Financial Results

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BRIDGEWATER, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Clinical Genomics (“CG” or the “Company”), a provider of colorectal cancer diagnostic solutions, including liquid biopsy tests, today announced that Betsy Hanna, Chief Executive Officer, will present at the 2020 Canaccord Genuity Virtual Medical Technologies & Diagnostics Forum as follows:

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Clinical Genomics to Present at 2020 Canaccord Genuity Virtual Medical Technologies & Diagnostics Forum

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EWING, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“the Company”), a pharmaceutical technology company, today announced that Robert F. Apple, President and Chief Executive Officer is scheduled to present at the Jefferies Virtual London Healthcare Conference.

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Antares Pharma to Present at the Jefferies Virtual London Healthcare Conference

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SAN DIEGO, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that President and CEO Athena Countouriotis, M.D., will present a company overview at the Jefferies Virtual London Healthcare Conference on Nov. 18.

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Turning Point Therapeutics to Participate in Jefferies Virtual London Healthcare Conference

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FOSTER CITY, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Vaxcyte, Inc., formerly known as SutroVax, a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide, today announced that company management will present at the Jefferies Virtual London Healthcare Conference on Tuesday November 17, 2020 at 12:35pm ET.

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Vaxcyte to Present at Jefferies Virtual London Healthcare Conference

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TORONTO, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Golden Leaf Holdings Ltd. (“Golden Leaf” or the “Company”) (CSE:GLH) (OTCQB:GLDFF), a premier consumer-driven cannabis company specializing in production, processing, wholesale, distribution and retail, will announce its financial results for the third quarter ended September 30, 2020, on Thursday, November 19, 2020 after market close. All figures in USD unless otherwise noted.

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Golden Leaf Holdings to Report Third Quarter Earnings

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Market Report Summary

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Spinal Cord Trauma Treatment Market: Global Industry Analysis 2012 2016 and Forecast 2017 2025is the recent report of Persistence Market Research that throws light on the overall market scenario during the period of eight years, i.e. 2017-2025. According to this report, Globalspinal cord trauma treatment marketis expected to witness significant growth during the forecast period.

This growth is expected to be primarily driven by increasing incidence of spinal cord trauma, and increasing government support to reduce the burden of spinal cord injuries. Additionally, development of nerve cells growth therapy is expected to boost the market in near future.

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The global market for spinal cord trauma treatment is is estimated to be valued at US$ 2,276.3 Mn in terms of value by the end of 2017. The global spinal cord trauma treatment market is expected to expand at a CAGR of 3.7% over the forecast period to reach a value of US$ 3,036.2 Mn by 2025end.

Global Spinal Cord Trauma Treatment Market: Trends

Global Spinal Cord Trauma Treatment Market: Forecast by End User

On the basis of end user, the global spinal cord trauma treatment market is segmented into hospitals and trauma centers. Hospitals segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period.

Hospitals and trauma centers segments are expected to approximately similar attractive index. Hospitals segment accounted for 53.2% value share in 2017 and is projected to account for 52.5% share by 2025 end.

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Global Spinal Cord Trauma Treatment Market: Forecast by Injury Type

On the basis of injury type, the global spinal cord trauma treatment market is segmented into complete spinal cord injuries and partial spinal cord injuries.

Partial spinal cord trauma treatment segment is expected to show better growth than the completed spinal cord treatment segment due to higher growth in the incidence rate of partial spinal cord trauma than the complete spinal cord trauma. With US$ 1,870.3 Mn market value in 2025, this segment is likely to expand at CAGR 3.8% throughout the projected period.

Global Spinal Cord Trauma Treatment Market: Forecast by Treatment Type

On the basis of treatment type, the global spinal cord trauma treatment market is segmented into corticosteroid, surgery, and spinal traction segments.

Surgery segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period. Surgery segment is the most attractive segment, with attractiveness index of 2.6 over the forecast period.

Global Spinal Cord Trauma Treatment Market: Forecast by Region

This market is segmented into five regions such as North America, Latin America, Europe, APAC and MEA. Asia-Pacific account for the largest market share in the global spinal cord trauma treatment market.

Large patient population due to the high rate of road accidents and crime is making the Asia Pacific region most attractive market for spinal cord trauma treatment. On the other hand, MEA and Latin America is expected to be the least attractive market for spinal cord trauma treatment, with attractiveness index of 0.3 and 0.5 respectively over the forecast period.

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Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance.

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Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

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The Spinal Cord Trauma Treatment Market To Witness A Substantial Demand Amidst Covid-19, To Reach US$ 3000 Mn - The Think Curiouser

Spinal Cord Stem Cells Comments Off on The Spinal Cord Trauma Treatment Market To Witness A Substantial Demand Amidst Covid-19, To Reach US$ 3000 Mn – The Think Curiouser | November 10th, 2020

ANDOVER, Mass. The liquid that many hope could help end the Covid-19 pandemic is stored in a nondescript metal tank in a manufacturing complex owned by Pfizer, one of the worlds biggest drug companies. There is nothing remarkable about the container, which could fit in a walk-in closet, except that its contents could end up in the worlds first authorized Covid-19 vaccine.

Pfizer, a 171-year-old Fortune 500 powerhouse, has made a billion-dollar bet on that dream. So has a brash, young rival just 23 miles away in Cambridge, Mass. Moderna, a 10-year-old biotech company with billions in market valuation but no approved products, is racing forward with a vaccine of its own. Its new sprawling drug-making facility nearby is hiring workers at a fast clip in the hopes of making history and a lot of money.

In many ways, the companies and their leaders couldnt be more different. Pfizer, working with a little-known German biotech called BioNTech, has taken pains for much of the year to manage expectations. Moderna has made nearly as much news for its stream of upbeat press releases, executives stock sales, and spectacular rounds of funding as for its science.

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Each is well-aware of the other in the race to be first.

But what the companies share may be bigger than their differences: Both are banking on a genetic technology that has long held huge promise but has so far run into biological roadblocks. It is called synthetic messenger RNA, an ingenious variation on the natural substance that directs protein production in cells throughout the body. Its prospects have swung billions of dollars on the stock market, made and imperiled scientific careers, and fueled hopes that it could be a breakthrough that allows society to return to normalcy after months living in fear.

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Both companies have been frequently name-checked by President Trump. Pfizer reported strong, but preliminary, data on Monday, and Moderna is expected to follow suit soon with a glimpse of its data. Both firms hope these preliminary results will allow an emergency deployment of their vaccines millions of doses likely targeted to frontline medical workers and others most at risk of Covid-19.

There are about a dozen experimental vaccines in late-stage clinical trials globally, but the ones being tested by Pfizer and Moderna are the only two that rely on messenger RNA.

For decades, scientists have dreamed about the seemingly endless possibilities of custom-made messenger RNA, or mRNA.

Researchers understood its role as a recipe book for the bodys trillions of cells, but their efforts to expand the menu have come in fits and starts. The concept: By making precise tweaks to synthetic mRNA and injecting people with it, any cell in the body could be transformed into an on-demand drug factory.

But turning scientific promise into medical reality has been more difficult than many assumed. Although relatively easy and quick to produce compared to traditional vaccine-making, no mRNA vaccine or drug has ever won approval.

Even now, as Moderna and Pfizer test their vaccines on roughly 74,000 volunteers in pivotal vaccine studies, many experts question whether the technology is ready for prime time.

I worry about innovation at the expense of practicality, Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and an authority on vaccines, said recently. The U.S. governments Operation Warp Speed program, which has underwritten the development of Modernas vaccine and pledged to buy Pfizers vaccine if it works, is weighted toward technology platforms that have never made it to licensure before.

Whether mRNA vaccines succeed or not, their path from a gleam in a scientists eye to the brink of government approval has been a tale of personal perseverance, eureka moments in the lab, soaring expectations and an unprecedented flow of cash into the biotech industry.

It is a story that began three decades ago, with a little-known scientist who refused to quit.

Before messenger RNA was a multibillion-dollar idea, it was a scientific backwater. And for the Hungarian-born scientist behind a key mRNA discovery, it was a career dead-end.

Katalin Karik spent the 1990s collecting rejections. Her work, attempting to harness the power of mRNA to fight disease, was too far-fetched for government grants, corporate funding, and even support from her own colleagues.

It all made sense on paper. In the natural world, the body relies on millions of tiny proteins to keep itself alive and healthy, and it uses mRNA to tell cells which proteins to make. If you could design your own mRNA, you could, in theory, hijack that process and create any protein you might desire antibodies to vaccinate against infection, enzymes to reverse a rare disease, or growth agents to mend damaged heart tissue.

In 1990, researchers at the University of Wisconsin managed to make it work in mice. Karik wanted to go further.

The problem, she knew, was that synthetic RNA was notoriously vulnerable to the bodys natural defenses, meaning it would likely be destroyed before reaching its target cells. And, worse, the resulting biological havoc might stir up an immune response that could make the therapy a health risk for some patients.

It was a real obstacle, and still may be, but Karik was convinced it was one she could work around. Few shared her confidence.

Every night I was working: grant, grant, grant, Karik remembered, referring to her efforts to obtain funding. And it came back always no, no, no.

By 1995, after six years on the faculty at the University of Pennsylvania, Karik got demoted. She had been on the path to full professorship, but with no money coming in to support her work on mRNA, her bosses saw no point in pressing on.

She was back to the lower rungs of the scientific academy.

Usually, at that point, people just say goodbye and leave because its so horrible, Karik said.

Theres no opportune time for demotion, but 1995 had already been uncommonly difficult. Karik had recently endured a cancer scare, and her husband was stuck in Hungary sorting out a visa issue. Now the work to which shed devoted countless hours was slipping through her fingers.

I thought of going somewhere else, or doing something else, Karik said. I also thought maybe Im not good enough, not smart enough. I tried to imagine: Everything is here, and I just have to do better experiments.

In time, those better experiments came together. After a decade of trial and error, Karik and her longtime collaborator at Penn Drew Weissman, an immunologist with a medical degree and Ph.D. from Boston University discovered a remedy for mRNAs Achilles heel.

The stumbling block, as Kariks many grant rejections pointed out, was that injecting synthetic mRNA typically led to that vexing immune response; the body sensed a chemical intruder, and went to war. The solution, Karik and Weissman discovered, was the biological equivalent of swapping out a tire.

Every strand of mRNA is made up of five molecular building blocks called nucleosides. But in its altered, synthetic form, one of those building blocks, like a misaligned wheel on a car, was throwing everything off by signaling the immune system. So Karikand Weissman simply subbed it out for a slightly tweaked version, creating a hybrid mRNA that could sneak its way into cells without alerting the bodys defenses.

That was a key discovery, said Norbert Pardi, an assistant professor of medicine at Penn and frequent collaborator. Karik and Weissman figured out that if you incorporate modified nucleosides into mRNA, you can kill two birds with one stone.

That discovery, described in a series of scientific papers starting in 2005, largely flew under the radar at first, said Weissman, but it offered absolution to the mRNA researchers who had kept the faith during the technologys lean years. And it was the starter pistol for the vaccine sprint to come.

And even though the studies by Karik and Weissman went unnoticed by some, they caught the attention of two key scientists one in the United States, another abroad who would later help found Moderna and Pfizers future partner, BioNTech.

Derrick Rossi, a native of Toronto who rooted for the Maple Leafs and sported a soul patch, was a 39-year-old postdoctoral fellow in stem cell biology at Stanford University in 2005 when he read the first paper. Not only did he recognize it as groundbreaking, he now says Karik and Weissman deserve the Nobel Prize in chemistry.

If anyone asks me whom to vote for some day down the line, I would put them front and center, he said. That fundamental discovery is going to go into medicines that help the world.

But Rossi didnt have vaccines on his mind when he set out to build on their findings in 2007 as a new assistant professor at Harvard Medical School running his own lab.

He wondered whether modified messenger RNA might hold the key to obtaining something else researchers desperately wanted: a new source of embryonic stem cells.

In a feat of biological alchemy, embryonic stem cells can turn into any type of cell in the body. That gives them the potential to treat a dizzying array of conditions, from Parkinsons disease to spinal cord injuries.

But using those cells for research had created an ethical firestorm because they are harvested from discarded embryos.

Rossi thought he might be able to sidestep the controversy. He would use modified messenger molecules to reprogram adult cells so that they acted like embryonic stem cells.

He asked a postdoctoral fellow in his lab to explore the idea. In 2009, after more than a year of work, the postdoc waved Rossi over to a microscope. Rossi peered through the lens and saw something extraordinary: a plate full of the very cells he had hoped to create.

Rossi excitedly informed his colleague Timothy Springer, another professor at Harvard Medical School and a biotech entrepreneur. Recognizing the commercial potential, Springer contacted Robert Langer, the prolific inventor and biomedical engineering professor at the Massachusetts Institute of Technology.

On a May afternoon in 2010, Rossi and Springer visited Langer at his laboratory in Cambridge. What happened at the two-hour meeting and in the days that followed has become the stuff of legend and an ego-bruising squabble.

Langer is a towering figure in biotechnology and an expert on drug-delivery technology. At least 400 drug and medical device companies have licensed his patents. His office walls display many of his 250 major awards, including the Charles Stark Draper Prize, considered the equivalent of the Nobel Prize for engineers.

As he listened to Rossi describe his use of modified mRNA, Langer recalled, he realized the young professor had discovered something far bigger than a novel way to create stem cells. Cloaking mRNA so it could slip into cells to produce proteins had a staggering number of applications, Langer thought, and might even save millions of lives.

I think you can do a lot better than that, Langer recalled telling Rossi, referring to stem cells. I think you could make new drugs, new vaccines everything.

Langer could barely contain his excitement when he got home to his wife.

This could be the most successful company in history, he remembered telling her, even though no company existed yet.

Three days later Rossi made another presentation, to the leaders of Flagship Ventures. Founded and run by Noubar Afeyan, a swaggering entrepreneur, the Cambridge venture capital firm has created dozens of biotech startups. Afeyan had the same enthusiastic reaction as Langer, saying in a 2015 article in Nature that Rossis innovation was intriguing instantaneously.

Within several months, Rossi, Langer, Afeyan, and another physician-researcher at Harvard formed the firm Moderna a new word combining modified and RNA.

Springer was the first investor to pledge money, Rossi said. In a 2012 Moderna news release, Afeyan said the firms promise rivals that of the earliest biotechnology companies over 30 years ago adding an entirely new drug category to the pharmaceutical arsenal.

But although Moderna has made each of the founders hundreds of millions of dollars even before the company had produced a single product Rossis account is marked by bitterness. In interviews with the Globe in October, he accused Langer and Afeyan of propagating a condescending myth that he didnt understand his discoverys full potential until they pointed it out to him.

Its total malarkey, said Rossi, who ended his affiliation with Moderna in 2014. Im embarrassed for them. Everybody in the know actually just shakes their heads.

Rossi said that the slide decks he used in his presentation to Flagship noted that his discovery could lead to new medicines. Thats the thing Noubar has used to turn Flagship into a big company, and he says it was totally his idea, Rossi said.

Afeyan, the chair of Moderna, recently credited Rossi with advancing the work of the Penn scientists. But, he said, that only spurred Afeyan and Langer to ask the question, Could you think of a code molecule that helps you make anything you want within the body?

Langer, for his part, told STAT and the Globe that Rossi made an important finding but had focused almost entirely on the stem cell thing.

Despite the squabbling that followed the birth of Moderna, other scientists also saw messenger RNA as potentially revolutionary.

In Mainz, Germany, situated on the left bank of the Rhine, another new company was being formed by a married team of researchers who would also see the vast potential for the technology, though vaccines for infectious diseases werent on top of their list then.

A native of Turkey, Ugur Sahin moved to Germany after his father got a job at a Ford factory in Cologne. His wife, zlem Treci had, as a child, followed her father, a surgeon, on his rounds at a Catholic hospital. She and Sahin are physicians who met in 1990 working at a hospital in Saarland.

The couple have long been interested in immunotherapy, which harnesses the immune system to fight cancer and has become one of the most exciting innovations in medicine in recent decades. In particular, they were tantalized by the possibility of creating personalized vaccines that teach the immune system to eliminate cancer cells.

Both see themselves as scientists first and foremost. But they are also formidable entrepreneurs. After they co-founded another biotech, the couple persuaded twin brothers who had invested in that firm, Thomas and Andreas Strungmann, to spin out a new company that would develop cancer vaccines that relied on mRNA.

That became BioNTech, another blended name, derived from Biopharmaceutical New Technologies. Its U.S. headquarters is in Cambridge. Sahin is the CEO, Treci the chief medical officer.

We are one of the leaders in messenger RNA, but we dont consider ourselves a messenger RNA company, said Sahin, also a professor at the Mainz University Medical Center. We consider ourselves an immunotherapy company.

Like Moderna, BioNTech licensed technology developed by the Pennsylvania scientist whose work was long ignored, Karik, and her collaborator, Weissman. In fact, in 2013, the company hired Karik as senior vice president to help oversee its mRNA work.

But in their early years, the two biotechs operated in very different ways.

In 2011, Moderna hired the CEO who would personify its brash approach to the business of biotech.

Stphane Bancel was a rising star in the life sciences, a chemical engineer with a Harvard MBA who was known as a businessman, not a scientist. At just 34, he became CEO of the French diagnostics firm BioMrieux in 2007 but was wooed away to Moderna four years later by Afeyan.

Moderna made a splash in 2012 with the announcement that it had raised $40 million from venture capitalists despite being years away from testing its science in humans. Four months later, the British pharmaceutical giant AstraZeneca agreed to pay Moderna a staggering $240 million for the rights to dozens of mRNA drugs that did not yet exist.

The biotech had no scientific publications to its name and hadnt shared a shred of data publicly. Yet it somehow convinced investors and multinational drug makers that its scientific findings and expertise were destined to change the world. Under Bancels leadership, Moderna would raise more than $1 billion in investments and partnership funds over the next five years.

Modernas promise and the more than $2 billion it raised before going public in 2018 hinged on creating a fleet of mRNA medicines that could be safely dosed over and over. But behind the scenes the companys scientists were running into a familiar problem. In animal studies, the ideal dose of their leading mRNA therapy was triggering dangerous immune reactions the kind for which Karik had improvised a major workaround under some conditions but a lower dose had proved too weak to show any benefits.

Moderna had to pivot. If repeated doses of mRNA were too toxic to test in human beings, the company would have to rely on something that takes only one or two injections to show an effect. Gradually, biotechs self-proclaimed disruptor became a vaccines company, putting its experimental drugs on the back burner and talking up the potential of a field long considered a loss-leader by the drug industry.

Meanwhile BioNTech has often acted like the anti-Moderna, garnering far less attention.

In part, that was by design, said Sahin. For the first five years, the firm operated in what Sahin called submarine mode, issuing no news releases, and focusing on scientific research, much of it originating in his university lab. Unlike Moderna, the firm has published its research from the start, including about 150 scientific papers in just the past eight years.

In 2013, the firm began disclosing its ambitions to transform the treatment of cancer and soon announced a series of eight partnerships with major drug makers. BioNTech has 13 compounds in clinical trials for a variety of illnesses but, like Moderna, has yet to get a product approved.

When BioNTech went public last October, it raised $150 million, and closed with a market value of $3.4 billion less than half of Modernas when it went public in 2018.

Despite his role as CEO, Sahin has largely maintained the air of an academic. He still uses his university email address and rides a 20-year-old mountain bicycle from his home to the office because he doesnt have a drivers license.

Then, late last year, the world changed.

Shortly before midnight, on Dec. 30, the International Society for Infectious Diseases, a Massachusetts-based nonprofit, posted an alarming report online. A number of people in Wuhan, a city of more than 11 million people in central China, had been diagnosed with unexplained pneumonia.

Chinese researchers soon identified 41 hospitalized patients with the disease. Most had visited the Wuhan South China Seafood Market. Vendors sold live wild animals, from bamboo rats to ostriches, in crowded stalls. That raised concerns that the virus might have leaped from an animal, possibly a bat, to humans.

After isolating the virus from patients, Chinese scientists on Jan. 10 posted online its genetic sequence. Because companies that work with messenger RNA dont need the virus itself to create a vaccine, just a computer that tells scientists what chemicals to put together and in what order, researchers at Moderna, BioNTech, and other companies got to work.

A pandemic loomed. The companies focus on vaccines could not have been more fortuitous.

Moderna and BioNTech each designed a tiny snip of genetic code that could be deployed into cells to stimulate a coronavirus immune response. The two vaccines differ in their chemical structures, how the substances are made, and how they deliver mRNA into cells. Both vaccines require two shots a few weeks apart.

The biotechs were competing against dozens of other groups that employed varying vaccine-making approaches, including the traditional, more time-consuming method of using an inactivated virus to produce an immune response.

Moderna was especially well-positioned for this moment.

Forty-two days after the genetic code was released, Modernas CEO Bancel opened an email on Feb. 24 on his cellphone and smiled, as he recalled to the Globe. Up popped a photograph of a box placed inside a refrigerated truck at the Norwood plant and bound for the National Institute of Allergy and Infectious Diseases in Bethesda, Md. The package held a few hundred vials, each containing the experimental vaccine.

Moderna was the first drug maker to deliver a potential vaccine for clinical trials. Soon, its vaccine became the first to undergo testing on humans, in a small early-stage trial. And on July 28, it became the first to start getting tested in a late-stage trial in a scene that reflected the firms receptiveness to press coverage.

The first volunteer to get a shot in Modernas late-stage trial was a television anchor at the CNN affiliate in Savannah, Ga., a move that raised eyebrows at rival vaccine makers.

Along with those achievements, Moderna has repeatedly stirred controversy.

On May 18, Moderna issued a press release trumpeting positive interim clinical data. The firm said its vaccine had generated neutralizing antibodies in the first eight volunteers in the early-phase study, a tiny sample.

But Moderna didnt provide any backup data, making it hard to assess how encouraging the results were. Nonetheless, Modernas share price rose 20% that day.

Some top Moderna executives also drew criticism for selling shares worth millions, including Bancel and the firms chief medical officer, Tal Zaks.

In addition, some critics have said the government has given Moderna a sweetheart deal by bankrolling the costs for developing the vaccine and pledging to buy at least 100 million doses, all for $2.48 billion.

That works out to roughly $25 a dose, which Moderna acknowledges includes a profit.

In contrast, the government has pledged more than $1 billion to Johnson & Johnson to manufacture and provide at least 100 million doses of its vaccine, which uses different technology than mRNA. But J&J, which collaborated with Beth Israel Deaconess Medical Centers Center for Virology and Vaccine Research and is also in a late-stage trial, has promised not to profit off sales of the vaccine during the pandemic.

Over in Germany, Sahin, the head of BioNTech, said a Lancet article in January about the outbreak in Wuhan, an international hub, galvanized him.

We understood that this would become a pandemic, he said.

The next day, he met with his leadership team.

I told them that we have to deal with a pandemic which is coming to Germany, Sahin recalled.

He also realized he needed a strong partner to manufacture the vaccine and thought of Pfizer. The two companies had worked together before to try to develop mRNA influenza vaccines. In March, he called Pfizers top vaccine expert, Kathrin Jansen.

Here is the original post:
The story of mRNA: From a loose idea to a tool that may help curb Covid - STAT

Spinal Cord Stem Cells Comments Off on The story of mRNA: From a loose idea to a tool that may help curb Covid – STAT | November 10th, 2020

DUBLIN, Nov. 9, 2020 /PRNewswire/ -- The "Regenerative Medicine Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2020-2025" report has been added to ResearchAndMarkets.com's offering.

The global regenerative medicine market grew at a CAGR of around 16% during 2014-2019. Regenerative medicine refers to a branch of biomedical sciences aimed at restoring the structure and function of damaged tissues and organs. It involves the utilization of stem cells that are developed in laboratories and further implanted safely into the body for the regeneration of damaged bones, cartilage, blood vessels and organs. Cellular and acellular regenerative medicines are commonly used in various clinical therapeutic procedures, including cell, immunomodulation and tissue engineering therapies. They hold potential for the effective treatment of various chronic diseases, such as Alzheimer's, Parkinson's and cardiovascular disorders (CVDs), osteoporosis and spinal cord injuries.

The increasing prevalence of chronic medical ailments and genetic disorders across the globe is one of the key factors driving the growth of the market. Furthermore, the rising geriatric population, which is prone to various musculoskeletal, phonological, dermatological and cardiological disorders, is stimulating the market growth. In line with this, widespread adoption of organ transplantation is also contributing to the market growth. Regenerative medicine minimizes the risk of organ rejection by the body post-transplant and enhances the recovery speed of the patient.

Additionally, various technological advancements in cell-based therapies, such as the development of 3D bioprinting techniques and the adoption of artificial intelligence (AI) in the production of regenerative medicines, are acting as other growth-inducing factors. These advancements also aid in conducting efficient dermatological grafting procedures to treat chronic burns, bone defects and wounds on the skin. Other factors, including extensive research and development (R&D) activities in the field of medical sciences, along with improving healthcare infrastructure, are anticipated to drive the market further. Looking forward, the publisher expects the global regenerative medicine market to continue its strong growth during the next five years.

Competitive Landscape:

The report has also analysed the competitive landscape of the market with some of the key players being Allergan PLC (AbbVie Inc.), Amgen Inc., Baxter International Inc., BD (Becton, Dickinson and Company), Integra Lifesciences Holdings Corporation, Medtronic plc, Mimedx Group Inc., Novartis AG, Osiris Therapeutics Inc. (Smith & Nephew plc) and Thermo Fisher Scientific Inc.

Key Questions Answered in This Report:

Key Topics Covered:

1 Preface

2 Scope and Methodology 2.1 Objectives of the Study2.2 Stakeholders2.3 Data Sources2.3.1 Primary Sources2.3.2 Secondary Sources2.4 Market Estimation2.4.1 Bottom-Up Approach2.4.2 Top-Down Approach2.5 Forecasting Methodology

3 Executive Summary

4 Introduction4.1 Overview4.2 Key Industry Trends

5 Global Regenerative Medicine Market5.1 Market Overview5.2 Market Performance5.3 Impact of COVID-195.4 Market Forecast

6 Market Breakup by Type6.1 Stem Cell Therapy6.1.1 Market Trends6.1.2 Market Forecast6.2 Biomaterial6.2.1 Market Trends6.2.2 Market Forecast6.3 Tissue Engineering6.3.1 Market Trends6.3.2 Market Forecast6.4 Others6.4.1 Market Trends6.4.2 Market Forecast

7 Market Breakup by Application7.1 Bone Graft Substitutes7.1.1 Market Trends7.1.2 Market Forecast7.2 Osteoarticular Diseases7.2.1 Market Trends7.2.2 Market Forecast7.3 Dermatology7.3.1 Market Trends7.3.2 Market Forecast7.4 Cardiovascular7.4.1 Market Trends7.4.2 Market Forecast7.5 Central Nervous System7.5.1 Market Trends7.5.2 Market Forecast7.6 Others7.6.1 Market Trends7.6.2 Market Forecast

8 Market Breakup by End User8.1 Hospitals8.1.1 Market Trends8.1.2 Market Forecast8.2 Specialty Clinics8.2.1 Market Trends8.2.2 Market Forecast8.3 Others8.3.1 Market Trends8.3.2 Market Forecast

9 Market Breakup by Region9.1 North America9.1.1 United States9.1.1.1 Market Trends9.1.1.2 Market Forecast9.1.2 Canada9.1.2.1 Market Trends9.1.2.2 Market Forecast9.2 Asia Pacific9.2.1 China9.2.1.1 Market Trends9.2.1.2 Market Forecast9.2.2 Japan9.2.2.1 Market Trends9.2.2.2 Market Forecast9.2.3 India9.2.3.1 Market Trends9.2.3.2 Market Forecast9.2.4 South Korea9.2.4.1 Market Trends9.2.4.2 Market Forecast9.2.5 Australia9.2.5.1 Market Trends9.2.5.2 Market Forecast9.2.6 Indonesia9.2.6.1 Market Trends9.2.6.2 Market Forecast9.2.7 Others9.2.7.1 Market Trends9.2.7.2 Market Forecast9.3 Europe9.3.1 Germany9.3.1.1 Market Trends9.3.1.2 Market Forecast9.3.2 France9.3.2.1 Market Trends9.3.2.2 Market Forecast9.3.3 United Kingdom9.3.3.1 Market Trends9.3.3.2 Market Forecast9.3.4 Italy9.3.4.1 Market Trends9.3.4.2 Market Forecast9.3.5 Spain9.3.5.1 Market Trends9.3.5.2 Market Forecast9.3.6 Russia9.3.6.1 Market Trends9.3.6.2 Market Forecast9.3.7 Others9.3.7.1 Market Trends9.3.7.2 Market Forecast9.4 Latin America9.4.1 Brazil9.4.1.1 Market Trends9.4.1.2 Market Forecast9.4.2 Mexico9.4.2.1 Market Trends9.4.2.2 Market Forecast9.4.3 Others9.4.3.1 Market Trends9.4.3.2 Market Forecast9.5 Middle East and Africa9.5.1 Market Trends9.5.2 Market Breakup by Country9.5.3 Market Forecast

10 SWOT Analysis10.1 Overview10.2 Strengths10.3 Weaknesses10.4 Opportunities10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis12.1 Overview12.2 Bargaining Power of Buyers12.3 Bargaining Power of Suppliers12.4 Degree of Competition12.5 Threat of New Entrants12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape14.1 Market Structure14.2 Key Players14.3 Profiles of Key Players14.3.1 Allergan PLC (AbbVie Inc.)14.3.1.1 Company Overview14.3.1.2 Product Portfolio 14.3.1.3 Financials 14.3.1.4 SWOT Analysis14.3.2 Amgen Inc.14.3.2.1 Company Overview14.3.2.2 Product Portfolio14.3.2.3 Financials 14.3.2.4 SWOT Analysis14.3.3 Baxter International Inc.14.3.3.1 Company Overview14.3.3.2 Product Portfolio 14.3.3.3 Financials 14.3.3.4 SWOT Analysis14.3.4 BD (Becton, Dickinson and Company)14.3.4.1 Company Overview14.3.4.2 Product Portfolio 14.3.4.3 Financials 14.3.4.4 SWOT Analysis14.3.5 Integra Lifesciences Holdings Corporation14.3.5.1 Company Overview14.3.5.2 Product Portfolio 14.3.5.3 Financials 14.3.5.4 SWOT Analysis14.3.6 Medtronic Plc14.3.6.1 Company Overview14.3.6.2 Product Portfolio 14.3.6.3 Financials14.3.6.4 SWOT Analysis14.3.7 Mimedx Group Inc.14.3.7.1 Company Overview14.3.7.2 Product Portfolio14.3.7.3 Financials 14.3.8 Novartis AG14.3.8.1 Company Overview14.3.8.2 Product Portfolio 14.3.8.3 Financials14.3.8.4 SWOT Analysis14.3.9 Osiris Therapeutics Inc. (Smith & Nephew plc)14.3.9.1 Company Overview14.3.9.2 Product Portfolio14.3.10 Thermo Fisher Scientific Inc.14.3.10.1 Company Overview14.3.10.2 Product Portfolio 14.3.10.3 Financials14.3.10.4 SWOT Analysis

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

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Originally posted here:
Worldwide Regenerative Medicine Industry to 2025 - Featuring Allergan, Amgen and Baxter International Among Others - PRNewswire

Spinal Cord Stem Cells Comments Off on Worldwide Regenerative Medicine Industry to 2025 – Featuring Allergan, Amgen and Baxter International Among Others – PRNewswire | November 10th, 2020