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News Alert | Aspen Xchange

News Alert

The U.S. FDA is planning a rapid review process for quick turnaround of new COVID-19 booster shots if variants of the coronavirus emerge against which the vaccines do not provide protection, the agency’s top official says. Dr. Janet Woodcock, acting commissioner of the FDA, said that if new variants of the coronavirus emerge that require booster shots or changes to vaccines, the agency will not require the type of large trials that were required for emergency use authorization or approval. The agency plans to issue a proposal on the process for public comment in a few weeks, she said during a press briefing.
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A phase 2 clinical trial of venglustat in Parkinson’s disease patients has failed, prompting Sanofi to stop work in the indication. Sanofi disclosed the setback alongside news that it is stopping work on a clutch of other midphase programs. The setback still leaves Sanofi with chances to get venglustat to market. Sanofi is enrolling, or set to start enrolling, patients in several phase 2/3 clinical trials. Those studies are targeting autosomal dominant polycystic kidney disease, late-onset GM2 gangliosidosis and Gaucher disease.
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Merck KGaA and BioNTech are further expanding their strategic partnership. Merck KGaA, in close collaboration with BioNTech, will significantly accelerate the supply of urgently needed lipids and increase the amount of lipid delivery towards the end of 2021. The lipids will be used for the production of the Pfizer-BioNTech Covid-19 Vaccine (BNT162b2). Lipids are critical to the drug delivery system of mRNA therapies to the body for a vaccine to be effective. Only very few companies in the world are currently able to produce custom lipids in significant quantities and according to the highest quality requirements needed for vaccine production.
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Johnson & Johnson says it has asked the FDA for emergency authorization of its coronavirus vaccine, submitting an application less than one week after announcing a single shot protected volunteers in a large study from developing COVID-19. With the application in, the FDA will begin reviewing data from that trial, which showed vaccination was 66% effective in preventing moderate or severe disease. Protection was greater, at 85%, against just severe disease and there were no deaths related to COVID-19 among participants who received the shot.
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Kenneth Frazier is stepping down as the CEO of Merck, leaving a giant hole in the fabric of the biopharma industry. The decision, announced this week, has been telegraphed for more than a year, but is still a landmark moment. Frazier, 66, has done more than oversee the reanimation of one the most fabled U.S. drug makers; in recent years, he’s been the heart of the drug industry. He will be replaced by Merck’s chief financial officer, Robert Davis, but will remain as the company’s executive chairman for an indeterminate period of time.
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CytoImmune Therapeutics and Biosimilar Sciences have made public plans to establish operations in Puerto Rico to develop their biotechnology products. For its part CytoImmune Therapeutics will invest $28 million for a facility to engage in developing cancer immunotherapy solutions. While Biosimilar Sciences will invest $200 million to establish a state-of-the-art biotech facility for the development of biosimilar products, including a COVID-19 vaccine, new cell and gene therapy, biologics, clinical studies, and other recombinant biotechnologies.
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Jazz Pharmaceuticals has agreed to buy GW Pharmaceuticals in a $7.2 billion cash-and-stock deal which will bolster its neuroscience business with the addition of a cannabis-based epilepsy treatment. GW Pharma’s Epidiolex, the first marijuana-derived drug to be approved in the United States, generated sales of over $500 million last year. Analysts expect sales to breach $1 billion soon. Jazz Chairman and Chief Executive Bruce Cozadd said in an interview that in GW, Jazz is getting “a near-term blockbuster product in Epidiolex and a really exciting scientific platform around cannabinoid medicines, with early-to-late-stage clinical programs already in place.”
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GSK and CureVac have teamed up in a deal valued at $180 million that will see GSK pay $90 million upfront to develop a COVID-19 vaccine that could target several variants with one shot. A second payment of $90 million will be owed to CureVac should certain well-defined milestones are met. For GSK the deal marks a fresh attempt to play a major role in fighting the pandemic after a COVID-19 alliance with Sanofi ran into delays and a collaboration with China’s Clover Biopharmaceuticals was ended. An additional element of the deal will see GSK join Bayer in also supporting the production of CureVac’s first generation COVID-19 vaccine candidate in 2021.
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Researchers from Cornell and Northwestern University have devised a new method of using extracts derived from bioengineered bacteria to create vaccines that protect against life-threatening infections caused by pathogenic bacteria. Because the technology can be easily reconfigured for different pathogenic foes and freeze-dried for portability and refrigeration-free storage, it could be a game-changing approach to fighting infection, especially in locations where access to such medicines is limited. The team’s paper, “On-Demand Biomanufacturing of Protective Conjugate Vaccines,” was published this week in Science Advances.
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Breast cancer has overtaken lung cancer as the most common form of the disease, with an estimated 2.3 million new cases diagnosed last year. This represents nearly 12% of all new cancer cases worldwide, the World Health Organization said this week. “For the first time, breast cancer now constitutes the most commonly occurring cancer globally,” Andre Ilbawi, a cancer specialist at the WHO, told a U.N. briefing ahead of World Cancer Day. Lung cancer was the most common type for the last two decades, but is now in second place, ahead of colorectal cancer, which is the third most widespread, Ilbawi said.
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Pfizer plans to deliver 200 million doses of its coronavirus vaccine to the U.S. by May, earlier than its initial forecast of July, according to slides published this week by the drugmaker ahead of its fourth-quarter earnings call. The company, which developed its vaccine with German drugmaker BioNTech, also said it can potentially deliver 2 billion doses globally by the end of this year now that health-care providers can extract an additional sixth dose of the vaccine from the vials. Pfizer had delivered 29 million doses of its two-shot vaccine to the U.S. government as of Jan. 31, according to the company. As of Monday, 17 million of those Pfizer doses have been administered, according to the Centers for Disease Control and Prevention.
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Bristol Myers Squibb has announced that WuXi STA has agreed to purchase its manufacturing facility in Couvet, Switzerland. The Couvet site will be the first facility in Europe for WuXi STA. The companies anticipate completing the transaction by Q2 2021, subject to regulatory approvals and the satisfaction of other closing conditions. Upon closing, WuXi STA will acquire the Couvet site’s operations and assets, which include the plant and equipment, as well as a workforce with technical capabilities and expertise.
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Horizon Therapeutics says it will purchase Viela Bio for about $3.1 billion to expand its portfolio and pipeline of treatments for rare diseases. The transaction is expected to close by the end of the first quarter. The purchase will add Viela Bio’s Uplizna, an approved treatment for a rare autoimmune disease that attacks vision, to Horizon’s offerings. The drug is one of four the biotech has been developing for different immune-system-related conditions. AstraZeneca agreed to divest its 27% interest in Viela Bio, for which it will receive proceeds and profit of about $760 million to $780 million, according to a separate statement.
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Bayer will help CureVac manufacture tens of millions more doses of the biotech's experimental coronavirus vaccine beginning as soon as the end of this year, company executives said in a briefing with the German health minister. Bayer and CureVac are already co-developing the vaccine, with the large pharma providing support for clinical testing and regulatory discussions in other countries. Now, after discussions with the German government, Bayer has also agreed to make 160 million doses of CureVac's shot in 2022.
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Building on a successful leukocyte growth factor for chemo patients, Coherus is expanding its mission to include immuno-oncology. The California-based biosimilar company shelled out $150 million for U.S. and Canadian rights to Junshi Biosciences’ toripalimab. Toripalimab is China’s first anti-PD-1 monoclonal antibody to receive approval in its own country and appears well on its way to FDA approval as well. Drugs like Junshi’s work to inhibit the immune system’s checkpoint protein PD-1. Three of these types of drugs have already been approved by the FDA – Keytruda, Opdivo and Libtayo.
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At a conference sponsored by the Parenteral Drug Association last week, speakers demonstrated that our industry has developed best practices for auditors and/or regulatory inspectors to conduct virtual inspections. These are inspections in which the auditor or inspector is not physically on-site, but, instead, conducts the inspection remotely through audio or video streaming techniques, or both, of drug-manufacturing facilities. Such an approach has become increasingly common by drug companies of their CMO’s and by other biopharma regulatory agencies worldwide. Begging the question, why doesn’t the US FDA?
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Biogen and partner Eisai have made public a decision by the U.S. FDA to extend the review period for their experimental Alzheimer’s disease treatment by three months from March to June 7th. This comes after an expert panel responsible for advising the FDA voted against the drug in November. The FDA is not obligated to follow the recommendations of the panel, but usually does. An FDA approval would make the drug, aducanumab, the first new treatment for Alzheimer’s in decades and the first that appears to be able to slow progression of the fatal, mind-wasting condition that affects millions of people.
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Novartis has signed an initial agreement to provide manufacturing capacity for Pfizer and Biontech’s COVID-19 vaccine, a move aimed at helping boost production as supplies fall shy of demand. Subject to reaching a final agreement, Novartis plans to commence production in the second quarter of 2021, adding it would use manufacturing facilities at its site in Stein, Switzerland, near the Rhine River on the German border. Novartis’s announcement that it was joining the push to remedy the shortfall follows a recent move by Sanofi to work with Biontech to supply 125 million doses of its mRNA vaccine to the European Union.
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A newly unveiled partnership between Cambridge Quantum Computing and Roche lays down a marker for what could prove to be a global drug discovery revolution in the next few years. The collaboration, centered around neurodegenerative diseases, is seen by many as a significant opportunity. It is just one market among many for large proteins, mostly in the form of antibody therapeutics, said to be worth close to $200 billion and quantum computing is expected to play a critical role. According to reports the two partners will seek to design and implement algorithms for early-stage drug discovery and development specific to Alzheimer’s.
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A first-of-its-kind drug developed by Amgen shrank tumors in a little over a third of lung cancer patients enrolled into a mid-sized study, affirming promising results from an earlier trial that had excited oncologists and made the medicine one of the most closely watched in biotech. The drug, called sotorasib, is aimed at tumors that have been driven to growth by mutations in a gene called KRAS. Most common in lung, colon and pancreatic cancers, KRAS mutations have defeated scientists' best efforts to design targeted treatments for more than 30 years. Data released this week showed 37%, of participants in the study responded to treatment. Three patients' cancers disappeared entirely.
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Europe’s fight to secure COVID-19 vaccine supplies intensified this week when the EU warned drug companies such as AstraZeneca that it would use all legal means or even block exports unless they agreed to deliver shots as promised. The EU, whose member states are far behind Israel, the United Kingdom and the United States in rolling out vaccines, is scrambling to get supplies just as the West’s biggest drugmakers slow deliveries to the bloc due to production problems. European Council President Charles Michel said in a letter that the EU should explore legal means to ensure supplies of vaccines it contracted to buy, if negotiations with companies over delayed deliveries are unsuccessful.
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A bomb disposal unit was called this week to a UK factory where doses of the AstraZeneca/Oxford Covid-19 vaccine are manufactured after the plant received a suspicious package. The Wockhardt UK plant in Wrexham, north Wales, was evacuated while the package was made safe. The incident came only hours after AstraZeneca refuted EU claims that the pharmaceutical company was selling vaccine doses to the highest bidder. Police did not clarify whether the package had posed a threat but said the contents would be analyzed and there would be an investigation into the circumstances.
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Eli Lilly, Vir Biotechnology and GSK will team up in an unusual alliance to evaluate two of their COVID-19 antibody drugs together as a combination treatment. A planned trial will test Lilly's antibody drug bamlanivimab with Vir's medicine VIR-7831 in mild to moderate COVID-19 patients at "low risk" of disease progression. Though Lilly already has a two-drug regimen under review by the FDA, Vir's drug works differently. Lilly said it aims to develop drugs for "current and future strains of COVID-19." The alliance is part of a growing push by drugmakers to deal with new coronavirus variants emerging across the world.
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A year ago, hundreds of desperate consumers were emailing Mike Bowen's Texas medical supply factory every day, looking to buy N95 medical respirator masks that can filter viruses. Today, most consumers still aren't able to buy N95 masks, because the supply available to retailers remains very limited. Even hospital workers are still being asked to ration and reuse their supplies of N95s, and the website of the CDC says, "N-95 respirators should not be used because they should be conserved for healthcare personnel." This article by NPR explores the reasons behind the ongoing shortage in supply.
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Regeneron said this week that its antibody cocktail was found effective in preventing COVID-19 in people exposed to those infected with the new coronavirus in an ongoing late stage trial. The two-antibody cocktail, REGEN-COV, caused a 100% reduction in symptomatic infection and roughly 50% lower overall rates of infection, based on an early analysis of 400 participants in the trial who had a household member with COVID-19. In comparison, rival Eli Lilly and Co said last week its antibody drug, bamlanivimab, cut the risk of COVID-19 infection by 80% for nursing home residents in a trial.
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Sanofi will help manufacture more than 100 million doses of Pfizer and BioNTech's coronavirus vaccine, agreeing to lend spare production capacity to the partner companies after setbacks and delays in the development of its own vaccine candidates. The additional doses will be used only for supplying European Union countries, a company spokesperson confirmed to BioPharma Dive, with initial deliveries expected by August. Sanofi will use a plant in Frankfurt, Germany, to fill and package vials of Pfizer and BioNTech's vaccine. Pfizer and BioNTech have said they can produce some 2 billion doses this year, but demand has widely outstripped supply.
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The European Commission will finalize a proposal by the end of the week to require pharmaceutical firms to register their vaccine exports from the European Union, while insisting it had no plans to impose an export ban. This move comes after EU countries learnt late last week that deliveries of the vaccine from AstraZeneca, which is expected to be approved on Friday, would be some 60% lower in the first quarter than initially indicated. There have also been reduced deliveries of a vaccine jointly produced by Pfizer and BioNTech.
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For the first time, the FDA has approved an oral medicine for a kidney disease that is caused by lupus and can lead to kidney failure, heart complications and death. The medicine, now known as Lupkynis, is given alongside immunosuppressants to treat adults with active lupus nephritis. Historically, repurposed anti-inflammation drugs, steroids, immunosuppressants and antimalarials have been used to manage lupus symptoms. But it wasn't until 2011 that a drug specifically developed for the disease, GlaxoSmithKline's Benlysta, became available. Benlysta is an antibody therapy given through an intravenous injection.
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Moderna will develop a Covid-19 booster shot designed to be more effective against emerging strains of the coronavirus, the Massachusetts manufacturer announced this week. New strains of the coronavirus have emerged in the United Kingdom, South Africa and Brazil, along with concerns that they could make vaccines less effective and be more transmissible or deadly. To that end, Moderna is testing two booster-shot options — one specifically aimed at the South African variant and another to broadly fight new mutations.
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Drugmaker Merck & Co has announced that it will stop development of its two COVID-19 vaccines. This comes after the biopharma giant was late to join the race to develop a vaccine to protect against the coronavirus. Acquiring vaccine candidate V591 through the purchase of Themis Bioscience and V590 which was developed with IAVI. In early trials, both vaccines generated immune responses that were inferior to those seen in people who had recovered from COVID-19 as well as those reported for other COVID-19 vaccines. The announcement comes a month after Sanofi and GSK delayed launch of their shot to late 2021.
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Civica has announced plans to invest $124.5 million to establish its North American manufacturing headquarters operation in Petersburg, Virginia. The company plans to construct a 120,000-square-foot manufacturing facility in Petersburg, where it will manufacture vials and syringes of injectable medicines used for COVID- 19 patient care, emergency rooms and surgeries, as well as the treatment of serious infections and hypertension. The new plant is part of a larger federal strategy to establish an American manufacturing hub and supply chain for generic medicines and pharmaceutical ingredients needed to treat COVID-19 
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The Biotechnology Innovation Organization (BIO) has made “some staff reductions” as it faces up to the prospect of another year without the face-to-face events that were central to its pre-pandemic operation. A typical pre-pandemic year for BIO featured a steady stream of in-person events. This time two years ago, the trade group had 13 face-to-face events lined up for 2019 around the world, including its flagship BIO International Convention. Today, following a year ravaged by the pandemic, BIO has a smaller, largely digital schedule.
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Charles S. Fuchs, director of Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital, has been named senior vice president and global head of product development for oncology and hematology at Roche and Genentech. Fuchs, the Richard Sackler and Jonathan Sackler Professor of Medicine and professor of chronic disease epidemiology at Yale, will start in the new role at Roche and Genentech on March 1 of this year. He will be based out of Genentech’s operations in South San Francisco, California.
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At least five people were killed in a fire that broke out at a building under construction at Serum Institute of India’s site in Pune. According to published reports the victims of the fire, the cause of which has yet to be determined, were most likely construction workers. The company said the fire was restricted to a new facility it is constructing to increase the production of COVID-19 vaccines and ensure it is better prepared for future pandemics. Serum Institute of India is the world’s largest maker of vaccines and has been contracted to manufacture a billion doses of the AstraZeneca/Oxford University vaccine.
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Northway Biotech has opened its new 30,000-square-foot process development and cGMP manufacturing site in Waltham, Massachusetts. From cell line development to cGMP DS manufacturing and aseptic filling, the state-of-the-art facility, in the booming biotech hub in the Greater Boston area, will provide end-to-end services for biologics microbial and mammalian-based biologics. The cGMP biomanufacturing suite will house 500 L microbial and 2,000 L mammalian bioreactors and be operational in Q4 2021, representing a capital investment program worth $40 million.
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Sartorius Stedim Biotech has committed $1.5 million to Penn State to create the Sartorius Cell Culture Facility, which will expand Penn State’s biotechnology ecosystem. Sartorius’ gift expands their partnership with Penn State to advance multidisciplinary teaching and research in biotechnology through hands-on experiences for undergraduate and graduate students and corporate employees and providing exposure to research innovations across numerous fields. The Sartorius Cell Culture Facility, part of the Huck Institutes of the Life Sciences, will be the third leg in the biotechnology ecosystem that includes the Center of Excellence in Industrial Biotechnology and the CSL Behring Fermentation Facility.
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The Covid-19 vaccine from Pfizer-BioNTech appears to work just as well against a fast-spreading variant of the coronavirus first identified in the United Kingdom as it does against earlier forms of the pathogen. The paper from company scientists, which has not yet been peer-reviewed, is a welcome signal that existing vaccines don’t seem to be weakened by the variant in question, dubbed B.1.1.7. Already, scientists had tested the Pfizer vaccine against one of the key mutations in the variant and found the immunization’s neutralization power was not affected. Scientists are also testing vaccines against other variants of concern, which contain different mutations.
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Construction consultant Turner & Townsend is calling on pharmaceutical companies to share data on their construction projects after it found in a survey that 70% of such projects exceeded their budgets by an average of 15% and their schedule by an average of four months. It says benchmarking data on the construction of new plants would identify common risks and help drug companies get plants producing faster. According to the survey the overruns are typically driven by overspending and delays during the commissioning, qualification and validation phase (CQV) at the end of a project, plus a failure to accurately anticipate the time and resources needed to complete utility and mechanical, engineering and plumbing (MEP) work.
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Some 200 workers with union flags and megaphones gathered outside the entrance to the sprawling Sanofi research and development facility in Marcy l’Etoile in central France this week. They said that hundreds of planned job cuts in France could slow the fight against the coronavirus pandemic. The company announced last year it plans 1,000 job cuts across France over three years “to reinforce the effectiveness of our organization and adapt to the evolution of jobs and stakes of tomorrow.” It said in a statement that it would rely on voluntary departures but wouldn’t comment further because of confidentiality rules amid ongoing negotiations with unions.
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The U.S. Supreme Court this week rejected Merck & Co’s bid to revive a $2.54 billion jury verdict it won against rival drugmaker Gilead Sciences for infringing a patent in a dispute over a blockbuster hepatitis C treatment. The justices declined to take up Merck’s appeal of a lower court’s ruling that overturned the massive damages verdict after finding that Merck’s patent was invalid. In its appeal to the Supreme Court, Merck said that the Federal Circuit’s ruling undermined biotechnology breakthroughs in which discoveries often begin with a family of compounds that share a particular property.
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AbbVie has brought a “precautionary” High Court action against the Ireland’s Revenue service arising from a $712 million (€587 million) tax bill served on it after it acquired Allergen. This latest legal filing comes after a decision by the Tax Appeals Commissioner (TAC) last week to accept an appeal by AbbVie to have the tax bill reduced to zero. In response the Revenue service filed its own appeal to Ireland’s High Court, arguing that the commissioner did not have the jurisdiction to make that ruling. The matter is expected to return before the courts in late March.
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A federal judge has rejected convicted pharmaceutical executive’s Martin Shkreli’s second request to be let out of prison early, showing skepticism about his claim in court papers that mental health issues have weakened his immune system and made him more susceptible to contracting the coronavirus. U.S. District Judge Kiyo Matsumoto said in a 12-page ruling that Shkreli again failed to demonstrate extraordinary and compelling factors that would require a sentence modification, such as release under home confinement rules designed to move vulnerable inmates out of institutions during the pandemic.
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When medical historians write about the coronavirus pandemic, they’ll likely focus on the negatives that led to a tragically high death toll. But that will be only part of the story. From the wreckage and devastation will emerge something few contemporary observers would expect: a brighter future for American healthcare. Five technologies, all previously underappreciated and underutilized, will help our nation move past the coronavirus crisis into a new, golden era of medicine. Turning U.S. healthcare’s outdated and broken system into one that is more convenient, effective and affordable.
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The top concern for Bayer’s pharma business is the looming patent cliff for its two best-sellers—blood thinner Xalreto and eye drug Eylea. The blockbuster meds will leave a revenue gap that the company’s pipeline program won’t be able to fill in the next few years. Together, Xarelto and Eylea chalked up $8.0 billion (€6.62 billion) in 2019 revenues after double-digit growth. It would be “mathematically impossible” for growth from newer drugs to compensate for their loss of patent protection, Bayer pharma chief, Stefan Oelrich, recently told reporters according to The Financial Times.
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Sana Biotechnology, a startup which is developing cell-engineering platforms that it says could change the way many diseases are treated, is poised to go public with a roughly $10 billion price tag a year before it begins human clinical trials for its drug candidates. That isn’t as crazy as it sounds. While drug development is notoriously uncertain, and there is a chance that a Sana drug candidate never reaches the market, the upside of an early investment can be substantial. One need only look to Moderna which went public in late 2018 at a $7 billion valuation, at the time a record for a biotech IPO. Those who bought and held have enjoyed a sevenfold return on their investment in just over two years.
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President-elect Joe Biden has chosen a pioneer in mapping the human genome to be his chief science adviser and is elevating the top science job to a Cabinet position. Biden nominated Eric Lander, founding director of the Broad Institute of MIT and Harvard, who was the lead author of the first paper announcing the details of the human genome, as director of Office of Science and Technology Policy and adviser on science. He is the first life scientist to have that job. His predecessor is a meteorologist. Saying “science will always be at the forefront of my administration,” Biden said he is boosting the science advisor post to Cabinet level, a first in White House history.
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Thermo Fisher has announced the acquisition of Henogen, Novasep's viral vector manufacturing division, for about or $878.2 million (€725 million) in cash. Henogen provides contract manufacturing services from formulation to packaging across two locations in Belgium and maintains over 75,000 square feet of production space and about 400 employees—a recently increased workforce, as the company gears up to support COVID-19 vaccine production. The division will be absorbed into Thermo Fisher’s pharma services business, under its laboratory products segment. Earlier this month, Novasep also sold off its chromatography equipment division to Sartorius, which it described as a disposal aligned with its new core strategy.
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FUJIFILM Corporation and the Center for Advanced Biological Innovation and Manufacturing has announced that it has secured $76 million in financing and signed a lease for a 40,000 square-foot site in Watertown, Massachusetts at The Arsenal on the Charles. The Center will advance research and development in cell and gene therapy, gene editing, immunotherapy, and biotechnology. The industry-academia research and development consortium was established with an equal investment each from Fujifilm, Harvard, MIT, Cytiva, and Alexandria Real Estate Equities to shorten the path to implementation of therapies, and to accelerate the practical application and commercialization of these therapies.
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David Kessler is out of the running for nomination as FDA commissioner, leaving Janet Woodcock and Joshua Sharfstein as front-runners to lead the regulatory agency according to reports from Bloomberg and Biocentury. The latter notes that while the list of candidates had narrowed to Kessler and Sharfstein the delay in naming a candidate for the position could be a sign that other names are being considered. Janet Woodcock, longtime director of the Center for Drug Evaluation and Research (CDER) and a 30-year veteran of the FDA, is expected to be named acting FDA commissioner next week according to sources who spoke on condition of anonymity.
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A former director of medical and scientific affairs for immune oncology at Merck & Co. has been arrested on charges of stealing and illegally transmitting trade secrets. According to reports, Shafat A. Quadri is alleged to have copied proprietary information pertaining to multiple cancer research projects prior to leaving Merck to join AstraZeneca. Court filings state that the materials allegedly include compound data, strategic plans related to translational and biomarker data, therapeutic program reviews, abstract publications, plans for Congressional presentations, drug monitoring, and compound publication.
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Most novel drugs approved by the US FDA in 2020 made their way through the approvals process using one or more expedited approval pathways, and over half of sponsors received the incentives that accompany orphan drug designation, according to an FDA report detailing the year’s approvals. Novel drug approvals continued at a brisk clip, averaging over one per week in 2020. Despite the pandemic the 53 novel drugs approved in 2020 bested 2019’s 48 approvals but fell short of the 59 approved in 2018. In a report on the FDA’s novel drug approvals for 2020, FDA noted that 40%, or 21 of 53 approved drugs, are considered first-in-class. Rare diseases were addressed by 31 of the novel drugs, or 58%.
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Earlier this week, Pfizer partner BioNTech upped the pair’s 2021 COVID-19 output projection to 2 billion doses for 2021, up from a previous estimate of 1.3 billion. But how will the companies get there? By doing things “very differently and very out of the box in manufacturing,” CEO Albert Bourla explained this week during a fireside chat at the J.P. Morgan Healthcare Conference. There are “so many initiatives we have put in place,” Bourla said, including changing the the way it works with partners on raw materials, reimagining its operational flow to improve capacity, designing new equipment—and working with manufacturers to get that new equipment delivered quickly—and more.
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Johnson & Johnson published updated early data on its Covid-19 vaccine this week, showing that it provided participants in a clinical trial with at least some immunity after one dose. The data, published in the New England Journal of Medicine, offer only hints to a tantalizing question: Could the vaccine, given as a single shot, perform as well as the vaccines that U.S. regulators have already authorized, which are given as two? In the study, participants had neutralizing antibodies, measured in a unit called a geometric mean titer, of 224 to 354, on day 29 after their first vaccine dose; those levels reached 288 to 488 by day 57. These levels could be enough to produce immunity.
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EVOQ Therapeutics has announced a license and collaboration agreement with Amgen for the discovery and development of novel drugs for autoimmune disorders. Under the terms of the agreement, Amgen and EVOQ will collaborate on preclinical development and Amgen will be responsible for clinical development and commercialization. In exchange for exclusive rights to selected autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million, as well as pay royalties on sales of resulting therapies. EVOQ’s focus is on autoimmune diseases, although its original intent was targeting oncology. It was spun-off from the University of Michigan in 2016.
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BeiGene will partner with Novartis to develop, manufacture and commercialize its cancer drug tislelizumab. Under terms of the deal, BeiGene will earn $650 million in an upfront cash payment from Novartis, and up to $1.55 billion in milestone payments and royalties on product sales. Novartis will co-develop and commercialize tislelizumab in North America, the European Union, Japan and six other countries, BeiGene said, adding BeiGene would be responsible for funding ongoing clinical trials of tislelizumab. Both parties have freedom to conduct combination trials globally under the deal.
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Abzena has announced the addition of a 6th Global site that will augment cGMP manufacturing capacity for mammalian biologics. This expansion is driven by an increase in customer demand for commercial scale 2000L single use bioreactors across a wide range of therapeutic areas. The new facility will be based in the United States and will accommodate phase 3 and commercial manufacturing.  A phased approach to construction will initially allow 4 modular suites with each suite including up to two 2000L bioreactors, followed by the addition of two further 2000L suites.  Additionally, the site will be equipped to handle existing and new advances in manufacturing such as continuous manufacturing and perfusion with manufacturing commencing in mid-2022.
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Pfizer has announced the investment of $120 million in four clinical-stage biotech companies as part of the Pfizer Breakthrough Growth Initiative (PBGI). Through PBGI, Pfizer is investing up to $500 million in biotechnology companies, providing funding and access to Pfizer’s scientific expertise to help ensure the continuity of promising clinical development programs of potential future strategic interest to Pfizer. Established in June 2020, the Pfizer Breakthrough Growth Initiative focuses on non-controlling equity investments. Recipients of these recent monies include Essa Pharma ($10M), Trillium Therapeutics ($25M), Vedanta Biosciences ($25M) and Homology Medicines ($60M).
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Sanofi has agreed to buy immunotherapy firm Kymab for up to $1.45 billion in cash, the latest in a string of deals as it belatedly expands in a fast-growing medical area. The deal, which will see Sanofi pay $1.1 billion upfront, will give it full rights to Kymab’s KY1005, an antibody therapy viewed as having the potential to treat a wide range of inflammatory disorders and immune-related diseases. KY1005 passed a mid-stage Phase IIa clinical trial in August. The deal price could increase by $350 million based on reaching certain pre-defined milestones. The acquisition is expected to be completed by the end of June.
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Boehringer Ingelheim has signed a collaborative agreement with Google Quantum AI to research and implement quantum computing in pharma research and development. The three-year partnership will see the German pharma combine its expertise in the field of computer-aided drug design and in silico modelling with Google’s resources in quantum computer and algorithm development. In a statement, Boehringer said that quantum computing has the potential to accurately simulate and compare much larger molecules than current computers can identify, creating new opportunities for pharmaceutical R&D in a range of diseases.
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Bluebird Bio plans to split itself in two later this year, spinning off its cancer-drug unit into a new, publicly traded company so it can focus on rare diseases. Bluebird Chief Executive Nick Leschly will helm the new cancer company and assume a new position as executive chairman of Bluebird. Andrew Obenshain, currently Bluebird’s president of severe genetic diseases, will become its chief executive, the company said. The separation is expected to close in the fourth quarter, the company said. The restructuring comes as Bluebird struggles to match its scientific achievements advancing its drug pipeline with commercial success.
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A mutation found in fast-spreading coronavirus variants does not negate the Covid-19 vaccine from Pfizer and BioNTech, researchers are reporting. The result is positive, if expected, evidence that existing vaccines will be able to withstand some mutations to the SARS-CoV-2 coronavirus without losing efficacy. But experts noted that this vaccine and others will still need to be tested against other mutations of concern, and that the new study only looked at one key mutation contained in the variants, not the full variants. “We’re working on that part now” in additional studies, Philip Dormitzer, Pfizer’s vice president and chief scientific officer of viral vaccines, told STAT.
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Neoleukin Therapeutics has made public a recent decision by the U.S. FDA to put a hold on the drug developer’s application to start human trials of its protein-based candidate, NL-201, to treat cancer. The company’s shares tumbled 20.6 after the agency asked the company to develop a new assay that more precisely measures the amount of protein being administered. Despite the clinical hold, Neoleukin is confident in its candidate to move forward. The company’s lead treatment is a cancer immunotherapy, designed to expand cancer-fighting CD8 T-cells and natural killer cells.
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Adverum Biotechnologies will invest $82.8 million for a new gene therapy manufacturing facility in Durham County, North Carolina. The new facility, which will encompass 174,000 square-feet, will include no fewer than four 1,000 liter bioreactors at the outset and be enabled to support future expansion. For its part, the state of North Carolina and local governments have committed up to $9 million in incentives to Adverum which plans to create 200 jobs. According to published reports the new cGMP manufacturing facility will be ready to manufacture commercial product by 2023.
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Fujifilm Corporation is investing more than $2 billion to establish a new large-scale cell culture production site in the U.S. This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. The new site will be built within the vicinity of an existing Fujifilm site, and is scheduled to begin operations in the spring of 2025. Fujifilm Diosynth Biotechnologies will operate the new facility.
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Moderna’s COVID-19 mRNA vaccine is likely to offer protection of up to a couple of years, said company CEO Stephane Bancel this week, even though more data is still needed to make a definitive assessment. “The antibody decay generated by the vaccine in humans goes down very slowly (...) We believe there will be protection potentially for a couple of years.” Given vaccines development and pharmacovigilance usually requires years, the protection duration of COVID-19 shots is a lingering question for scientists and regulators. Bancel added his company was about to prove that its vaccine would also be effective against variants of the coronavirus seen in Britain and South Africa.
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Gilead Sciences’ Kite unit has teamed up with the UK’s Oxford BioTherapeutics (OBT) to develop a new clutch of cell therapy products for solid tumours and blood cancers. The partnership covers up to five oncology targets identified by OBT using its discovery platform, and the UK firm will try to develop antibodies against them. Kite and Gilead will then develop and commercialize therapies based on these targets or antibodies. Under the agreement, OBT will receive an undisclosed upfront payment and may receive additional payments based on the achievement of discovery, clinical, and regulatory milestones, as well as royalties on any sales coming down the line.
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Sartorius Stedim Biotech has entered into an agreement to acquire the chromatography process equipment division of Novasep. The parties agreed not to disclose the purchase price until the necessary regulatory approvals have been obtained. The proposed transaction is subject to antitrust approvals and the information and consultation of Novasep’s works council and is expected to close during the first half of 2021. Novasep’s chromatography unit comprises resin-based batch and intensified chromatography systems. Since 2018, Novasep and Sartorius Stedim Biotech have been collaborating in the joint development of an optimized system for a membrane-based, low-pressure chromatography that will be launched soon.
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Rhythm Pharmaceuticals has agreed to sell a priority review voucher to Alexion for $100 million up front. Rhythm received the transferrable voucher after the U.S. FDA approved the company's chronic weight management drug Imcivree. The voucher is granted if a medicine — in this case, Rhythm's Imcivree — holds the FDA's rare pediatric disease designation at the time of approval; the voucher can then be used to expedite the review of another medicine, shortening the time a drug needs to reach the market. Alexion, which is making the voucher purchase in the midst of an offer from AstraZeneca to acquire the biotech for $39 billion, has not yet revealed which of its medicines will use the voucher.
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Bayer's venture investment arm is leading a $105 million funding round in closely held Senti Biosciences, a company using synthetic biology to develop off-the-shelf cell therapies for cancer. It is at least the third cell therapy company to receive investment from Bayer, which has since acquired one of those companies. Senti is advancing two experimental treatments using "natural killer" immune cells to attack tumors in leukemia and liver cancer. The company believes its technology can create treatments with greater precision and control than current cell therapies. The investment is another sign that Bayer believes the future of cancer cell therapies is in off-the shelf, or "allogeneic," approaches.
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Janet Woodcock, perhaps best known to our community for her longtime leadership of CDER, is now the principal medical advisor to FDA Commissioner Stephen Hahn, according to an internal email obtained first by PULSE. Woodcock stepped aside at CDER in 2020 to join Operation Warp Speed. She will retain the Warp Speed role and remain recused from decision-making surrounding Covid-19 therapeutics, Hahn wrote in the email. For her part, acting CDER director Patrizia Cavazzoni will continue in the role for the foreseeable future. No word yet on what, if any, additional changes might be coming to the FDA amid changes in leadership at Health and Human Services.
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FUJIFILM will invest approximately $40 million in FUJIFILM Diosynth Biotechnologies to establish a new process development and manufacturing facility for viral vectors and advanced therapies in Watertown, Massachusetts. The new facility is scheduled to begin process development operations in fall 2021 and will expand FUJIFILM Diosynth Biotechnologies' manufacturing capacity to support the growing viral vector sector. The new facility will house experimental and analytical equipment for viral vector and advanced therapy process development, with contract manufacturing services for early phase clinical trials beginning at the site in fall 2023.
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Pfizer is dropping the big blue pill for something a bit more… science-y. The pharma giant said this week that it was adopting a new logo to replace the blue, pill-shaped oval that has represented the company since the late 1940s. The new symbol, also in blue, resembles a double helix, the shape of the DNA molecule. The rebranding comes as Pfizer completes a slimming-down that has seen it shed a range of businesses, to focus almost entirely on inventing and buying new drugs. The turn away from the big blue pill also, incidentally, comes months after the company spun off the division that sells Viagra, Pfizer’s “little blue pill.”
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Shanghai Pharma has kicked off the construction of a $1.18 billion biopharmaceutical industry campus. The project will cover 3.2 million square feet constructed in two phases, with 1 million square feet of floor space allocated for the first phase and 2 million square feet for the second. The site will dedicate 538,000 square feet to focus on cutting-edge sectors such as research related to cell and gene therapy. While 861,000 square feet will be allocated for the manufacturing of therapeutics antibodies. According to published reports the latter will involve no fewer than 120,000 liters of bioreactor capacity.
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The last day of 2020 came and went without a decision by the US FDA on approval of a closely watched cancer cell therapy owned by Bristol Myers Squibb. While the FDA's review of the therapy, known as liso-cel and developed for the treatment of late-stage lymphoma, continues, Dec. 31 was a crucial deadline for investors holding a tradable security issued by Bristol Myers as part of its $74 billion acquisition of Celgene two years ago. The security, known as a contingent value right, promised payouts from Bristol Myers if liso-cel and two other drugs formerly owned by the biotech won U.S. approval by certain dates. Were all three to secure FDA backing on time, Bristol Myers pledged to pay those shareholders roughly $6 billion more.
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With a final push that saw the regulator approving its final drug on December 23rd, 2020 the U.S. FDA’s CDER finished the year with 53 approvals for new molecular entities and new therapeutic biological products. Making 2020 one of the agency’s best years for annual approvals. That being said, it should be noted that this count does not include vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products, or other products approved in 2020 by the Center for Biologics Evaluation and Research.
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Eli Lilly will acquire Prevail Therapeutics for up to $1 billion. Under the deal, Eli Lilly will pay roughly $880 million to acquire Prevail, and will pay another $160 million if one of Prevail's drugs is FDA-approved by the end of 2024. The acquisition will help it create a gene therapy program, which will be anchored by Prevail's portfolio of clinical stage and preclinical neurodegenerative disease drugs. The drugs it has in development are designed to treat diseases including Parkinson's and Alzheimer's. The deal is expected to close in the first quarter of 2021.
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Italy’s Angelini Pharma has agreed to buy emerging Swiss biotech company Arvelle Therapeutics for up to $960 million as it aims to become a leading European player in the treatment of the central nervous system and mental illness. Angelini will pay private equity backed Arvelle an initial $610 million in cash and another $350 million following the European Medicines Agency’s approval of a drug for epilepsy treatment, which is expected this year, and certain revenue targets. South Korea’s SK Biopharmaceutical, which owns 12 percent of Arvelle, will receive an advance payment of $ 32 million and an additional $ 22 million in regulatory and sales payments.
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Tonix Pharmaceuticals, a clinical-stage biopharmac company based in Chatham, New Jersey has purchased a 44-acre site in Hamilton, Montana to build a vaccine development and commercial-scale manufacturing facility. The project comes on the heels of Tonix’s purchase of a 40,000-square-foot facility in Massachusetts to house its Advanced Development Center for development and manufacture of vaccines. Both sites are expected to support development and production of Tonix’s vaccine candidates, including potential products for horsepox, COVID-19, smallpox, monkeypox and more. Tonix expects to break ground on the Montana site later this year.
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An influential FDA advisory panel has overwhelmingly backed Moderna’s coronavirus vaccine, a key step paving the way to distribute the second Covid-19 vaccine in the United States next week. The nonbinding decision, which was adopted 20-0 with one abstention, by the FDA’s Vaccines and Related Biological Products Advisory Committee came exactly a week after the outside group of vaccine and infectious disease experts voted to recommend Pfizer and BioNTech’s vaccine for an emergency use authorization, or EUA. The agency granted Pfizer’s EUA the next day, and the first inoculations in the U.S. were given Monday.
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Taysha Gene Therapies will add more than 200 jobs as part of an expansion in RTP announced this week. The company, based in Dallas, chose the Triangle over Dallas, Texas, for a 160,000 square foot facility which will serve as its manufacturing site. It will invest $75 million as part of the expansion. North Carolina’s Economic Investment Committee approved a state benefits package of more than $5 million for the project at a meeting earlier this week. Taysha joins a growing number of companies in the Triangle area focused on gene therapies. The site is expected to be completed and conducting hiring in the next three years.
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Thermo Fisher Scientific has announced the construction of a new cGMP plasmid DNA manufacturing facility in Carlsbad, Calif. The site will expand the company's clinical and commercial capabilities for cGMP plasmid DNA used as a critical raw material to develop and manufacture cell and gene-based therapies including life-saving cancer treatments as well as mRNA vaccines. In addition, the site will have the capability to produce large-scale plasmid DNA as a primary drug substance for DNA therapies. The 67,000-square-foot facility, expected to be completed in the first half of 2021, will feature advanced technologies, including single use equipment with up to 1,000L scale, digital connectivity and data visibility to enable operational efficiencies and operator training.
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The first days of Pfizer’s COVID-19 vaccine rollout have seen unexpected hitches including some vaccines being stored at excessively cold temperatures and Pfizer reporting potential challenges in its vaccine production, U.S. officials said on a press call this week. At least two trays of COVID-19 vaccine doses delivered in California and Alabama needed to be replaced after their storage temperatures dipped below minus 92 degrees Celsius, they are supposed to be kept at around minus 70C. Pfizer also has reported some production issues, U.S. Secretary of Health and Human Services Alex Azar said. Officials did not outline what the specific manufacturing challenges were.
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A Westlake Village venture capital firm has announced it has launched two funds totaling $500 million to invest in promising biotech companies in the greater Los Angeles area, including several in Thousand Oaks. Westlake Village BioPartners has been working with Pasadena-based Alexandria Real Estate Equities to create a three-building, 130,000-square-foot life sciences campus in Thousand Oaks' biotech hub, said Thousand Oaks City Manager Drew Powers. The campus on Rancho Conejo Boulevard includes a 30,000-square-foot laboratory space. According to the venture capital firm, five "early stage" life sciences companies are already in the new "incubator" space in Thousand Oaks' biotech hub and will be joined by three more.
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AbSci is moving its operations into the Columbia Tech Center in east Vancouver. The new headquarters, which AbSci is leasing, will take up about 61,000 square feet at 18105 S.E. Mill Plain Blvd. The company will move out of its current spot in The Hudson Building at 101 E. Sixth St. in April or May of 2021, said AbSci founder and CEO Sean McClain. In October, the company announced it had raised $65 million in investments, with most of the money going toward the company’s expansion which included hiring an additional 100 employees and purchasing new capital equipment, including small fermentation tanks to develop proteins. The expansion “will allow us to quadruple our overall capacity,” said McClain.
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Moderna's Covid-19 vaccine is 94 percent effective at preventing symptomatic illness and appears to prevent the spread of the virus as well, according to documents released this week. The findings set the Moderna vaccine up for emergency use authorization by the FDA later this week, meaning Americans could soon have two highly effective Covid-19 vaccines. The high efficacy of the Moderna vaccine was noted after two doses given 28 days apart. This is about the same level of effectiveness as the Pfizer vaccine. But there is also evidence suggesting that just one dose of Moderna's may stop the virus's spread. A second document published on the FDA website shows asymptomatic infection was reduced by 63 percent after the first shot.
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The US FDA has authorized the first at-home antigen test for COVID-19 that will be available for over-the-counter purchase. The rapid lateral flow test is authorized for use with a nasal swab from individuals at least 2 years old, and it may be used in asymptomatic individuals. In the statement, the FDA noted that emergency use authorizations (EUAs) have also been issued for a prescription test for home use, and for a non-prescription system where a laboratory processes a self-collected sample. More than 25 tests are now available for home sample collection, though all but the newly authorized Ellume home test require that the test be sent to a lab for testing.
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The United States has a Covid-19 vaccine, the result of science carried out at breakneck speed. Now, whether the country knows it or not, it’s awaiting the results of another whirlwind effort: one to come up with brand names for products that will literally change the world. Naming a vaccine is almost always a matter of threading semantic needles, branding experts said, where the goal is to evoke positive vibes without irking the world’s ever more conservative regulatory bodies. And it takes time. The process of christening a new medicine typically involves about two years of semiotic labor. But in 2020, the naming process has been condensed into a six-month sprint.
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Harbour BioMed, and Utrecht University have announced that they licensed to AbbVie their fully human, SARS-CoV-2 neutralizing antibody, 47D11 and program, for the prevention and treatment of COVID-19 and related coronaviruses, and that AbbVie has initiated a Phase 1 clinical trial of the antibody. AbbVie will initially conduct the initial clinical program in the U.S. and expand it into Europe. The license agreement will help advance the development of ABBV-47D11, which in pre-clinical research, demonstrated potential against SARS-CoV-2, as well as a related virus, SARS-CoV-1. Under the license agreement, AbbVie will conduct clinical development of ABBV-47D11, and if successful, will manufacture and commercialize the product worldwide.
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The U.S. can buy a Covid insurance policy for next year. The federal government should scale up production of antibody drugs to make as many doses as possible. The Food and Drug Administration has cleared two such drugs, from Regeneron and Eli Lilly, for emergency use. For newly diagnosed patients, they reduce the risk of severe disease. Making them is relatively straightforward, but supply is limited because the government didn’t find enough manufacturing space in the spring. Regeneron and Lilly took extraordinary steps to increase their own production. These thoughts and more are shared by former FDA Commissioner Scott Gottlieb this week in the Wall Street Journal.
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Viatris, the generic drug company created through Mylan's merger with Pfizer's Upjohn unit, says it plans to close or divest up to 15 manufacturing plants worldwide as part of a major cutback that could impact as many as 9,000 employees. Among the plants being shuttered is a sprawling, former Mylan factory in Morgantown, West Virginia that produces pills and tablets. Operations will close down by mid-2021, a company spokesperson confirmed to BioPharma Dive, noting that "a majority of employees impacted" will remain working until then. Viatris will keep open, however, a research and development center in Morgantown, the spokesperson said. Other facilities being closed, sold or downsized include "oral solid dose" plants in Baldoyle, Ireland and Caguas, Puerto Rico, as well as two drug ingredient facilities in India.
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In the biggest biopharma deal this year, AstraZeneca has agreed to acquire Alexion Pharmaceuticals for $39 billion. The deal, which is expected to close sometime between July and September, would have AstraZeneca hand over $60 in cash and roughly 2.1 American Depositary Shares — each one-half the value of an ordinary AstraZeneca share — for every share of Alexion. Using an average price of $54.14 per ADR, the deal implies a value of $175 for each Alexion share. Founded in the early 1990s, Alexion has five marketed products, including one from its recent buyout of Portola Pharmaceuticals. Acquiring Alexion helps to diversify AstraZeneca, which has been growing mostly because of newer drugs for cancer and diabetes.
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One of the world’s leading vaccine manufacturers has suffered a major setback in its work to produce a Covid-19 vaccine. The problem will push the timeline for deployment of Sanofi Pasteur’s vaccine — if it is approved — from the first half of 2021 into the second half of the year. Sanofi had hoped to start a Phase 3 trial of the vaccine this month and had projected it could produce 100 million doses of vaccine in 2020, and 1 billion doses in 2021. The problem relates to inadequate results in older adults in Sanofi’s Phase 1/2 trial, which the company traced back to an inadequate formulation of their vaccine, Su-Peing Ng, global medical head for Sanofi Vaccines, told STAT in an interview.
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US drug giant MSD has announced plans to create 240 jobs as it builds a new research facility next to a biologics medicines plant it acquired in Dunboyne, Co Meath earlier this year. MSD agreed to buy the former Takeda plant in Dunboyne in August. It had been the last major investment made by rival pharma company Shire before it was acquired by Takeda in 2019. The company had invested $455 million (€375 million) in the operation on a 120-acre site outside the town. The new plant, which will be built alongside the existing manufacturing facility, is expected to be ready for use by the end of 2023 and MSD expects to employ 140 people there by 2025.
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Pfizer’s Covid-19 vaccine passed a critical milestone this week when a panel of experts formally recommended that the FDA authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week. The FDA’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the FDA follows the advice of its advisory panels. An EUA is expected to be granted this weekend according to people familiar with the agency’s planning.
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Boehringer Ingelheim is paying $1.5 billion (1.18 billion euros) for Swiss-based NBE Therapeutics, the German drugmaker announced this week, adding pipeline candidates including a drug in early trials against triple-negative breast cancer and lung cancer. NBE, in which Boehringer’s venture fund previously had a stake along with the Novo Nordisk Foundation and PPF Group, is hoping to develop so-called Antibody-drug Conjugates (ADCs) from its own platform against a series of cancers. The deal is a bet on the future, with the triple negative breast cancer hopeful, called NBE-002, only having just started human trials, and four other candidates either in discovery or preclinical stages.
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Gilead has agreed to acquire the German drugmaker Myr Pharmaceuticals and its marketed therapy for chronic hepatitis D, also known as delta hepatitis, in a deal worth a little over $1 billion. The Myr acquisition catapults Gilead to the front of the hepatitis D market, as Hepcludex is currently the first and only medicine conditionally approved by the EMA to treat the infection. Terms of the deal require Gilead to pay about 1.15 billion euros, or roughly $1.4 billion, in cash up front. The biotech has also agreed to pay Myr up to 300 million euros, dependent on Hepcludex securing approval in the U.S.
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The FDA has found that there are "no specific safety concerns" that would stop the agency from approving the COVID-19 vaccine made by Pfizer and BioNTech for emergency use. The FDA's findings come in documents posted this week and served as a prelude to a meeting of independent experts later today to advise the FDA on whether to approve the vaccine. An analysis by the FDA found the vaccine to be 95% effective — affirming Pfizer's findings. Commissioner Hahn talked with NPR's All Things Considered about where the vaccine approval process goes from here.
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German biotech firm BioNTech said this week that documents relating to the Covid-19 vaccine it has developed with Pfizer were “unlawfully accessed” after a cyber-attack on Europe’s medicines regulator. Earlier, the European Medicines Agency (EMA) – which is responsible for assessing and approving vaccines for the European Union – said it had been targeted in a cyber-attack. It gave no further details. It was not immediately clear when or how the attack took place, who was responsible or what other information may have been compromised. Britain’s National Cyber Security Centre said it was studying the situation and its impact on the UK, the first country where the Pfizer/BioNTech vaccine has been deployed.
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Sartorius Stedim Biotech has announced the acquisition of WaterSep BioSeparations, perhaps best known to our industry for its hollow-fiber membrane devices and pre-sterilized assemblies for upstream and downstream biopharmaceutical applications. The privately-owned company based in Marlborough, Massachusetts employs around 15 people and is expected to earn revenue of approximately 2.5 million U.S. dollars in 2020 at strong growth rates and a substantial double-digit EBITDA margin. The parties agreed on a purchase price of approximately 27 million U.S. dollars plus an earn-out component of up to 9 million U.S. dollars, depending on the achievement of defined sales revenue growth by 2023.
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The FDA concluded in a detailed analysis that the first Covid-19 vaccine being considered for U.S. distribution “met the prescribed success criteria” in a clinical study, paving the way for the agency to green-light distribution as early as this weekend. An outside panel of scientific advisers will review the FDA report this Thursday, along with a companion analysis from the vaccine’s manufacturers, Pfizer and German partner BioNTech. A favorable recommendation from the panel is expected to be followed within a few days by the FDA granting emergency authorization for the vaccine.
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