News Alert

A team of CRISPR scientists at the New York Genome Center, New York University and Icahn School of Medicine at Mount Sinai say they have identified the genes that can protect human cells against Covid-19, a disease that has infected over 40 million and led to 1 million deaths worldwide. The discovery comes after an eight-month screen of all 20,000 genes in the human genome led by Dr. Neville Sanjana at the New York Genome Center. Leading virologist at Mount Sinai, Dr. Benjamin tenOever, developed a series of human lung cell models for the coronavirus screening to better understand immune responses to the disease and co-authored the study. Their study, published online by Cell, will appear in the scientific peer-reviewed journal’s January 7th print issue.
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Five federal agencies have started telling employees they could receive Pfizer or Moderna’s Covid-19 vaccine in as little as eight weeks as the U.S. prepares to distribute the potentially life-saving doses across the country, according to a person with first-hand knowledge of the plan. Essential federal workers would be among the first group of Americans to get inoculated against the coronavirus after the nation’s health-care workers, according to the CDC’s vaccination program “interim playbook.” The plan lists essential workers, along with the elderly and other highly vulnerable groups, in the first phase of its vaccine distribution plan, which hasn’t been finalized yet and could change.
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Real estate investment group IQHQ has raised $1.7 billion in equity capital to build unparalleled life science cities in major U.S. and UK markets, including San Diego. Formed a year ago, IQHQ is the brainchild of longtime life science builder Alan Gold, who founded BioMed Realty Trust and sold it to Blackstone Group in a transaction valued at $8 billion. The 35-person firm is primarily based in San Diego with 80 percent of the team working out of IQHQ’s Solana Beach office. The $1.7-billion round trails by just nine months the group’s first raise of $770 million, bringing total funding to nearly $2.5 billion. Investors include new and repeat investment from pension funds, sovereign funds, dedicated REIT investors and large family offices.
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News that Pfizer-BioNTech’s vaccine needs to be at –70 °C, which is best done with dry ice, has raised awareness of a new challenge. Dry ice is made by compressing and cooling liquid carbon dioxide. It accounts for about 20% of US demand for CO2. The trouble is, CO2 is in short supply. Most CO2 in the US is captured from ethanol and ammonia production, both of which are down right now due to depressed ammonia prices in the US. On top of that, demand for dry ice is already up because of an increase in home delivery of frozen groceries. As a result, scientists and businesses that rely on dry ice or other forms of CO2 are being urged to get their orders in soon and plan for longer wait times.
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Samsung Biologics recently gave up developing SAIT101, a biosimilar of follicular lymphoma treatment Rituxan, which it had promoted as its first product since entering the bio business. According to the Samsung Biologics’ quarterly report released this week, the company and AstraZeneca, decided in September to suspend research and development activities by their joint venture, Archigen Biotech, and liquidate the latter. The two companies had set up the tie-up firm to focus on developing only the anticancer drug. Samsung Biologics has invested about $126 million into Archigen Biotech since its founding.
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Samsung Biologics has officially begun construction of its Plant 4 in Incheon, South Korea. Dubbed the "Super Plant," the new, multi-story 2.5 million sq. ft. construction will be the world's largest biopharmaceutical manufacturing facility of its kind boasting 256,000 liters total manufacturing capacity. Upon completion of Plant 4, Samsung Biologics is expected to be accountable for a third of the total global bio-CMO manufacturing capacity, offering a combined sum of 620,000 liters from a single site. Plant 4 also features a modular design that will allow flexibility for certain parts of the plant to begin manufacturing activities by the end of 2022, with the goal to commence full operations in 2023.
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Pfizer and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said this week. The vaccine’s efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people. “If all goes well, I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” said BioNTech CEO Ugur Sahin.
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Celltrion has unveiled plans to build its third plant and a global biotechnology research center in Songdo, Incheon, during the Korea Bio-industry forum this week. The company will build a 60,000-liter biopharmaceutical plant to build a multi-type production and supply system and a one-stop research center for complex R&D, process development, and clinical practice. This proposed factory will install a total of eight 7,500-liter bioreactors, as the company is set to respond flexibly to the production of its biopharmaceuticals as its portfolio widens. Timing for the project has the  research center being completed in July 2022 and the third plant in May 2023. The third plant will start operation from June 2024.
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When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr. Barney Graham, then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic. Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by Graham and his colleagues, a concept that emerged from a scientific quest to understand a disastrous 1966 vaccine trial. Basic research conducted by Graham and others at the National Institutes of Health, Defense Department and federally funded academic laboratories has been the essential ingredient in the rapid development of vaccines in response to COVID-19.
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The CEO of BIO warned this week that the industry could sue to try to stop a proposal from the Trump administration to lower drug prices. The Trump administration could move forward as soon as this week on a proposal to lower certain Medicare drug prices by tying them to lower prices paid in other wealthy countries, an idea fiercely opposed by drug companies, which are now mobilizing both to try to stop the rule and plan for a fight if it does go forward. “I would say all tools would be at our disposal because it would just have such a devastating impact on our ability to bring new cures for patients,” Michelle McMurry-Heath told The Hill on Tuesday. 
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The U.S. FDA has handed Alkermes another setback, citing manufacturing issues in refusing to approve the company's new schizophrenia medicine. Alkermes emphasized the agency raised no issues with data in the company's application for the drug, known as ALKS 3831, and hasn't requested any new studies. The FDA singled out tablet coating problems with specific development batches of the drug that have since been resolved, the company said. Data are available to address the FDA concerns, and the company is preparing a submission for regulators, Alkermes said. Chief Medical Officer Craig Hopkinson added the company sees "a clear path to resolution”.
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Bristol Myers Squibb announced this week that the U.S. FDA has deferred a decision on an experimental blood cancer therapy that it acquired in the $74 billion buyout of Celgene due to coronavirus-related travel restrictions. This comes after the FDA  was unable to inspect a third-party manufacturing facility in Texas, a step required before the approval of the drug liso-cel, the company said. The health regulator warned earlier this year its level of timely reviews and approvals of marketing applications could be impacted by the COVID-19 crisis. The agency’s approval of liso-cel by Dec. 31, 2020, is one of the remaining milestones required for Celgene investors to receive a conditional payment of $9 per share.
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An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group this week. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers. The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%. The findings are statistically significant, meaning they are likely not due to chance.
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Lonza's sites in the United States and Switzerland are due to make ingredients for 400 million doses of Moderna's COVID-19 vaccine annually. This announcement comes after Moderna said its vaccine candidate showed 94.5% efficacy, according to interim data. Basel-based Lonza is building four production lines -- one in Portsmouth, New Hampshire, and three in Visp deep in the Swiss Alps -- for $60-70 million each, with each line capable of producing 100 million doses. Lonza has previously said it could potentially increase production capacity for Moderna’s vaccine, including at a site in Singapore or in Switzerland, although a spokesperson says the company is initially focused on completing the four production lines now in the works.
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Miltenyi Biotec says that it has fully restored systems after a malware attack that took place last month and affected the firm's global IT infrastructure. "During the last two weeks, there have been isolated cases where order processing was impaired by malware in parts of our global IT infrastructure," Miltenyi Biotec said in an official statement. "Rest assured, all necessary measures have now been taken to contain the issue and recover all affected systems. Based on our current knowledge, we have no indication that the malware has been inadvertently distributed to customers or partners." At the moment, the company said that it has successfully restored all operational processes impacted in last month's malware attack.
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The Australian government has concluded a $1 billion agreement, funded over 12 years, with Seqirus to secure supply from a new high-tech manufacturing facility in Melbourne which would produce pandemic influenza vaccines as well as antivenoms. Seqirus, a subsidiary of CSL Ltd, will invest $800 million in the facility, which will be built at Tullamarine, near Melbourne airport. The Victorian government has supported the procurement of the land for the new operation. Work on construction will begin next year; the project will provide some 520 construction jobs. The facility is due to be fully operating by 2026, with the contract for supply of its products running to 2036.
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California voters have again backed spending billions of dollars for stem cell research with the approval of a ballot measure. The initiative, Proposition 14, had been narrowly leading since Election Day; the Associated Press called the result Thursday night, with about 51% of voters in support. The measure authorizes the state to issue $5.5 billion in bonds to fund stem cell research. With interest, it’s expected to cost nearly $8 billion over time. The money will be doled out by the California Institute for Regenerative Medicine, known as CIRM, which was created after voters in the state initially approved a bond measure for stem cell research in 2004.
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In a multi-year investigation surrounding Sanofi’s epilepsy drug Depakine, the charges now include France’s medicine watchdog, the National Agency for the Safety of Medicines and Health Products (ANSM). The ANSM was indicted for “negligent injuries and manslaughter” in the Depakine case. The drug, sodium valproate, has been on the market since 1967 to treat epilepsy, migraines and bipolar disorder and is prescribed in over 100 countries. When the EMA re-evaluated the drug in 2014, it put out strong recommendations that it should not be prescribed to women of child-bearing age. But for the thousands of families already affected, this was far too late.
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Pfizer's new form of COVID-19 vaccine is expected to arrive in 2021, and it will be in a powder form. This innovation could help solve one of the biggest limitations of COVID-19 vaccines, which is the need for freezing refrigeration. According to Business Insider's latest report, the company is already working on a new coronavirus vaccine that could get around its problem of needing to be kept in extremely cold temperatures. "For the COVID-19 disease, I think we'll roll out next year a vaccine in powder format," Pfizer's chief scientist, Mikael Dolsten, told Business Insider. Although Pfizer's chief scientific officer did not specify the exact temperature needed, he claimed that the new vaccine form will only require standard refrigeration. Learn More

The US FDA is quietly putting together plans for a pilot program that will allow agency investigators to conduct facility inspections virtually as the COVID-19 pandemic rages on. So says longtime industry expert Steve Niedelman, who’s lead quality systems and compliance consultant at the law firm King & Spalding.“ The FDA paused inspections in March at manufacturing facilities in the US and abroad. Eric Henry, King & Spalding’s senior quality systems and compliance advisor, pointed out that notified bodies overseas are already using FaceTime and other video platforms to conduct virtual facility walkthroughs. Learn More

Beckman Coulter Life Sciences signed a definitive agreement to acquire m2p-labs, a privately held, microbioreactor manufacturer based in Baesweiler, Germany. m2p-labs is best known for its BioLector plate-based microbioreactors, which support automated solutions for screening and bioprocess development. m2p-labs associates and products will transition into Beckman Coulter Life Sciences’ Biotechnology Business Unit. The company’s existing Baesweiler, Germany site will remain operational. The financial details of the deal have not been made public as of the time of this writing. Learn More

Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, this week said it would be challenging to distribute vaccines that use messenger RNA based technology in developing countries, owing to their cold storage requirements. The comments come days after Pfizer Inc said its experimental COVID-19 vaccine is more than 90% effective based on initial trial results and that it expects to file for U.S. emergency authorization this month. The vaccine candidate uses synthetic messenger RNA to activate the immune system against the virus and needs to be kept at minus 70 degrees Celsius (-94 F) or below. Learn More

After months of urging the public to wear masks and facial coverings to help stop infected people from spreading COVID-19, the Centers for Disease Control and Prevention (CDC) now states in newly released guidance that masks also protected the mask wearer from being infected. This is perhaps the strongest endorsement the agency has made about masks to date. In the guidance report, the CDC adds the adoption of universal masking policies can help prevent future lockdowns “especially if combined with other non-pharmaceutical interventions such as social distancing, hand hygiene, and adequate ventilation." Learn More

Where the “gun that won the West” was once manufactured, a venture capital–funded drug discovery company has leased 9,800 square feet of laboratory and office space. The six-story life science building at 115 Munson Street, acquired 12 months ago by a joint venture of Twining Properties, L+M Development Partners and the Goldman Sachs Urban Investment Group, is in the Winchester Center technology and life sciences campus. Halda Therapeutics, a biotech founded from Yale University, completed a $25 million funding round in 2019. The company plans to relocate to New Haven in Q1’ 2021. Learn More

Pfizer and Moderna are both 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. Whether mRNA vaccines succeed or not, their path from a gleam in a scientist’s eye to the brink of government approval has been a tale of personal perseverance, eureka moments in the lab and soaring expectations. Learn More

Health and Human Services (HHS) Secretary Alex Azar this week said the government expects to have enough doses of a coronavirus vaccine for all Americans by the spring, an announcement that comes after promising announcements from Pfizer and Eli Lilly. The government anticipates having enough doses by the end of December to vaccinate high-risk people, enough for all first responders and healthcare workers by the end of January and to vaccinate all Americans by the end of March to early April, Azar said. Although Pfizer’s drug is still yet to be approved, Azar said the company would deliver 20 million doses to the government each month starting at the end of November. Learn More

Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, has signed a 10 year lease on 138,000 square feet at 200 West Street in Waltham, Massachusetts. The site, currently being redeveloped by BXP into lab space, is expected to be completed in 2021. 200 West Street features a variety of modern lab spaces, including cold rooms and pilot labs, as well as chemistry and biology labs. The redevelopment site also features an additional roughly 130,000 square feet of developable life science space. With this deal Translate Bio joins a growing list of leading biotech’s that call Waltham home. Learn More

Pfizer and partner BioNTech have announced that their vaccine against Covid-19 was strongly effective, exceeding expectations with results that are likely to be met with cautious excitement, and relief, in the face of the global pandemic. The vaccine is the first to be tested in the United States to generate late-stage data. The companies said an early analysis of the results showed that individuals who received two injections of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic Covid-19 than those who received a placebo. For months, researchers have cautioned that a vaccine that might only be 60% or 70% effective. The Phase 3 study is ongoing and additional data could affect results. Learn More

Ultragenyx Pharmaceuticals has announced that it plans to build a new large-scale gene therapy manufacturing facility in Bedford, Massachusetts. The planned Phase I facility will encompass 100,000 square feet and provide important internal capacity to develop and manufacture supply of Ultragenyx’s gene therapies for both clinical stage and approved products. The facility will be able to support two independent manufacturing suites with a capacity of 30 runs per year. Construction of the new facility has begun and is expected to be complete in 2023. Ultragenyx already controls land and development rights for an additional 86,000 square feet of Phase II expansion on-site which could be used to double capacity if needed. Learn More

New England Biolabs® (NEB®) has selected ABEC to expand production capacity at their manufacturing facilities in Ipswich and Rowley, MA. NEB, an international leader in the discovery and production of recombinant proteins for molecular biology applications, will utilize multiple customized stainless-steel fermenters for high-density Escherichia coli fermentation. With expected delivery of the ABEC 400L and 1000L fermenters by mid-2021, the expansion will enable NEB to continue to increase their product offerings. ABEC’s extensive experience, complete in-house capabilities, and long-term credibility will ensure NEB’s ongoing ability to manufacture high-quality products with proven lot-to-lot consistency. Learn More

While the rest of the country has been counting votes, an Army general named Gus Perna has been counting doses of vaccine. He is in charge of Operation Warp Speed, the catchy title given to the crash program to inoculate 300 million Americans against the coronavirus by next spring. For those of you longing to reclaim a semblance of your previous life, it may not seem all that speedy, but it is compared to the five to ten years it usually takes to field a new vaccine. Once approved, it will not be a silver bullet. Just as with the annual flu shot, some of us will still get sick. But it should make enough people immune so that the virus runs out of places to go. That would give this country what it badly needs right now – a shot in the arm. Learn More

A panel of outside advisers to the U.S. FDA on Friday voted that a potential Alzheimer’s treatment from Biogen Inc has not been proven to slow progression of the disease, a sharp rebuke to agency staff who earlier this week praised the drug. The FDA still could decide to approve the drug, aducanumab, making it the first new Alzheimer’s treatment in decades. But the group of scientific advisers made their doubts about the treatment clear. Several of the 11 panel members expressed resentment that the FDA’s early view of aducanumab was biased toward a favorable outcome for Biogen. The FDA is expected to make its decision on the drug by March.
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Emisphere Technologies has announced that it has entered into a definitive agreement with Novo Nordisk, whereby Novo Nordisk will acquire Emisphere for $1.35 billion in cash. Novo Nordisk and Emisphere have collaborated since 2007, on Emisphere’s proprietary drug delivery technology Eligen®, which facilitates the enhanced oral absorption of molecules without altering their chemical form, biological integrity or pharmacological properties. Novo Nordisk is currently utilizing Emisphere’s carrier technology under an existing license agreement in its oral formulation of a GLP-1 receptor. Learn More

Merck, known as MSD outside the United States and Canada, and VelosBio have announced that the companies have entered into a definitive agreement pursuant to which Merck, through a subsidiary, will acquire all outstanding shares of VelosBio for $2.75 billion in cash, subject to certain customary adjustments. VelosBio is a privately held clinical-stage biopharmaceutical company committed to developing first-in-class cancer therapies. VelosBio’s lead investigational candidate is VLS-101, an antibody-drug conjugate (ADC) that is currently being evaluated in a Phase 1 and a Phase 2 clinical trial for the treatment of patients with hematologic malignancies and solid tumors. Learn More

Bluebird Bio has confirmed its general agreement with the US FDA that the clinical data package required to support the Biologics License Application (BLA) will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. But the company said that the FDA had also requested the use of drug product manufactured from sickle cell disease patient cells in addition to healthy donors, as well as commercial lentiviral vector, to demonstrate drug product comparability. “Given this feedback, alongside COVID-19 related shifts and contract manufacturing organization COVID-19 impacts, bluebird is adjusting its submission timing to late 2022.” Learn More

In 2009 the flu strain H1N1, known as the swine flu, emerged unexpectedly, resulting in dealys in vaccine availability. This resulted in the CDC having to prioritize dosing, in the case of H1N1 it was determined that, in an effort to minimize deaths, the best approach was to vaccinate those between 6 months and 24 years as young people were understood to be more susceptible. Now, with the emergence of COVID-19 and the lack of adequate vaccines with which to dose everyone the question is once again, who should get vaccinated first. The science says it should be children and adults between the ages of 20 and 50 as they are the high transmission groups in this case. Raising ethical questions that promise no easy answers. Learn More

Biogen has shown “exceptionally persuasive” evidence that its experimental Alzheimer’s disease drug is effective, U.S. FDA staff said this week, elevating its chances of a swift approval and sending company shares soaring. The agency’s documents were released ahead of a meeting on Friday of outside experts who will review, and decide whether to recommend approval of, aducanumab, an antibody designed to remove amyloid plaques from the brain. An FDA approval could come by March, which would make the drug, aducanumab, the first new treatment for the disease in decades and the first that appears to be able to slow progression of the fatal, mind-wasting condition that affects millions of people. Learn More

After a five-year effort, the National Institute of Health late last week released its final policy for managing and sharing publicly funded scientific data. But some critics say the approach falls short, because the language may still make it possible for researchers to withhold their data. The new policy, which replaces one issued in 2003, reflects an ongoing push for transparency by academics and scientists who maintain that, without access to scientific data, research cannot be easily replicated. For this reason, they have argued a lack of information inhibits greater scientific understanding that can adversely affect research decisions and, eventually, treatments and health care costs. Learn More

Eighteen months ago, a small vaccine maker called Novavax faced an existential threat: delisting by the NASDAQ stock index. On the heels of a second failed vaccine trial in less than 3 years, the firm’s shares had plunged to less than $1 for 30 straight days, triggering a warning by NASDAQ. Frantic to conserve cash, the company sold its two Maryland manufacturing facilities, slicing its payroll by more than 100 employees. By January, it employed only 166 people. What a difference a year—and a pandemic—make. Today, Novavax is slated to receive up to $2 billion from the U.S. government and a nonprofit organization to develop and manufacture a coronavirus vaccine. Learn More

Pfizer is set to invest roughly $350cmillion in its three Irish manufacturing sites in Ringaskiddy, Dublin and Kildare. The investment will provide additional manufacturing and laboratory capacity, creating 300 roles over the next two to three years. The roles being created comprise a wide array of highly skilled positions such as engineers, scientists, technicians, and chemists. Part of this investment will allow the construction of a site at Ringaskiddy to manufacture pharmaceutical compounds for the company’s clinical trials across the globe. It will also mark the shift from manufacturing to support the earlier phases of medicine development. Learn More

U.S. health experts this week will decide whether to recommend approval for Biogen’s Alzheimer's drug, which could become the first new treatment for the mind-wasting disease in decades even as serious questions persist over whether data show if it works. In a field littered with unrelenting failure, Biogen believes in aducanumab it has the first drug that can treat an underlying cause, and therefore slow progression, of Alzheimer’s. But its path to approval has been anything but smooth or assured. A committee of outside advisers to the FDA will discuss aducanumab this Friday. The agency’s final decision is expected by March. European health regulators have also accepted the drug for review. Learn More

An experimental psoriasis drug developed by Bristol Myers Squibb outperformed Amgen's approved treatment Otezla in a late-stage study, according to summary results disclosed by Bristol Myers this week. Treatment with a once daily dose of Bristol Myers drug, dubbed deucravacitinib, led to substantially clearer skin in more psoriasis patients than did either placebo or Otezla. Both deucravacitinib and Otezla are taken orally, an advantage in a market mostly made up of injectable medicines. While more detailed data are needed, the trial's outcome likely signals future competition for Otezla, which Celgene was forced to sell last year to win regulators' approval for its acquisition by Bristol Myers. Learn More

Novavax has announced the expansion of its Maryland campus to accommodate the company’s rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. The company has entered into a 15-year lease for approximately 122,000 square feet located at 700 Quince Orchard Road, Gaithersburg, to be used for manufacturing, research and development, and offices. Novavax says it will immediately invest in the buildout of the site to prepare for use beginning in early 2021. In addition, a company affiliate has purchased a 9.7-acre parcel of land at 14 Firstfield Road, Gaithersburg, that the Company plans to develop in the future. Learn More

CureVac’s experimental COVID-19 vaccine triggered an immune response in humans, the German biotech firm said this week, putting it on track to start mass testing this year as the race to end the pandemic heats up. The biotech firm is using the so-called messenger RNA (mRNA) approach, the same as Moderna as well as BioNTech and its partner Pfizer, although they started mass testing on humans in late July. CureVac said its potential vaccine, known as CVnCoV, was generally well tolerated and trial results strongly supported the company’s plans to launch the final stage of testing involving about 30,000 participants before the end of the year. Learn More

Sanofi has entered into a deal to buy Kiadis, a clinical-stage biopharma company developing innovative ‘off the shelf’ natural killer (NK) cells. Under the agreement, Sanofi will acquire Kiadis for roughly $350 million. NK cells seek and identify malignant cancer cells and have broad application across various tumor types. According to Sanofi, Kiadis' platform has the potential to “make products rapidly and economically available for a broad patient population across a wide range of indications”. Sanofi had already licensed Kiadis' K-NK004 preclinical programme for multiple myeloma before this deal. Learn More

On a late August day in an industrial corner of Baltimore that had been mostly silenced by the pandemic, a red-brick manufacturing plant was buzzing with activity. Deep in the building, in a zone called Area 3, the stainless-steel shell of a bioreactor lay on its side, having just arrived from Massachusetts. Employees had begun the task of making the bioreactor operational. Within weeks it would be the center of a production line for coronavirus vaccines. When the owner of the plant, Emergent BioSolutions, ordered the bioreactor, one supplier said some critical parts wouldn’t arrive until November or December. And so Emergent enlisted the help of Operation Warp Speed, officials from which called the supplier to say the order couldn’t wait, throwing the weight of the government behind the request.
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Novartis has announced the receipt of marketing authorization from Japan’s Ministry of Health, Labor and Welfare for Foundation for Biomedical Research and Innovation at Kobe to manufacture and supply commercial Kymriah® (tisagenlecleucel) for patients in Japan. This approval makes it the first and only approved commercial manufacturing site for CAR-T cell therapy in Asia. Novartis has the largest geographical CAR-T cell therapy manufacturing network in the world, including seven CAR-T manufacturing facilities, across four continents. Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US FDA recently approved a further increase in manufacturing capacity. Learn More

Bellicum Pharmaceuticals has announced that interim data from its BPX-601 dose-escalation clinical trial failed to meet meaningful efficacy. After an extensive review of its organization and programs, the company has implemented a restructuring plan, including a reduction in staff, to focus its efforts on its clinical GoCAR-T® product candidates. Under the restructuring program, the company will focus on the clinical development of BPX-601 and BPX-603, pause the BCMA GoCAR-NK program, and discontinue discovery research and new product development. Staff will be reduced by 79%, from 68 to 14 full-time employees by the end of 2020.
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Regeneron was once again ranked as the top company to work for by Science magazine in its annual Top Employers Survey of the global biotech and pharmaceutical industry. The biopharma industry leader has placed either first or second for the past ten years, making it the most highly ranked company of the decade. This year, Regeneron placed first based on more than 7,650 responses from people across the industry and stood out with particularly high marks on measures of innovation, being socially responsible and loyal employees. Learn More

Vedere Bio, a stealth-stage company focused on restoring functional vision, has been acquired by Novartis for $150 million upfront and will be eligible for up to $130 million in milestone payments, bringing the potential total value to $280 million. Based on technology from the laboratories of Drs. Ehud Isacoff and John G. Flannery of UC Berkeley, and technology directed at enhanced ocular gene therapy delivery arising jointly between UC Berkeley and the School of Veterinary Medicine at the University of Pennsylvania, Vedere Bio was formed in the Atlas Venture incubator in June 2019. Learn More

The Trump administration will require most private health plans to cover an approved coronavirus vaccine and its administration with no cost-sharing once the shot is recommended by a Centers for Disease Control and Prevention panel. Medicare will also cover any vaccine at no cost to beneficiaries, while Medicaid will reimburse vaccination with no cost sharing for most plan members through the public health emergency declaration in the U.S. Providers administering the vaccine to people without insurance will be reimbursed by the federal government and are prohibited from charging consumers if they receive the vaccine from the government, according to an interim final rule published this week. Learn More

Amgen's sales and earnings beat Wall Street forecasts for the biotech's September quarter. A driver of the sales beat was the company's success with its biosimilar versions of other biotech firms' blockbusters. Total revenue grew 12% to $6.4 billon, the company said late Wednesday, while earnings per share grew 19%. Sales of Amgevita, the company's version of the AbbVie blockbuster Humira-grew 31% year-over-year, to $80 million. The Amgen biosimilar is the most-prescribed knockoff of Humira in Europe. Like Pfizer, Amgen is trying to make offense the best defense: countering biosimilar competition of its proprietary products by making biosimilars itself. Learn More

In this article, presented as a transcript of a recorded available to be played, NPR's Pien Huang talks to host Ari Shapiro about how coronavirus several of the vaccines in development have strict storage requirements, including being kept at very cold temperatures. In the case of the Pfizer vaccine the required storage temperature is -70 degrees Celsius, roughly the temperature of dry ice. While the Moderna vaccine requires storage at -20 degrees Celsius, roughly comparable to a freezer at home. NPR discusses how the vaccines might be distributed and allocated when they are ready. Learn More

Bayer has announced Dr. Christian Rommel as the new Head of Research and Development at its Pharmaceuticals Division, effective February 1, 2021. Prior to joining Bayer, he held the role of Senior Vice President, Global Head of Oncology Research and Early Development at Roche in Basel. Christian Rommel's prior positions include executive-level R&D roles at Amgen, Intellikine as well as scientific leadership positions at Merck Serono and Regeneron. He succeeds Dr. Joerg Moeller who decided to leave Bayer, effective December 31, 2020, to pursue other career opportunities. Learn More

Repligen has entered into a definitive agreement to acquire privately held ARTeSYN Biosolutions for approximately $200 million, comprised of approximately $130 million in cash and approximately $70 million in Repligen common stock. ARTeSYN Biosolutions is projected to generate approximately $30 million in revenue (pro forma) in 2020, led by the success of its single-use chromatography and filtration systems which are considered the gold standards in downstream bioprocessing due to their performance, automation and low hold-up volumes. The proposed acquisition of ARTeSYN, combined with the recent acquisitions of Engineered Molding Technologies and Non-Metallic Solutions further establishes Repligen as a premier player in single-use systems and associated integrated flow path assemblies. Learn More

One way to fight COVID-19 is with drugs that directly target SARS-CoV-2, the novel coronavirus that causes the disease. That's the strategy employed by remdesivir, the only antiviral drug currently authorized by the U.S. FDA to treat COVID-19. Another promising strategy is drugs that target the proteins within human cells that the virus needs to infect, multiply, and spread. With the aim of developing such protein-targeted antiviral drugs, a large, international team of researchers, funded in part by the NIH, has precisely and exhaustively mapped all of the interactions that take place between SARS-CoV-2 proteins and the human proteins found within infected host cells. Learn More

Initial public offerings are the lifeblood of the biotech industry. Stock listings give young companies access to the vast amount of cash necessary to advance their drugs through clinical development, and their venture backers a crucial opportunity to earn a return and form new biotech's. But a lucrative IPO doesn't mean the company will thrive. Biopharma Dive is tracking details of these IPOs in a database which they intend to update regularly. U.S. biotech IPOs of $50 million or higher from the past three years are included, and they will add more stock offerings as they happen in the months and years ahead. Learn More

Bayer has agreed to acquire Asklepios Biopharmaceuticals, a privately held gene therapy developer formed nearly two decades ago by one of the field's pioneers, University of North Carolina researcher Jude Samulski. The German healthcare conglomerate will pay $2 billion in cash for AskBio, which has several programs in preclinical and early development as well as its own contract gene therapy manufacturing business. The deal's value could as much as double if AskBio's research hits certain development milestones. The buyout should help establish Bayer as an emerging player in the cell and gene therapy field, something it's sought to accomplish through dealmaking. Learn More

The U.S. FDA inspects a few thousand drug manufacturing plants every year to ensure their standards are up to par. Many of those inspections are required before a biopharma company can gain approval of a new drug. They serve as a check on whether drugmakers can produce quality therapies. But that won't be the case for Covid-19 vaccine developers that gain emergency authorization of a shot. FDA regulations don't require what's known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA's vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines. Learn More

The US FDA has deferred a decision on Spectrum Pharmaceuticals' SPPI.O drug candidate to treat chemotherapy induced loss of white blood cells in cancer patients due to COVID-19 related travel curbs. This comes after the regulatory agency was unable to inspect the company's South Korea-based manufacturing plant, a step required before the approval of the drug, the company said. The regulator had warned in April it may not be able to sustain its current level of timely reviews and approvals of marketing applications as many of its staff were allocated to the coronavirus crisis. Learn More

The CDC does not back mandates that healthcare workers or other essential employees receive COVID-19 vaccines, with a CDC official stating that the agency would prefer instead to "build trust and confidence" in the vaccine candidates. Along with state and local governments, the CDC is preparing for a national vaccination program and, as part of that plan, is rolling out a marketing campaign that aims to address worries over vaccine safety. The CDC official's comments before an FDA advisory panel come as surveys show decreasing numbers of people say they will get a COVID-19 vaccine as soon as one is available. Learn More

There are serious signs the US FDA is getting cold feet over the notion of issuing emergency use authorizations to allow for the widespread early deployment of Covid-19 vaccines. Instead, it appears the agency may be exploring the idea of using expanded access - a more limited program that is typically used for investigational drugs - in the early days of Covid vaccine rollouts. Whereas a few weeks ago the agency's concern was to protect against the possibility that unproven vaccines would be pushed out prematurely due to pressure from President Trump, now the fear is that early authorization of vaccines could squander a one-time chance to determine how well the various vaccines work and which work best in whom. Learn More

The City of Vacaville, California has signaled the start of the next generation of development of its world class biomanufacturing cluster by announcing plans to expand it on approximately 300 acres adjacent to existing facilities and to name the entire zone the California Biomanufacturing Center. At the same time, the city announced the creation of the California Biomanufacturing Center, Inc., a nonprofit that will accelerate the growth of the sector in Vacaville by working with industry and academic partners to ensure Vacaville remains a place for biomanufacturing to flourish and to ensure that the industry and community thrive together. Learn More

Infuriated by the FDA's defiance in a showdown over the Trump administration's standards for authorizing a coronavirus vaccine, health secretary Alex Azar has spent recent weeks openly plotting the ouster of FDA chief Stephen Hahn. Reportedly going as far as to float potential replacements for Hahn, said one current and two former administration officials familiar with the talks, identifying HHS testing czar Brett Giroir and a pair of career civil servants - FDA Principal Deputy Commissioner Amy Abernethy and longtime regulator Janet Woodcock - as prime candidates to step in as acting commissioner should Hahn be removed. Learn More

The drug industry has been gradually migrating to the cloud for years. But the Covid-19 pandemic has rapidly accelerated that shift for a simple reason: Researchers needed to run the biggest experiment of their lives in record time, and they lacked the power to launch it. In recent months, pharma companies have struck deals with tech giants like Amazon, Google, and Microsoft, which sell cloud services that could provide the computing power urgently needed to search vast libraries of molecules for a potential cure. Drug companies say transitioning to the cloud has cut down the time needed for certain research efforts from months to mere days - precious time as the global health crisis rages on. Learn More

JSR Life Sciences will add 250 jobs at a new double-occupant campus in Geneva, Switzerland that will house operations for the company's KBI Biopharma and Selexis SA affiliates. JSR's 94,000-square-foot site in Geneva will hold KBI's new 60,000-square-foot biologic bulk drug substance manufacturing facility for European customers that is scheduled to go online in mid-2022. The KBI plant will include two 2,000-liter single-use manufacturing trains with process development and analytical testing labs, JSR said. In addition, the JSR site will more than triple Selexis' Geneva footprint with laboratories and office spaces added. Learn More

Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to criminal charges related to its marketing of the addictive painkiller, and faces penalties of roughly $8.3 billion, the Justice Department has announced. The settlement could pave the way for a resolution of thousands of lawsuits brought against the company for its role in a public health crisis that has killed more than 450,000 Americans since 1999. The company's owners, members of the wealthy Sackler family, have agreed to pay $225 million in civil penalties. Prosecutors said the agreement did not preclude the filing of criminal charges against Purdue executives or individual Sacklers. Learn More

Eli Lilly has hired an independent consultant to review a plant producing its COVID-19 antibody drug after receiving a notice from the U.S. health regulator. The company reiterated that it had not received a warning letter from the U.S. FDA following its plant inspection, which was first reported by Reuters. It received an Official Action Indicated (OAI) notice from the FDA in relation to issues at its Branchburg plant in New Jersey, Lilly reiterated.  Reuters originally reported that inspectors who visited Lilly's plant in Branchburg, New Jersey last November found data on various manufacturing processes had been deleted and not appropriately audited, according to government inspection documents. Learn More

Volansi, a provider of middle-mile drone delivery services, has announced that it has begun a commercial healthcare drone delivery project in North Carolina. In collaboration with Merck, known as MSD outside the U.S. and Canada, Volansi is piloting the delivery of cold chain medicines from Merck's Wilson, N.C. manufacturing site to Vidant Healthplex-Wilson, as the first of three phases in a project to learn about drone technology's role and ability to improve access to healthcare. With 1.4 million people across 29 counties, eastern North Carolina's vast, rural environment can create challenges for accessing care. Initial flights in the project resulted in the first drone delivery of temperature-controlled medicines within the U.S. Learn More

AbSci has raised $65 million in equity, proceeds from which will be used to increase production capacity, expand AbSci's facility and support research and development, the company said in its announcement. AbSci's protein printing technology expedites the biopharmaceutical discovery and development process. The news comes about 10 months after AbSci raised a $10.4 million round and $5 million in debt. The company had doubled its space in downtown Vancouver and installed new equipment. AbSci's current raise is the largest by a Portland-area biotech company this year. Learn More

ABEC has announced that it is delivering process systems to Ology Bioservices, a full-service biologics CDMO, to support their production of critical vaccines and therapeutics for COVID-19. These systems, consisting of stainless steel and CSR single-use solutions, will be part of Ology's Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) facility in Alachua, Florida. The site is a flexible, multi-product facility, utilizing stainless steel and single-use technologies to accelerate the production of vaccines and therapeutic antibodies. ABEC was selected for their ability to deliver customized bioprocess systems for solutions preparation and filtration applications on a fast-track schedule. Learn More

One of our own, Matt Croughan, has published a book titled "COVID-19: A Guide to Home Healthcare". It is based on his personal experience of having had a severe case of COVID-19 for 6 months. Topics addressed in the book include how best to prepare for, manage and recover from COVID-19, including advice on how to have a mild case as opposed to a severe case. A key element of the book is it approach to the reader, choosing to focus on everyday terms when explaining the science instead of scientific jargon and torrents of numbers. The book can be found on Amazon. Learn More

While the world waits eagerly for a safe and effective vaccine to prevent infections from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus behind the COVID-19 pandemic, researchers also are focusing on better understanding how SARS-CoV-2 attacks the body in the search for other means of stopping its devastating impact. The key to one possibility - blocking a protein that enables the virus to turn the immune system against healthy cells - has been identified in a recent study by a team of Johns Hopkins Medicine researchers. Based on their findings, the researchers believe that inhibiting the protein, known as factor D, also will curtail the potentially deadly inflammatory reactions that many patients have to the virus. The study was published recently in the journal Blood. Learn More

Two new pilot programs related to manufacturing quality management have been launched by the US FDA. The agency's Center for Drug Evaluation and Research (CDER) is hoping to "gain insight from third-party assessments of a manufacturer's quality management system to inform future development of an FDA rating system," according to CDER's announcement to industry of the new pilot programs. The rating system that FDA hopes to develop from the pilot programs would better allow an apples-to-apples comparison of facilities, which could be of benefit to a variety of stakeholders including healthcare facilities and consumers. The initiative is part of the broader FDA effort to shift to risk-based pharmaceutical quality assessment systems. Learn More

U.S. drug giant Pfizer has started work manufacturing hundreds of thousands of Covid-19 vaccines ahead of an expected U.S. approval in November, the Mail on Sunday reports. The coronavirus vaccines are being made at the company's factory in Puurs, Belgium, according to the Mail on Sunday, who interviewed Pfizer's U.K. head, Ben Osborn and showed a video that appears to show Pfizer's manufacturing process, although it is not clear whether the clip shows the Covid-19 vaccine being manufactured. The company says it hopes to make 100 million doses available this year, should the vaccine be granted regulatory approval, with plans to manufacture 1.3 billion in 2021. Learn More

In this well written article published in STAT the author discusses how, in the course of just under two months that started about 40 years ago this week, five events occurred that shaped the biotechnology industry and bioscience research. A period in time that encompassed a Nobel Prize for Chemistry, Genentech's IPO, passage of the Stevenson Wydler Technology Innovation Act, award of the Cohen-Boyer patent and Bayh-Dole becoming law. Looking back on these seminal events is a reminder of the odd ways in which change happens. Learn More

Pfizer has announced that it could file in late November for U.S. authorization of the COVID-19 vaccine it is developing, suggesting that a vaccine could potentially be available in the United States by the end of the year. That timeline makes it unlikely, however, that a vaccine will be available before the U.S. election. Pfizer, which is developing the vaccine with German partner BioNTech, said that it may confirm if the vaccine is effective as soon as this month but that it also needs safety data from a 44,000-person clinical trial that will not be available until next month. Fears of delays were raised after trials for two rival vaccines were put on hold in the United States in recent weeks.  Learn More

UCB has signed an agreement to acquire a new 47-acre campus for its UK operations. The acquisition of the site in Windlesham, Surrey, formerly Eli Lilly's second largest research site in the world, is anticipated to be completed in November 2020. The site will undergo state-of-the-art refurbishment prior to UCB relocating from its current UK headquarters in Slough, Berkshire. UCB's projected investment in the UK, including this site, will be roughly $1.3 billion over five years and the transition to this new facility will support more than 650 high-value jobs in scientific research, translational medicine, clinical development, early manufacturing and commercial roles. Learn More

The flop of a promising drug from Vertex Pharmaceuticals led to a sharp drop in the company's share price this week as analysts questioned the biotech's ability to replicate its success in cystic fibrosis and diversify its revenue. Boston-based Vertex has disclosed that it is stopping development of the experimental drug because of its potential for liver toxicity. The safety concerns arose in a Phase 2 trial for the treatment of a rare liver and lung disease called alpha-1 antitrypsin deficiency, or AATD. Vertex shares fell 19.9%, shedding about $14 billion in market value. Learn More

Disarm Therapeutics, a Cambridge biotechnology firm working on new potential drugs for neurological diseases such as ALS and multiple sclerosis, will be bought by the pharmaceutical giant Eli Lilly and Company for $135 million up front. Under the deal announced this week investors in the four-year-old, privately held biotech could reap up to $1.225 billion in additional payments, depending on how well Lilly does developing and marketing new medicines resulting from the acquisition. Learn More

Merck, known as MSD outside the United States and Canada, this week announced it will construct a new manufacturing facility to significantly expand its production capacity for TICE® BCG, a medicine for the treatment of certain forms of bladder cancer. Once this new facility is fully operational, which could take upwards of 5 years, it will triple current manufacturing capacity. The new facility will be part of the existing Maurice R. Hilleman Center for Vaccine Manufacturing in Durham, North Carolina. While no word yet on the size or cost of the new facility, it is expected to create about 100 new jobs locally. Learn More

The U.S. government has entered into an agreement with Cytiva to expand the manufacturing of products needed to make COVID-19 vaccines. Under the deal, Cytiva will receive about $31 million to scale up manufacturing of vaccine-related products, including cell cultures and hardware such as bioreactors used for the culturing of cells and antibodies. This will include expanded capacity at the company's Massachusetts facilities and the creation of duplicate infrastructure at its site in Logan, Utah. Learn More

The drug discovery pipeline can take, on average, a decade to get from the lab to the patient. Ori Biotech aims to speed up the innovation of cell and gene therapies via the manufacturing platform it is bringing to market. The London and Woodcliff Lake, New Jersey-based company is developing a platform that closes, automates and standardizes manufacturing for cell and gene therapy developers so they can move their treatments from the pre-clinical process through to scale commercially. Helping the company get its platform on the market is a new $30 million Series A round of funding. Learn More

Advanced Instruments, perhaps best known to many of us for their osmolality instruments, has been sold by Windjammer Capital Investors to private equity firm Patricia Industries for $780 million. Windjammer originally purchased the company in October of 2016 from the founders. According to published reports, the new owners plan to work closely with the company's current management team which, along with the board and other key individuals, will have equity participation. Learn More

U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs according to government documents and three sources familiar with the matter. The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation. Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant's various manufacturing processes had been deleted and not appropriately audited, government inspection documents show. Following its November inspection, the FDA issued an "Official Action Indicated" (OAI) notice. Learn More

As an increasing number of biopharmaceutical companies go all-in on artificial intelligence, Takeda has now committed to equipping each of its scientists with cloud-based research tools by the end of this decade. The Japanese drugmaker is launching a five-year transformation initiative-with help from Accenture and Amazon Web Services-to establish an in-house digital engine for rethinking how the company does its day-to-day work. "My vision is that, in less than 10 years, every Takeda employee will be empowered by an artificial intelligence assistant to help make better decisions..." President and CEO Christophe Weber said in a statement. Learn More

MilliporeSigma has bolstered its viral vector manufacturing capabilities with the launch of its VirusExpress Lentiviral Production Platform. According to the company, this new platform helps to overcome lentiviral production challenges and can reduce process development time by approximately 40 percent, based on MilliporeSigma's experience as a contract development and manufacturing organization (CDMO). Using a suspension cell line rather than an adherent-based production, coupled with a chemically defined cell culture media and process with built-in scalability, allows each batch of virus to be larger, yielding more patient doses. Learn More

A new study published in The BMJ finds that only a third of new drugs approved by the US FDA and the EMA in the decade from 2007-2017 have high therapeutic value, according to appraisal by one of five independent organizations. However, the analysis found that drugs approved through expedited programs - and especially EMA's programs - were more likely to have high therapeutic value. "Most of the increase in the number of new drug approvals over the past decade was driven by drugs rated as having low therapeutic value, which calls into question the common practice of using simple counts of new drug approvals as a measure of innovation," the authors write. Learn More

Reversing a trend in which contributions from drugmakers' political committees and their employees have gone largely to Republican candidates for president and Congress, so far for 2020 the industry has tilted toward Democrats. The shift may reflect industry expectations that Democratic presidential candidate Joe Biden will win, said Steven Billet, who teaches courses in corporate lobbying and political donations at George Washington University. Bioharma companies may see campaign largesse as leverage if Biden follows through on promises to address high drug prices, he said. Learn More

Specialty drugmaker Mallinckrodt filed for bankruptcy protection this week in U.S. district court, proposing an updated plan to resolve the billions of dollars in opioid drug-related claims the company faces as well as a high-profile federal lawsuit over rebate payments owed to Medicaid. Mallinckrodt had contemplated seeking bankruptcy protection earlier this year, but only for the generic drug subsidiary that made the opioid painkillers sold by the pharma. This week's filing is much broader, involving the Dublin-based parent company and "substantially all of its U.S. subsidiaries." Most of the drugmaker's unsecured creditors have agreed to the proposed restructuring, the company said. Learn More

The United States and the world were caught unprepared by the COVID-19 pandemic despite decades of warnings of the threat of global pandemics and years of international planning. The failure to adequately fund and execute these plans has exacted a heavy human and economic price. The crisis-the greatest international public health emergency in more than a century-is not over. It is not too early, however, to begin distilling lessons from this painful experience so that the United States and the world are better positioned to cope with potential future waves of the current pandemic and to avoid disaster when the next one strikes, which it surely will. Learn More

AstraZeneca has secured $486 million from the U.S. government's Biomedical Advanced Research and Development Authority to support the development of AZD7442, an antibody cocktail for the treatment and prevention of COVID-19. For its support, BARDA will get up to 100,000 doses of the drug and has the option to purchase up to 1 million additional doses of the treatment in 2021. The company didn't disclose the value of the potential million-dose contract. AZD7442 is a cocktail of two long-acting antibodies designed to last for six to 12 months, making it especially useful for long-term prevention of COVID-19. Learn More

Abzena has invested $60 million into a new facility for late phase and commercial cGMP manufacturing. The new roughly 50,000 sq ft 'Lusk' facility, at the company's site in San Diego, CA, houses a process development laboratory and two new cGMP manufacturing cleanrooms for 500L and 2,000L scale in Sartorius single use bioreactors. The facility also houses a GMP warehouse, and analytical development and quality control (QC) laboratories. The new 7,400 sq ft process development laboratory uses Sartorius single-use technology (SUT) bioreactors from Ambr® 250mL to 2L, 50L and 200L STR bioreactor to screen important process parameters to develop robust scaleable processes and ensure seamless manufacturability. Learn More

Investment group Bridgewest has bought the Adelaide biologics manufacturing plant operated by Pfizer and will develop it into a contract drug and vaccine manufacturer. Pfizer, which operates four Australian factories employing 1,000, sold the Thebarton plant for an undisclosed sum to the tightly-held investment group which founded the BioDuro drug manufacturing operations in the United States and China. The Adelaide facility has product development, commercialisation and manufacturing capability in microbial-based products such as proteins, vaccines, and plasmids. It will continue to be operated by Pfizer subsidiary Hospira Adelaide until the third quarter of 2021, when Bridgewest will take control. Learn More

After more than two decades that saw it become this region's largest biotechnology company, Seattle Genetics is no more. But that's only because it has changed its name. The new name is Seagen, it said in a regulatory filing this week. In a statement, president and CEO Clay Siegall said the change "reflects who we are today, as we expand our presence beyond the Pacific Northwest and outside of the United States. The rebranding comes as the company is on a roll - it recently landed a $1 billion investment from Merck, along with agreements that could bring billions more for collaboration efforts using Seagen's cancer drugs. Learn More

Eppendorf has moved its Americas Market Region Commercial headquarters to Framingham from Hauppauge, N.Y. The move will bring with it an estimated 50 employees to the office, located at 100 Crossing Blvd. The 14,000-square-foot location will serve as the home office for American commercial operations including marketing, sales, and the executive team. "We are excited to join the Massachusetts life science community," Dennis Barger, president of Eppendorf Americas, said in a press release. The American company is a subsidiary of Eppendorf AG, which is located in Hamburg, Germany. Learn More

It's CRISPR. Two scientists who pioneered the revolutionary gene-editing technology are the winners of this year's Nobel Prize in Chemistry. The Nobel Committee's selection of Emmanuelle Charpentier, now at the Max Planck Unit for the Science of Pathogens in Berlin, and Jennifer Doudna, at the University of California, Berkeley, puts an end to years of speculation about who would be recognized for their work developing the CRISPR-Cas9 gene-editing tools. The technology allows precise edits to the genome and has swept through laboratories worldwide since its inception in the 2010s. Learn More

A top FDA official has warned vaccine makers that the agency could call upon rarely-used powers to disclose significant safety issues. Speaking at an online event hosted by Johns Hopkins University and the University of Washington, FDA Center for Biologics Evaluation and Research Director Peter Marks said he "would encourage any manufacturers of a vaccine, any sponsor of a vaccine to be as transparent as possible." He followed up by invoking the potential use of what's called a commissioner's finding, a rarely used FDA power by which the agency can announce serious safety concerns on the way to potentially banning use of a product. Learn More

Eli Lilly and Co has applied for U.S. emergency use authorization (EUA) for its experimental COVID-19 antibody treatment and plans to pursue a similar approval for a dual antibody therapy next month after it produced promising data. The drugmaker said its two-antibody cocktail helped reduce viral levels more than the single antibody treatment had in a prior study. The lower viral load was potentially tied to a reduction in COVID-19 symptoms, the company said. Based on that data, Lilly applied for an EUA with the U.S. FDA and said it expects about one million doses of the biotech drug to be available by the end of the year. Learn More

Amid reports that the White House had blocked stricter guidance from the US FDA on emergency use authorizations (EUAs) for COVID-19 vaccines, the agency has issued guidance hours after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting. The FDA appears to have sidestepped the White House by releasing five pages of advice given to vaccine makers on COVID-19 vaccine EUAs in briefing documents for its upcoming Vaccines and Related Biologics Advisory Committee meeting. Hours later, in a surprise move, the FDA released its COVID-19 vaccine EUA guidance in full. Learn More