News Alert

Roche has agreed to pay roughly $450 million for biotech startup Inflazome. The deal gives Roche rights to a portfolio of small molecule drugs that target inflammasomes, protein complexes within immune cells that are implicated in inflammation. Inflazome's drugs, specifically, block the NLRP3 inflammasome, which is involved in a wide variety of diseases, from Alzheimer's to diabetes and non-alcoholic steatohepatitis. The idea of drugging the NLRP3 inflammasome has drawn the interest of companies like Roche, Novartis and Bristol Myers Squibb because of its potentially broad role in the body. The Inflazome deal marks the second acquisition Roche has made specifically for NLRP3 blockers. Learn More

Illumina and GRAIL have announced they have entered into a definitive agreement under which Illumina will acquire GRAIL for cash and stock consideration of about $7.1 billion.  GRAIL was founded by Illumina in 2016 and was spun out as a standalone company, powered by Illumina's NGS technology, to develop state-of-the-art data science and machine learning and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests. GRAIL raised approximately $2 billion to support its innovative technology platform and develop Galleri. Alert readers will recall that rumors of the acquisition became public late last week. Learn More

Confidence in potential COVID-19 vaccines is slipping, with only 51 percent of Americans in a new poll saying they would get a vaccine if it was available today, compared to 72 percent who said the same four months ago. The roughly half of Americans who said they'd get a vaccine includes 21 percent who said they would "definitely" get one, compared to 42 percent that said the same in May, according to a poll from the Pew Research Center. The percentage of people who said they would "probably" get the vaccine remained at 30 percent from May to September. Learn More

In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation's health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation's foods, medicines, medical devices and other products, including vaccines. Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power "is reserved to the Secretary." The bulletin was sent to heads of operating and staff divisions within H.H.S. It's unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Learn More

Moderna CEO Stephane Bancel says the Cambridge biotech will probably know in November whether its COVID-19 vaccine is safe and effective and could deliver 100 million doses to the US government in the "first few months of 2021." The company, which is enrolling 30,000 participants in a late-stage clinical trial, had hoped it might have interim results in October, Bancel said. But a slight decline in the average number of coronavirus cases in the country recently has made it harder to reach the minimum number of infections among participants to assess whether the vaccine works better than a placebo. Learn More

Kicking a football through a ceremonial goalpost, Lou Kassa joined with founders and county officials to celebrate the launch of a $19 million expansion of the Pennsylvania Biotechnology Center, a long-awaited project that is expected to bring more than 100 new jobs to the facility after its planned fall 2021 opening. "We've been at full capacity for the past seven years and we have a waiting list of companies that want to locate in the PABC," said Kassa, executive vice president of the PABC and the Blumberg Institute, which manages the center. "At the same time, there will be opportunities for new companies to move into the PABC with our expansion." Learn More

In a scramble to restore fading public trust in the coronavirus vaccine pipeline, two leading pharmaceutical companies released their trial plans for the first time this week. Those details - first published by Moderna, then by Pfizer - provide some clarity about a process that many scientists and Democrats fear is being rushed by the Trump administration ahead of the November election. The documents from Moderna and Pfizer suggest that the trials may need to run through at least the end of the year to determine whether their vaccines are safe and effective. Learn More

Eli Lilly has partnered with Amgen to increase the supply of its experimental COVID-19 antibody treatments, a day after one of the drugs was shown to reduce the need for hospitalization. Through the collaboration, the two companies will have the ability to scale up production should one or more of Lilly's antibody therapies prove receive regulatory approval, the companies said in a statement. Eli Lilly this week reported that a single infusion of its experimental antibody treatment cut hospitalizations and emergency room visits for clinical trial patients with moderate COVID-19. Learn More

BioNTech is buying a production site for the COVID-19 vaccine it is developing with Pfizer, aiming to boost output by several hundred million doses next year, and hopes to have the shot ready to file for approval in October. It is buying the facility, in the German city of Marburg, from Swiss drugs giant Novartis. The facility will be converted to be fully on stream in the first half of 2021 with an annual production capacity up to 750 million doses of the inoculation. The transaction with Novartis, for which the price tag was not disclosed, is part of a push to prepare for a global roll-out of the pair's experimental vaccine, based on so-called messenger RNA (mRNA) technology. Learn More

Genetic sequencing giant Illumina is in talks to acquire cancer-detection startup Grail Inc., according to people familiar with the matter. Illumina could pay more than $8 billion for Grail, said the people, who asked not to be identified as the details aren't public. The startup had a valuation of $6 billion from its previous fundraisings, said the people. As a private company Grail has raised more than $1.9 billion, regulatory filings show. The companies could announce a deal as soon as this week, said the people. No final decision has been made and talks could fall apart. The acquisition could be Illumina's biggest ever deal. Learn More

Billionaire philanthropist Bill Gates has invested $17.5 million in the biotechnology company Univercells. This is the fourth time Gates has put money into the company, which has developed a sort of miniature production line capable of turning out large volumes of vaccines at low cost. His introduction to the company came in 2016, and he has invested some $35 million since. The company has so far declined to comment on the capital round, apparently because it is not yet complete, and Univercells hopes to attract more investors. However it is known that the company intends to set up more production lines for vaccines, including for Covid-19. Learn More

The office, as we've been told many times, is over. As the coronavirus pandemic drags on in the U.S., millions of white-collar workers remain homebound, companies are shedding their HQ spaces, and the viability of downtown business districts - and even whole cities -  is in doubt due to the ongoing economic devastation of Covid-19. But most people who work in the life sciences - pharmaceutical, biotech and other medical research fields - can't do their jobs from their couches or backyard sheds. For them, the pandemic has helped fuel a real estate scramble. Learn More

Germany awarded $745 million in funding to biotech firms BioNTech and CureVac this week to speed up work on COVID-19 vaccines and expand German production capacity. The deal calls for BioNTech to receive $445 million and CureVac $300 million. The German government says it is still in talks to provide funding to a third company, IDT Biologika, which produces vaccines for other pharmaceutical companies and is working on its own so-called viral vector vaccine. According to published reports a vaccine is not expected to be widely available in Germany until the middle of 2021. Learn More

A closely watched late-stage study of Pfizer's experimental coronavirus vaccine remains on track to deliver initial results by the end of October, company CEO Albert Bourla affirmed this week, despite a slowing rate of infections in the U.S. Just over 29,000 people had enrolled in the Phase 3 study by last Friday and, as of Monday morning, 12,000 of them had received the second shot in the two-dose regimen used for Pfizer's vaccine. In an unusual disclosure, Pfizer also shared safety results through late August for several thousand of the volunteers in the trial showing reported side effects were generally mild to moderate. Learn More

Unity Biotechnology, whose clinical trial in osteoarthritis of the knee failed last month in clearing away dead cells thought to play a role in inflammation, will cut 30% of its workforce to focus its remaining cash on eye and brain diseases. The restructuring will leave the company with roughly 75 employees. The move will help to stretch Unity's available cash through mid-2022, funding it through the readout of a clinical trial of UBX-1325, an experimental drug to treat diabetic macular edema, an eye disease that causes blurred or distorted vision. A Phase I study of the drug is expected to dose its first patient later this year. Learn More

Merck has made public its plans to purchase a $1 billion equity stake in Seattle Genetics and co-develop as well as sell the biotech's cancer therapy, ladiratuzumab vedotin. The collaboration will assess ladiratuzumab vedotin in combination with Merck's blockbuster drug Keytruda in types of breast cancer and other solid tumors. Under to terms of the deal, Seattle Genetics will receive an upfront payment of $600 million and Merck will invest an additional $1 billion to buy 5 million shares of Seattle Genetics. This comes just hours after Gilead announced its $21 billion acquisition of Immunomedics. Learn More

A forthcoming study from genetic testing giant 23andMe shows that a person's genetic code could be connected to how likely they are to catch Covid-19 - and how severely they could experience the disease if they catch it. It's an important confirmation of earlier work on the subject. People whose blood group is O seemed to test positive for Covid-19 less often than expected when compared to people with any other blood group, according to 23andMe's data; people who tested positive and had a specific variant of another gene also seemed to be more likely to have serious respiratory symptoms. Learn More

The long-running patent battle over CRISPR has taken a new twist that vastly complicates the claims made by a team led by the University of California (UC). The Patent Trial and Appeal Board (PTAB) has ruled that a group led by the Broad Institute has "priority" in its already granted patents for uses of the original CRISPR system in eukaryotic cells, which covers potentially lucrative applications in lab-grown human cells or in people directly. But the ruling also gives the UC group, which the court refers to as CVC because it includes the University of Vienna and scientist Emmanuelle Charpentier, a leg up on the invention of one critical component of the CRISPR tool kit. Learn More

Gilead Sciences to acquire biopharmaceutical company Immunomedics for $21 billion. The deal with Immunomedics provides Gilead with Trodelvy, an antibody drug for advanced triple-negative breast cancer. The drug was given accelerated FDA approval in April. The deal is anticipated to close in the fourth quarter of 2020, according to the companies. The deal will be funded by $15 billion in cash on hand and roughly $6 billion in newly issued debt, Gilead said. "This acquisition represents significant progress in Gilead's work to build a strong and diverse oncology portfolio," Gilead Chairman and CEO, Daniel O'Day said in a statement. Learn More

President Trump has signed a new executive order to lower the cost of prescription drugs, he revealed on Twitter. Trump announced that the aim of the order is to reduce prices to give America "the same low price Big Pharma gives to other countries." "Just signed a new Executive Order to LOWER DRUG PRICES! My Most Favored Nation order will ensure that our Country gets the same low price Big Pharma gives to other countries," the president tweeted. "The days of global freeriding at America's expense are over..." "...and prices are coming down FAST! Also just ended all rebates to middlemen, further reducing prices," he added in a follow-up tweet. Learn More

Cytiva, formerly known as GE Healthcare Lifesciences, is expanding its manufacturing capacity globally. To accomplish this the company has announced plans to invest about $500 million to address in-region, for-region demand, bolster security of supply through dual manufacturing, and increase overall global capacity in key product areas. Cytiva is investing in talent, too, hiring nearly 1,000 people around the world. The impact will be to more than double the company's manufacturing capacity for single-use products globally with capacity in Asia set to triple through an ongoing partnership with Wego in China. Learn More

The head of the US FDA, Commissioner Stephen Hahn, said he has "no intention" of overruling career scientists at the agency on an approval of a coronavirus vaccine even though he has the authority. He went on to add that any vaccine data released will be discussed publicly by an advisory committee of outside experts and that Peter Marks, who runs the FDA division that oversees vaccine approvals, will ultimately make a recommendation. "I have complete and absolute confidence in the scientists at the FDA and the decision-making that they have here," he added. Learn More

The delivery of any future coronavirus vaccine requires "careful planning" with the air transport industry now in order to avoid "potentially severe" issues when it's ready for global distribution, the International Air Transport Association (IATA) has warned. Calling it the "largest single transport challenge ever," the air transport body called on governments to start preparing for the large-scale delivery of a Covid-19 vaccine. "The potential size of the delivery is enormous. Just providing a single dose to 7.8 billion people would fill 8,000 (Boeing) 747 cargo aircraft," IATA said this week. Learn More

Merck KGaA announced this week that it would invest $69.5 million in expanding its manufacturing capabilities, and capacity for high-potent active pharmaceutical ingredients and antibody-drug conjugates at its U.S. facility near Madison, Wisc. The biopharma company said the investment would allow manufacturing of compounds for therapies which have the potential to treat cancer, and it would create roughly 50 full-time jobs starting in 2021. Completion of the expansion, which consists of a roughly 70,000 square foot commercial building, is expected by mid-2022, the company said. Learn More

Catalent is investing $130 million to bolster manufacturing capacity at its gene therapy campus in Maryland. The company said the site in Harmans will add five Phase III to commercial-scale manufacturing suites, bringing the two state-of-the-art facilities to a total of 15 such suites. Catalent said 10 of the suites are expected to be qualified and operational by the first quarter of 2021, now that the first facility has been approved by the FDA for commercial manufacturing. The new building and its five suites are expected to be operational in the first half of 2022. The new building will also offer cold storage warehousing, office space and more. Learn More

Researchers from the Institute for Protein Design at the University of Washington School of Medicine have used computers to originate new proteins that bind tightly to SARS-CoV-2 Spike protein and obstruct it from infecting cells. Coronaviruses are studded with so-called Spike proteins. These latch onto human cells to enable the virus to break in and infect them. The findings are reported this week in Science. In the experiments, the lead antiviral candidate, named LCB1, rivaled the best-known SARS-CoV-2 neutralizing antibodies in its protective actions. The development of drugs that interfere with this entry mechanism could lead to treatment of or even prevention of infection. Learn More

G-CON this week unveiled its new Standard POD product line. The Standard POD designs will maximize efficiencies related to production, qualification, delivery and cost reduction and eliminate the complexity of cleanroom construction projects. G-CON's standard POD portfolio encompasses six PODs, three different dimensions with bi-directional and uni-directional flow approaches and all featuring ISO 7 classification. These units can ably support development and clinical scale operations for cell therapies, formulation and filling, drug substance, etc. and meet the building block approach to allow for configuration and assembly of multiple units to meet clients' segregation and space requirements. Learn More

Vaccinations in studies of AstraZeneca and the University of Oxford's experimental coronavirus shot are on hold after an unexplained illness in one participant triggered a safety review. The trial pause was first reported by STAT. AstraZeneca acted on its own to stop testing, the company said in a statement, but provided little other information about the adverse event. Such safety reviews are a standard part of clinical testing and it's not yet clear whether the illness was directly attributable to vaccination, nor how long a hold might last.  The hold applies to all studies of AstraZeneca and Oxford's vaccine, including the large Phase 3 trial began last week in the U.S. Learn More

In a recent filing with the SEC, Five Prime Therapeutics has made public the decision to sublease its lab and office space at 111 Oyster Point Blvd in South San Francisco, California. The terms of the deal have Sutro Biopharma initially acquiring 85,755 sq. ft. of the site in April, 2021. The remainder of the site, roughly 29,711 sq. ft., would be occupied some 24 months later. According to the filing the sublease will expire in December, 2027. Alert readers will recall that initial rumors of Five Prime's possible need to sublease the site began circulating in the latter part of 2019. Learn More

Corbus pharmaceuticals saw its shares fall more than 75% after its phase 3 trial of lenabasum in cutaneous systemic sclerosis patients failed to beat out placebo. The topline data, with a more detailed look to come, showed no significant differences in both the primary and secondary endpoints when comparing FDA fast-tracked lenabasum to a dummy treatment, both of which were added to background, typically immunosuppressive drug therapy. The biotech said the issue appeared to be down to an unusually high placebo response. Learn More

President Trump may want a Covid-19 vaccine to ship in time to boost his reelection chances, but the biopharma industry doesn't appear ready to cooperate - at least, not on his terms. In a highly unusual turn of events, nine vaccine makers - including some of the world's biggest companies - plan to issue their own public pledge not to seek government approval without extensive safety and effectiveness data today. This follows a fairly similar open letter the BIO trade group released last week warning any vaccine or therapy should only become available with the same sort of "rigorously considered" data. Learn More

Abbvie has announced that it will partner with Shanghai-based I-Mab on the development of lemzoparlimab, a drug that targets CD47. The antigen target, also known as the "don't eat me" signal, is a growing area of immunotherapy, as illustrated by Gilead's $4.9 billion buyout of Forty Seven earlier this year. Under the deal, I-Mab will receive an upfront payment of $180 million, along with a $20 million milestone payment based on Phase I results for the drug. I-Mab will also be eligible to receive milestones of up to $1.74 billion, $840 million of which come from clinical development and regulatory approval. Learn More

The U.S. Food and Drug Administration is concerned that generics giant Mylan has deep-rooted problems in its global manufacturing network, with the latest evidence coming from a site in India. The agency has posted a warning letter about Mylan's Unit 7 facility, which makes dozens of APIs used in blood pressure drugs, antifungals and central nervous system treatments. During a February inspection, regulators found the site did not have adequate procedures in place to prevent contamination. They noted that similar issues were seen last year at Unit 8, another Mylan plant located in India. Learn More

When effective COVID-19 vaccines are developed, their supply will inevitably be scarce. The WHO, global leaders, and vaccine producers are already facing the question of how to appropriately allocate them across countries. And while there is vocal commitment to "fair and equitable" distribution, what exactly does "fair and equitable" look like in practice? Now, nineteen global health experts from around the world have proposed a new, three-phase plan for vaccine distribution -- called the Fair Priority Model -- which aims to reduce premature deaths and other irreversible health consequences from COVID-19. It has been published this week in Science. Learn More

A group of prominent biotech CEOs are calling on their peers and the federal government to hold themselves to the highest standards when it comes to developing and reviewing Covid-19 treatments. Among their demands: That biotech companies don't simply release clinical trial data in press releases, and that federal regulators make it clear to the public that any vaccines or treatments will be approved strictly based on science. The recommendations were laid out in an open letter organized by the Biotechnology Innovation Organization. The letter comes amid growing concern among the American public over the politicization of the Covid-19 pandemic. Learn More

California is poised to become the first state to develop its own line of generic drugs, targeting soaring drug prices and stepping into a fiercely competitive drug market dominated by deep-pocketed biopharma companies. The Democratic-controlled Legislature overwhelmingly approved a measure this week that would direct the state's top health agency to partner with one or more drug companies by January to make or distribute a broad range of generic or biosimilar drugs - including the diabetes medicine insulin - that are cheaper than brand-name products. The bill, SB-852, also opens the door for California to make its own generic drugs in the future. Learn More

GlaxoSmithKline is opening a $13+ million research base in King's Cross, London to tap into the area's world-beating artificial intelligence brains and try to find new treatments for cancer and other serious diseases. The redeveloped King's Cross area has become one of the world's foremost centers for such technology. Google's world-renowned DeepMind is based there, plus a growing list of innovative new start-ups. Glaxo's site, which opened this week, will initially house 30 scientists and engineers who will collaborate with their new neighbors including the Francis Crick and Alan Turing research institutes. Learn More

The U.S. FDA will organize meetings with an independent group of experts to review data of coronavirus vaccine candidates and advise the agency, FDA commissioner Stephen Hahn said this week. "The meetings will reinforce the transparency of the process as FDA reviews data from trials now underway," Hahn said in a post on Twitter. The statement comes after U.S. President Donald Trump last month accused members, without evidence, of a so-called "deep state" working within the FDA of complicating efforts to test COVID-19 vaccines in order to delay results until after the Nov. 3 presidential election. Learn More

A panel of advisers for the NIH was not convinced convalescent plasma should be used to treat COVID-19, a recommendation that appears to conflict with a controversial decision by the U.S. FDA last week to issue an emergency authorization for the blood-derived treatment. The panel, made up of doctors from across the country and government officials, reviewed the same data cited by the FDA, but concluded it to be "insufficient" to recommend "either for or against the use of convalescent plasma for the treatment of COVID-19." Learn More

Gilead Sciences has announced an agreement with Jounce Therapeutics to exclusively license its JTX-1811 program. JTX-1811 is a monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. Under the terms of the agreement, Gilead will make a $85 million upfront payment to, and a $35 million equity investment at a premium in, Jounce upon closing. In addition, Jounce may receive up to an additional $685 million in future clinical, regulatory and commercial milestone payments. Jounce will also be eligible to receive royalties based upon worldwide sales. Learn More

Intercept Pharmaceuticals is cutting one-fourth of its workforce, a decision that comes two months after the FDA rejected its drug candidate for the liver disease nonalcoholic steatohepatitis (NASH). Up until the FDA's rejection of the drug, obeticholic acid (Ocaliva), Intercept had been preparing for a drug launch. In a securities filing this week, the biopharma company attributed the layoffs to the FDA's negative decision. About 170 Intercept employees are affected by the cuts, which the company says will enable it to streamline operations and reduce expenses while also maintaining resources to support its drug programs-including the failed NASH drug. Learn More

Novartis has announced that it is constructing a new production unit for experimental drugs on the outskirts of the city of Basel. The roughly $78 million investment will give it two new production lines. Both will be dedicated to producing active ingredients for experimental medicines. The production lines will be developed in an existing building in the Schweizerhalle industrial area on the outskirts of Basel. These new facilities will be commissioned at the end of next year. This investment confirms the importance of Schweizerhalle as a global production site, Novartis said. Learn More

Nestle will pay $2 billion to buy the remaining stake in Aimmune Therapeutics, gaining full ownership of the first U.S.-approved peanut allergy treatment which has struggled with a slow launch due to the COVID-19 pandemic. The deal helps Nestle, known for its KitKat chocolate bars and Nescafe instant coffee, expand its Nestle Health Science division which it set up in 2011 to open up a new area of business. With Nestle's prior investment of $473 million, it would be making a cash payment of just under $2 billion, Nestle Health head Greg Behar told Reuters. Learn More

Ionis Therapeutics plans on paying half a billion dollars to acquire Akcea Therapeutics, a company it spun out in 2017 to help develop and commercialize some of its medicines. The move, according to a recent announcement, offers "strategic value" and "significant financial benefits," including the target company's roughly $390 million in cash on hand. Per deal terms, Ionis has agreed to buy the approximately 24% of common stock in Akcea that it doesn't already own. The move represents a strategic shift for Ionis, which for years had preferred to license its drugs out rather than sell them on its own and hatched Akcea as part of that plan. Learn More

Seventy-eight percent of Americans worry the Covid-19 vaccine approval process is being driven more by politics than science, according to a new survey from STAT and the Harris Poll, a reflection of concern that the Trump administration may give the green light to a vaccine prematurely. The response was largely bipartisan, with 72% of Republicans and 82% of Democrats expressing such worries, according to the poll, which was conducted last week and surveyed 2,067 American adults. The sentiment underscores rising speculation that politics may pressure the FDA to approve or authorize emergency use of at least one Covid-19 vaccine prior to the election, but before testing has been fully completed. Learn More

The Trump administration has announced that it will purchase 150 million rapid coronavirus tests from Abbott Laboratories for about $750 million. Alert readers will recall that the portable antigen tests, which can deliver results within 15 minutes and will sell for $5, received emergency use authorization from the U.S. FDA last week. The portable test from Abbott is about the size of a credit card, requires no additional equipment to operate, and can be conducted using a less invasive nasal swab than traditional lab tests. Antigen tests are cheaper and faster than molecular diagnostic tests, but somewhat more likely to fail to identify positive cases of the virus than lab-based diagnostic tests. Learn More

Analysts at SVB Leerink are raising concerns about the reported storage requirements of the COVID-19 vaccines being developed by Pfizer and Moderna. According to published reports, while Sanofi and Novavax's vaccines are able to be stored at refrigerated temps for months, the same cannot be said for the others. In the case of the vaccine being developed by Pfizer and BioNTech, it is understood to require roughly -94 degrees Fahrenheit and will last only 24 - 48 hours at refrigerated temperatures. While Moderna's vaccine is understood to be targeting a -4 degrees Fahrenheit storage requirement but have similar limitations once at refrigerated temperatures. Learn More

Plastic and silicone tubing manufacturer NewAge Industries is now able to recycle the waste from its silicone tubing and braid reinforced hose extrusion processes. The recycled "scrap," as it is called, finds new life as silicone oil for industrial applications. Tubing scrap is created at the beginning and end of the extrusion process as technicians adjust the equipment for proper tubing dimensions. That tubing, and any other that does not meet the company's strict quality standards, is collected and stored in bulk containers. The containers are then shipped to ECO USA, a company that specializes in reclaiming silicone oil. Both unreinforced silicone tubing and braid reinforced hose are sent to the recycler. Learn More

AVEVA has announced an agreement to acquire OSIsoft, perhaps best known for its PI platform, for $5.0 billion. AVEVA and OSIsoft will combine their complementary product offerings, bringing together industrial software and data management. OSIsoft's data management software will complement AVEVA's comprehensive end-to-end engineering, operations, and performance offerings. Integrating OSIsoft's PI System into AVEVA's comprehensive software portfolio will create an integrated data foundation that can drive big data, Cloud and AI-driven insights to create meaningful business outcomes for customers. Learn More

CPI has signed partnership agreements with Siemens plc, Perceptive Engineering LTD and Process Systems Enterprise LTD (PSE), making them a part of the Medicines Manufacturing Innovation Center collaboration. The partnership agreements will help strengthen the UK's position as a global leader in biopharma manufacturing through the development of continuous manufacturing innovations. Each partner will contribute to the development of a digital manufacturing solution, which will help the biopharma industry as it moves towards smaller batches of more personalized medicines that require faster and more efficient manufacture. Learn More

Regeneron has announced plans to expand operations at its site in Limerick, Ireland adding roughly 400 new jobs. The expansion is a result of a decision to prepare Regeneron's plant in New York to produce a potential new antibody-based treatment for Covid-19, REGN-COV2. The new roles will be in a wide variety of areas, including commercial manufacturing, process sciences, quality assurance/control, supply chain and various support functions for scientists, chemists and technicians. Regeneron has been in Limerick since 2014, when it took over the old Dell factory in the city and has since invested over $1 billion in its campus which became operational in 2015. Learn More

The US FDA has authorized emergency use of a coronavirus test that costs $5 and can produce results in 15 minutes without the use of any lab equipment. Test-maker Abbott says it could soon manufacture 50 million of the rapid antigen tests per month, which could ease the country's testing bottleneck by greatly increasing overall capacity and the speed at which results arrive. Abbott's test is designed for use within seven days of the onset of symptoms. It gives results on a card reminiscent of the stick used in many over-the-counter pregnancy tests. If one line appears on the card, the patient is negative for the coronavirus; two lines indicates a positive result. Learn More

Amgen has licensed out an experimental heart disease drug to a newly formed biotech called NewAmsterdam Pharma. The drug, obicetrapib, was acquired by Amgen when it purchased Dezima in 2015 but the drug was shelved two years later. Some former Dezima founders have started NewAmsterdam and reacquired obicetrapib in an effort to revive the drug around a different clinical development plan. They are in talks with the FDA and EMA about a Phase 3 program and aim to raise "substantial" financing to back it by the end of the year. The terms of the deal have not been made public. Learn More

Autifony Therapeutics, a GSK spin-out specializing in CNS disorders, has regained full rights to its Kv3 program from Boehringer Ingelheim. Under the agreement, Autifony received a $30 million upfront sum, followed by roughly $20 million in milestone payments during the option period. The decision by Boehringer not to excerise its option on Kv3, which was signed back in 2017, was apparently made for strategic reasons. For its part, Autifony says that the Kv3 program progressed significantly during the collaboration, obtaining positive data in a ketamine challenge clinical trial in healthy volunteers, in which the lead molecule, AUT00206, demonstrated clear CNS target engagement. Learn More

U.S. prosecutors this week announced fraud charges against Sepehr Sarshar, the 53-year-old founder of Auspex who the government says alerted his friends and family that his company was being purchased by pharma giant Teva in 2015 before the deal was announced. According to the DOJ's criminal complaint, Sarshar tipped off two friends, a girlfriend, and a relative that Teva intended to make an offer to buy the neurology treatment developer for $3.5 billion. The DOJ also said that Sarshar lied about the case to investigators from an industry regulator, saying he could not recall any contact with two of the people he allegedly alerted to the deal during the period before it was announced. Learn More

AstraZeneca has begun testing an antibody-based cocktail for the prevention and treatment of COVID-19, adding to recent signs of progress on possible medical solutions to the disease caused by the novel coronavirus. The biopharma said the study would evaluate if AZD7442, a combination of two monoclonal antibodies (mAbs), was safe and tolerable in up to 48 healthy participants between the ages of 18 and 55 years. If the UK-based early-stage trial, which has dosed its participants, shows AZD7442 is safe, AstraZeneca said it would proceed to test it as both a preventative treatment for COVID-19 and a medicine for patients who have it, in larger, mid-to-late-stage studies. Learn More

In a business driven by profit, vaccines have a problem. They're not very profitable - at least not without government subsidies. Last year only four companies were making vaccines for the U.S. market, down from more than 20 in the 1970s. Oxford University surprised and pleased advocates of overhauling the vaccine business in April by promising to donate the rights to its promising coronavirus vaccine to any drugmaker. The idea was to provide medicines preventing or treating COVID-19 at a low cost or free of charge, the British university said. A few weeks later, Oxford reversed course by signing an exclusive vaccine deal with AstraZeneca. This article explores the story behind the reversal. Learn More

AstraZeneca says it hasn't talked to the U.S. government about an emergency use authorization for its coronavirus vaccine - a day after news reports that the Trump administration may greenlight the vaccine's use before the election. "It would be premature to speculate on that possibility," the biopharma company said in a statement. This comes after The Financial Times reported that the White House was considering a plan to allow emergency use of the AstraZeneca vaccine if a late-stage clinical trial now underway in the U.K. and other countries yields positive results. Learn More

The Federal Circuit is weighing a case that could deeply impact how drugmakers can patent biologics, an issue that is not only critical to coronavirus research but to biopharma at large. In Amgen v. Sanofi, the Federal Circuit will be deciding whether two Amgen patents claiming an entire genus meet enablement requirements under Section 112 of the Patent Act. The sparring drugmakers are fighting over whether broad claiming is needed to ensure companies can get coverage for discoveries that will lead to important drugs, or whether such broadness is unfairly shutting out competition and laying claim over antibodies they didn't actually discover. Learn More

Bristol Myers Squibb has entered into a definitive agreement to acquire Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. Forbius has developed a portfolio of highly selective and potent inhibitors of TGF-beta 1 & 3, which are key mediators of immunosuppression and fibrosis. The transaction, which is expected to complete in the fourth quarter subject to customary closing conditions, includes an undisclosed upfront payment and future success-based milestone payments. Learn More

From MIT Video Productions comes "From Controversy to Cure," a 57-minute documentary history of the birth and boom of the molecular biology and biotechnology industries in Cambridge and specifically Kendall Square. Today, the area is home to one of the largest clusters of biotechnology and pharmaceutical companies in the world, and is, according to this film, "on the front lines to defeat COVID-19." Not long ago, Kendall Square was a wasteland of vacant plants and empty space cleared away for a NASA electronics research center project that was killed by the Nixon administration as part of spending cuts demanded by the crippling costs of the Vietnam War. Learn More

Pfizer and BioNTech have said their COVID-19 vaccine could be ready for regulators to review by October and approved by the end of the year after releasing more favorable data from an early-stage trial. There are no vaccines approved for COVID-19 and governments across the world are striking deals with various manufacturers to get early access once regulators give them the rubber stamp. The latest data from a phase 1 study in the US showed that seven days after a second dose at 30 micrograms, the vaccine produced more neutralizing antibodies in those recovering from SARS-CoV-2 infection.Learn More

Three children with a rare neuromuscular disease have died after receiving a high dose of a gene therapy in a clinical trial run by Audentes Therapeutics. The first two deaths were disclosed in letters sent by the company to patient groups in June. Audentes reported the third in August. Each of the children suffered liver problems that ultimately led to fatal complications. The most recent death occurred this month, though the letters revealed Audentes halted dosing of new patients before anyone had died. The Food and Drug Administration subsequently placed the study on a formal clinical hold. Learn More

Bristol Myers Squibb has signed a 360,000 square- foot lease at 250 Water Street in Cambridge Crossing, the new and connected neighborhood at the intersection of Cambridge, Somerville, and Boston. The new building is currently under construction and is expected to be complete in late 2022. Bristol Myers Squibb plans to combine its Cambridge presence at the state-of-the-art laboratory and office building by the end of the first half of 2023. The site is a 43 acre parcel being developed to offer 2.1 million sq. ft. of state-of-the-art science and technology space and includes 11 acres of open space. Learn More

A US FDA emergency use authorization for blood plasma to treat Covid-19 is on hold, but could still be issued in the near future, Dr. H. Clifford Lane, deputy director at the National Institute of Allergy and Infectious Diseases, told The New York Times. The hold came after a group of federal health officials -- including National Institutes of Health Director Dr. Francis Collins, NIAID Director Dr. Anthony Fauci and Lane -- stepped in to argue the emerging data on the treatment was too weak, the Times reported, citing two senior administration sources. News of the hold led President Trump to suggest that it might be of a political nature and not based on science. Learn More

A novel way to control biologic signaling allows cellular function to be modulated via cell phone, according to research presented at the American Chemical Society's annual meeting this week by researchers at the University of Maryland. The technology relies on redox mediators, which shuttle electrons around cells. Redox mediators carry out cellular activities by accepting or giving up electrons through reduction or oxidation reactions. Because they can also exchange electrons with electrodes, thus producing a current, redox mediators can bridge the communications gap between electronics and living tissue, enabling electronics to control cells' behavior and enabling cellular feedback that could operate electronics. Learn More

Johnson & Johnson agreed to buy Momenta Pharma for roughly $6.5 billion this week to bolster its portfolio of drugs for hard-to-treat autoimmune diseases. The acquisition will provide J&J's Janssen unit with access to Momenta's experimental therapy, nipocalimab, which could potentially be used to treat a number of autoimmune diseases. J&J would also obtain Momenta's pipeline of clinical and pre-clinical assets. This deal brings the total number for 2020 to 829 compared to 839 this time last year. However, the value of this year's deals is much lower, $62 billion versus $290 billion. Learn More

The U.S. FDA has made public its decision to reject BioMarin's gene therapy for bleeding disorder hemophilia A citing the need for longer-term data, potentially pushing any approval out to 2022. News of the decision sent BioMarin shares down 31% in early trading. The company, Wall Street, and doctors had expected the therapy to be approved this month after it had shown in clinical trials that it reduced the bleeding rate of patients with the disorder, decreasing or eliminating the need for treatment. This decision is seen as an opportunity for competitors Roche and Pfizer who have their own development efforts underway. Learn More

Roche is adding its manufacturing muscle and global development expertise to Regeneron's bid to create an antibody cocktail for COVID-19 that the companies hope can be used to slow the pandemic. The collaboration gives Regeneron access to Roche's antibody production operations which in turn will boost overall capacity for REGN-COV2 by at least three and a half times. Under the terms of the arrangement Regeneron will handle U.S. sales while Roche will have responsibility for worldwide distribution. Alert readers will recall that Regeneron already has a deal in place with the U.S. government valued at $450 million to supply the cocktail. Learn More

Merck & Co., known in Europe as MSD to ensure no confusion with Merck of Germany, has made public plans to build a $1.3 Billion research hub in London. The site, which is rumored to be planning to be home to 800 people, will cover an area of roughly 270,000 sq. ft. (25,000 m2). According to published reports, the official name of the site will be the London Discovery Research Center with construction planned to commence in the latter part of next year. The schedule calls for Merck to occupy the site in 2025 with many of the early occupants being drawn from other Merck sites in and around London. Learn More

A U.S. district court upheld the validity of a patent for Swiss drugmaker Novartis' top-selling multiple sclerosis (MS) drug Gilenya, helping Novartis protect its blockbuster MS treatment from U.S. competition. The U.S. District Court for the district of Delaware said in a ruling dated Aug. 10 and unsealed this week that Novartis' patent was valid, rejecting a lawsuit from generic maker HEC that was backed by other generic drugmakers. HEC had submitted an ANDA to the U.S. FDA seeking approval to make a generic copy of Gilenya prior to the expiration of Novartis' patent, the court said in the ruling. Learn More

Eli Lilly has expanded a licensing deal with Innovent Biologics, giving the pharma most of the rights to a cancer immunotherapy the two have brought to market for a form of lymphoma in Innovent's home country of China. Lilly and Innovent had already split rights to the drug, Tyvyt, in China through a 2015 agreement. They'll continue to share those profits under the new deal, but Lilly now gains rights to Tyvyt everywhere else. Lilly paid Innovent $200 million upfront, and could hand over as much as $825 million more through additional milestone payments. The decision signals Lilly's interest in using Tyvyt to challenge more established immunotherapy competitors. Learn More

To the immune system, not all germs are equally memorable. But our body's cells seem to be seriously studying up on the coronavirus. Scientists who have been monitoring immune responses to the virus are now starting to see encouraging signs of strong, lasting immunity, even in people who developed only mild symptoms of COVID-19, a flurry of new studies suggests. Disease-fighting antibodies, as well as immune cells called B cells and T cells that are capable of recognizing the virus, appear to persist months after infections have resolved - an encouraging echo of the body's enduring response to other viruses. Learn More

Sanofi agreed to acquire US biotech company Principia Biopharma for about $3.4 billion as the French drug maker pivots toward innovative therapies to spur growth under new chief executive Paul Hudson. The all-cash deal will see Sanofi taking full control of the company, which focuses on treatments for multiple sclerosis and a range of autoimmune disorders, according to a statement. Bloomberg reported last month that Sanofi was studying potential acquisitions of US biotechnology firms, including Principia. Analysts say Sanofi has the firepower for more transactions. Learn More

Unity Biotechnology shares were off 61% this week after the drugmaker said its treatment for knee pain failed to meet a 12-week primary endpoint in a Phase II study. The company said in a statement that the study of UBX0101, its treatment for patients with moderate-to-severe painful osteoarthritis of the knee, found "no statistically significant difference between any arm of UBX0101 and placebo." Unity said it does not anticipate progressing UBX0101 into pivotal studies and will narrow the company's near-term focus to its ongoing ophthalmologic and neurologic disease programs. Learn More

The FDA plays a critical role in our nation's response to the COVID-19 pandemic. It helps decide which medicines are safe and effective to treat the disease. It evaluates the accuracy and reliability of laboratory tests. And it will play a central role in assessing potential vaccines. But will the FDA bureaucracy move with the kind of speed necessary to deal with such a crisis? Some critics are concerned it will not. Even before the rush of the pandemic, the Agency was accused of being slow to evaluate drugs; critics also complained that it denied access to life-altering medications for desperately ill patients. If it were still the 1970s, these criticisms would be well placed, but the FDA has made dramatic changes in the past four decades. Learn More

Russia may have become the first nation in the world to register the vaccine for novel coronavirus, but medical experts and health agencies around the globe are not entirely convinced of the safety and efficacy of the Russian vaccine. The World Health Organization has maintained that the Russian vaccine is NOT in the advanced stages of human trials (Phase III). As medical experts globally are already skeptical about the accelerated rate at which the Russian vaccine has been developed, Russia's own leading doctor has quit, criticizing the untested vaccine. Learn More

The United States is tying payments for COVID-19 vaccines to timing milestones for production and approval, according to public documents and a Trump administration official, putting pressure on drugmakers to meet ambitious targets. This sliding scale approach to payments is evaluating both the timing of regulatory clearance and the building out of industrial scale manufacturing capabilities, filings show. The deal terms add financial risk for the drugmakers and increase pressure for speed that has worried some public health advocates. Learn More

The Trump administration's coronavirus vaccine project is recruiting scientists in South Africa and Latin America to help test possible vaccines in U.S.- backed clinical trials, pledging to ease their countries' access to any successful products, Reuters has learned. Researchers in South Africa, Mexico, Brazil, Peru and Argentina are in discussions to join U.S. counterparts in conducting large-scale human trials of an experimental vaccine from Johnson & Johnson beginning next month, according to half a dozen government officials and scientists with knowledge of the effort. Learn More

Celleron Therapeutics has signed a licensing agreement with Roche for exclusive rights to emactuzumab, a monoclonal antibody and tumor microenvironment modulator. Roche has previously investigated the drug in combination with its other immunotherapy products, including PD-L1 inhibitor Tecentriq (atezolizumab), in solid tumour patients. Despite studying the drug across four trials, Roche ultimately shelved emactuzumab in 2018 in what it called a "business decision". Celleron has built a proprietary platform around epigenetic control and immune modulation, with it will no doubt use as it takes emactuzumab into the clinic. Learn More

Thermo Fisher has walked away from its takeover deal with Qiagen after the German genetic testing specialist's earnings were boosted by coronavirus diagnostics, leaving its shareholders reluctant to cash out. The U.S. lab equipment supplier's roughly $13 billion bid was scuttled when only 44% of Qiagen shares were tendered by this week's deadline, well short of the two thirds it needed. The failure to secure the required shares is being attributed largely to the successful efforts of an activist investor hedge fund to get the offer rejected. Learn More

Stem cell treatment maker Mesoblast's shares have plunged 30 per cent after the US FDA raised doubts about the effectiveness of the listed biotech's flagship product, which is being tested as a potential treatment for COVID-19. The US regulator's Oncologic Drugs Advisory Committee will meet today to consider evidence of the effectiveness of Mesoblast's remestemcel-L product for treating acute graft-versus host disease in children, a severe immune response which can occur after a bone marrow transplant. The product is also currently being trialed in the US as a treatment for patients suffering from acute respiratory distress due to COVID-19. Learn More

The U.S. government will pay as much as $1.5 billion to buy 100 million doses of Moderna's experimental coronavirus vaccine, securing supplies of a shot that it's helped to develop and advance quickly into late-stage clinical trials. Moderna has already benefited substantially from federal funding, which the company is using to pay for the recently started Phase 3 trial of its candidate in some 30,000 volunteers. Government scientists developed some of the technology that underpins the vaccine, and the National Institutes of Health led the initial human study.

NS Pharma announced this week that the U.S. FDA has approved VILTEPSO™ (viltolarsen) injection for patients with Duchenne Muscular Dystrophy (DMD). VILTEPSO received an accelerated approval by the FDA based on an increase in dystrophin, a key protein for supporting muscle health. The continued approval of VILTEPSO may be contingent on confirmation of a clinical benefit in a Phase 3 confirmatory trial. The most common side effects of VILTEPSO included upper respiratory tract infection, injection site reaction, cough and fever. NS Pharma is expected to compete directly with Sarepta. Learn More

Samsung Biologics has announced plans to break ground on a fourth manufacturing plant, the 'P4 Super Plant', this year and that it is in negotiations with local officials to purchase additional land for its second bio complex. The total size of the two investments is expected to be roughly $2 billion. Adding 256KL capacity to its site, Plant 4 is scheduled to commence manufacturing activities in the second half of 2022. The land under negotiation for Samsung Biologics' second bio complex measures 330,000 square meters. The company plans to create an Open Innovation center to foster biotech companies and build a global R&D facility in addition to securing space for future plants within the new complex. Learn More

Inspired by a unique kind of infection-fighting antibody found in llamas, a research team at the UCSF has synthesized a molecule that they say is among the most potent anti-coronavirus compounds tested in a lab to date. Called nanobodies because they are about a quarter of the size of antibodies found in people and most other animals, these molecules can nestle into the nooks and crannies of proteins to block viruses from attaching to and infecting cells. The lab-made one created by the UCSF team is so stable it can be converted into a dry powder and aerosolized, meaning it would be much easier to administer than Covid-19 treatments being developed using human monoclonal antibodies. Learn More

Ligand Pharmaceuticals and Pfenex are only about an eight-minute walk away from one another in San Diego's Sorrento Valley. And now, the two biotechs are about to get even closer. Ligand announced this week that it plans to acquire Pfenex for $438 million and will pay Pfenex shareholders an additional $78 million if Ligand hits an undisclosed milestone before December 2021. Ligand will now also have access to Pfenex's signature technology, which uses a special strain of bacteria to churn out complex proteins. Pfenex currently has 16 active partnerships, including collaborations with Merck, Jazz Pharmaceuticals and the Serum Institute of India. Learn More

Cloistered off a major thoroughfare, the Wuhan Institute of Virology could pass for a college campus, its red brick buildings distinguishable from their busy surroundings only by a long, imposing driveway lined with cameras, with a security guard standing sentry. On the neatly manicured grounds beside a small man-made lake is a newer structure with silver sidings and few windows. This, the institute's BSL-4 lab - the first in China to receive the highest level of biosafety clearance - stands at the center of an international firestorm of recrimination over China's role in the coronavirus pandemic. Recently, NBC News became the first foreign news organization to be granted access to the institute since the outbreak began. Learn More

A small biotech is worth more than four times what it was last week, thanks to a capsule filled with spores. Seres Therapeutics has become the first company to detail positive results from a pivotal study of a microbiome drug. The study looked at 182 patients with recurring infections from a bacterium called C. difficile, and found those who took Seres' capsule were significantly less likely to see their infections return. In fact, after eight weeks, nearly 90% of patients on the drug were without C. diff infections. Seres said the results provide enough support to submit its capsule for approval, putting the company in position to win the first-ever regulatory clearance for a microbiome-based drug. Learn More

The FDA is keeping its biologics labs shuttered far longer than other government research labs, according to internal FDA documents obtained by STAT. FDA officials told staff last month that it will keep the labs, which research ways to improve the safety of existing vaccines and gene therapies, closed until there are fewer than 10 coronavirus cases per 100,000 people in the counties surrounding the agency's White Oak, Md., campus. Currently, just 16 states meet that metric. Learn More

A deal that would have seen Eastman Kodak, perhaps best known for the film used in photography, receive funding in the amount of $765 million to produce drug ingredients that could have helped fight the coronavirus has been put on hold. In a recent announcement, the U.S International Development Finance Corporation said it was holding up the deal as regulators reportedly look into trading activity that sent Kodak's shares surging on news of the initial agreement. "We will not proceed any further unless these allegations are cleared," the DFC said. This comes amid reports that Congress has also expressed concerns about Kodak's lack of pharmaceutical experience. Learn More

The U.S. FDA will conduct an expedited review of an experimental Alzheimer's drug from Biogen and Eisai, the first application in 17 years to be reviewed by the agency for a treatment of the mind-robbing disease. If approved, aducanumab would be the first treatment designed to delay progression of Alzheimer's disease. The FDA agreed to a priority review with a decision expected by March 7th, 2021 the companies said, faster than the 10 months typically expected under a standard review. The companies added in a statement that the agency "has stated that, if possible, it plans to act early on this application." Learn More

Pfizer has signed a multiyear agreement to make COVID-19 treatment remdesivir for developer Gilead, which is under pressure to increase tight supplies of the antiviral drug. Gilead is aiming to make enough of the drug by the end of the year to treat more than 2 million COVID-19 patients and agreed to send nearly all of its remdesivir supply to the United States through September. Pfizer will provide contract manufacturing services through its McPherson, Kansas, plant, the drugmaker said. It was not immediately clear if Pfizer would supply only for the U.S. market. Gilead said its manufacturing network for the drug had grown to more than 40 companies in North America, Europe and Asia to add capacity. Learn More

Biogen and Denali Therapeutics have announced that they have signed a binding agreement to co-develop and co-commercialize Denali's small molecule inhibitors for Parkinson's disease. Under the terms of the agreement, Biogen will make an upfront payment to Denali of $560 million and make a $465 million equity investment in Denali from the purchase of 13.3 million newly issued shares of Denali shares. Should the program achieve certain development and commercial milestones, Denali will be eligible to receive up to $1.125 billion in potential milestone payments. Learn More

President Donald Trump has signed an executive order that would encourage the production of certain drugs and medical supplies in the U.S. following shortages during the Covid-19 pandemic. The order urges purchasers to buy American-made products and loosens federal drug-safety and environmental regulations that the administration says disadvantage domestic producers, among other measures. The drugs and devices covered by the order are expected to include medicines used to respond to a public-health emergency or biohazard attack, among others. The US FDA is tasked with coming up with the list of essential medicines covered by the order. Learn More

A Delaware district court judge has upheld two key patents covering Bristol Myers Squibb and Pfizer's blockbuster blood-thinning drug Eliquis. The judge ruled that generic versions of Eliquis from Sigmapharm, Sunshine Lake and Unichem infringe on composition of matter and formulation patents. Pending the outcome of any potential appeal, the companies wouldn't be able to launch copycat versions of the anticoagulant until 2031. The ruling is a significant victory for both companies, which share Eliquis sales through a 2007 alliance - particularly for Bristol Myers, for which the drug is a critical revenue driver. Learn More

The United States government will pay Johnson & Johnson over $1 billion for 100 million doses of its potential coronavirus vaccine, as it stocks up on vaccine and drugs in an attempt to tame the pandemic. J&J is studying both one and two-dose regimens of its vaccine and says it will deliver the vaccine to BARDA on a not-for-profit basis to be used after approval or emergency use authorization by the U.S. Food and Drug Administration (FDA). A further detail of the deal is that the U.S. government may also purchase an additional 200 million doses under a subsequent agreement, the cost of which has not been disclosed. Learn More

DBV Technologies may have a hard time overcoming its latest setback. This week the small French biotech announced that the US FDA had rejected its peanut allergy treatment because of design issues. The agency indicated the patch needs modifications and then more clinical data to prove it works - requests that could take years to address and further strain the already cash-strapped company. According to DBV, the agency couldn't approve the Viaskin Peanut desensitizing patch in its current form, due to concern the patch wouldn't be as effective if not fully adhered to the skin. Learn More

Sekisui is investing nearly $20 million (£14.4 million) in its biopharma CDMO business aimed at expanding cGMP microbial capacity at the existing site in Maidstone, Kent, UK to be completed by 2022. This investment is part of a long-term investment strategy to grow its share of the microbial biopharma CDMO market. The facility expansion and cGMP upgrades will enable Sekisui to take on drug substance contract manufacturing for clinical trials. The new cGMP certified microbial fermentation and purification suites will accommodate production scales up to 1,000L, complementing its existing capabilities which range from 20L to 5,000L fermentation scale. Learn More

The U.S. Department of Justice is demanding Purdue Pharma, maker of the infamous OxyContin opioid painkiller, pay more than $11 billion in criminal and civil penalties as part of its bankruptcy reorganization plan, according to people familiar with the claims. Federal prosecutors want Purdue to pay as much as $6.2 billion on the criminal side and about $5 billion in civil compensation for tax dollars spent battling the U.S. opioid epidemic and the havoc wreaked by allegedly illegal marketing of the drug, said the people who asked not to be identified because they're not authorized to speak publicly about the filing of the claims. Learn More