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A BioNTech spokesperson downplayed the news, insisting that the two companies remain “close” and have a “strong collaboration.”
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Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
Ensho Therapeutics CEO Neena Bitritto-Garg, recently named to BioSpace’s 40 Under 40, proved her mettle managing one of the toughest partnerships out there: the one between Eisai and Biogen that led to new Alzheimer’s drugs Aduhelm and Leqembi.
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.
Job Trends
Nearly $30 million in tax incentive awards are expected to add 1,519 new life sciences jobs in Massachusetts, with about 52% of the positions spread over Boston and Cambridge. Vertex, which received the largest award, will create hundreds of roles in Boston.
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If the attention generated by BioSpace’s coverage of this landmark approval is any indication, Americans are hungry for non-opioid pain treatments that could help quell the still raging opioid epidemic.
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Cogent Biosciences expects to file a new drug application for bezuclastinib in gastrointestinal stromal tumors early next year after what Leerink said was “the first positive trial in this disease in over a decade.”
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
Kezar Life Sciences suffered multiple clinical holds and four patient deaths in a trial testing zetomipzomib for lupus—a program that has since been canned. The company is still pursuing development in autoimmune hepatitis, but recent FDA communications could delay its timeline.
After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
The White House may have struck a deal with Eli Lilly and Novo Nordisk last week to lower the costs of their weight loss drugs for patients, but knockoff versions of Zepbound and Wegovy still permeate the obesity market.
MeiraGTx Holdings is licensing a genetic eye disease medicine to Eli Lilly in a deal worth up to $475 million.
Ionis is planning a supplemental submission by the end of the year to expand Tryngolza into severe hypertriglyceridemia. If granted, William Blair expects the antisense drug to be “transformational” for this indication.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
Eli Lilly has been on a dealmaking spree this year, with a few deals worth $1 billion or more. Aside from SangeneBio, these include SiteOne, Verve and Scorpion.
Multiple analyst firms were impressed by the Phase III data, which showed that Merck’s oral PCSK9 inhibitor can lower low-density lipoprotein cholesterol by more than 55% after 24 weeks.