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Today, a brief rundown of news involving Novo Nordisk, Acelyrin and Intra-Cellular Therapies, as well as updates from Gilead Sciences and PhRMA that you might have missed.
The Food and Drug Administration has declared a two-and-a-half year shortage of Novo Nordisk’s metabolic drugs Ozempic for diabetes and Wegovy for obesity to be “resolved,” as of Friday. The decision follows the FDA’s declaration of an end to shortages for Eli Lilly’s competing drugs Mounjaro and Zepbound. The two companies have struggled with capacity as demand for the drugs has soared, particularly in obesity. To ensure supplies of compounded alternatives of the Novo drugs aren’t disrupted, the FDA said it won’t enforce any bans on those products until April 22 if manufactured at a state-licensed pharmacy or May 22 if they’re made at a federally authorized outsourcing facility. Shares in Hims & Hers Health, which has marketed compounded versions of the drugs, fell by more than 20% in Friday morning trading. — Jonathan Gardner
Concentra Biosciences, an entity controlled by investment firm Tang Capital Partners, has made an unsolicited bid for Acelyrin weeks after the company agreed to merge with fellow immune drug developer Alumis. Through the offer announced Thursday, Concentra intends to acquire Acelyrin for $3 per share in cash as well as the right to 80% of the proceeds if Concentra licenses or sells the company’s programs. Acelyrin stockholders would get about 45% of Alumis’ shares — which currently trade around $5 apiece — in the planned merger. Acelyrin said its board will act in “the best interests of all stockholders” and it will make a further announcement “in due course.” If approved by shareholders, its merger with Alumis would close in the second quarter. — Ben Fidler
Intra-Cellular Therapies, maker of the mind-stabilizing medicine Caplyta, reported on Friday that net sales of the product totaled almost $681 million last year. That sum is up 47% compared to 2023. Caplyta is already approved in the U.S. as a treatment for schizophrenia and bipolar depression, and could be cleared in major depression before too long. Sensing the drug’s blockbuster potential, Johnson & Johnson recently agreed to acquire Intra-Cellular for nearly $15 billion. The deal is expected to close later this year. — Jacob Bell
European regulators have granted conditional authorization to Gilead Sciences’ seladelpar in primary biliary cholangitis, a rare autoimmune condition of the liver. The European Commission’s decision follows by six months the Food and Drug Administration’s decision to grant accelerated authorization to the drug, which Gilead sells as Livdelzi in the U.S. Testing showed seladelpar reduced levels of a liver enzyme that is elevated in PBC patients. To gain full approval, Gilead is working on a confirmatory trial designed to show seladelpar can reduce PBC-related complications in people with the condition and compensated cirrhosis. The company gained the drug in its $4.3 billion acquisition of CymaBay Therapeutics. — Jonathan Gardner
Pfizer CEO Albert Bourla has assumed the role of chair of the Pharmaceutical Research and Manufacturers of America’s board. Bourla, who has been Pfizer’s CEO since 2019, said he wants drugmakers’ biggest lobbying group to work with policymakers to “address the burden of chronic disease and other devastating conditions, improve patients’ lives, and ensure lifechanging medicines are available and affordable for people who need them.” Bourla will take PhRMA’s reins from Gilead Sciences CEO Daniel O’Day. Sanofi CEO Paul Hudson was elected as PhRMA’s chair-elect and Merck & Co.’s CEO Robert Davis will serve as treasurer.— Jonathan Gardner
Incyte and Genesis Therapeutics are teaming up on an AI collaboration the companies said will help them find new small molecule drug candidates more quickly. Announced Thursday, the deal hands Genesis $30 million upfront with the potential for $295 million more upon hitting certain milestones. If successful, Incyte retains the rights to develop and commercialize any drugs that emerge from the partnership. Neither company said which disease area would be pursued first. — Gwendolyn Wu
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