The Food and Drug Administration has announced the end of a lengthy shortage of popular weight loss and diabetes medications from Novo Nordisk. The agency declared that supply constraints affecting Ozempic and Wegovy, which lasted approximately two and a half years, have been resolved as of Friday. This follows similar news regarding Eli Lilly’s competing products Mounjaro and Zepbound.
To ensure a smooth transition, the FDA is implementing a grace period for compounded versions of these medications. Pharmacies licensed at the state level have until April 22 to continue manufacturing these alternatives, while federally authorized outsourcing facilities have until May 22. This news significantly impacted Hims & Hers Health, a provider of compounded versions, whose shares dropped over 20% during Friday morning trading.
In other industry developments, Concentra Biosciences has made an unexpected offer to acquire Acelyrin, which recently agreed to merge with Alumis. The proposal from Concentra, controlled by Tang Capital Partners, includes $3 per share in cash plus 80% of proceeds from potential future licensing or sales of company programs. This offer comes as an alternative to Acelyrin’s planned merger with Alumis, in which stockholders would receive approximately 45% of Alumis shares.
Intra-Cellular Therapies reported strong performance for its mental health drug Caplyta, with net sales reaching nearly $681 million in the previous year, marking a 47% increase from 2023. The drug, approved for schizophrenia and bipolar depression treatment, caught Johnson & Johnson’s attention, leading to their recent agreement to acquire Intra-Cellular for approximately $15 billion.
European regulators have granted conditional approval to Gilead Sciences’ seladelpar, marketed as Livdelzi in the U.S., for treating primary biliary cholangitis. This approval follows the FDA’s accelerated authorization six months ago. Gilead, which acquired the drug through its $4.3 billion purchase of CymaBay Therapeutics, is conducting additional trials to secure full approval.
In leadership news, Pfizer CEO Albert Bourla has been appointed as chair of the Pharmaceutical Research and Manufacturers of America’s board, succeeding Gilead Sciences CEO Daniel O’Day. Bourla expressed his commitment to collaborating with policymakers to enhance healthcare accessibility and affordability. The organization’s leadership team now includes Sanofi CEO Paul Hudson as chair-elect and Merck & Co.’s CEO Robert Davis as treasurer.
Additionally, Incyte and Genesis Therapeutics have formed a new artificial intelligence partnership aimed at accelerating small molecule drug discovery. The collaboration involves an initial payment of $30 million to Genesis, with potential additional payments of up to $295 million based on achievement of specific milestones. Under the agreement, Incyte will maintain development and commercialization rights for any successful drug candidates, though specific disease targets remain undisclosed.
These developments reflect ongoing changes in the pharmaceutical industry, from supply chain improvements to strategic partnerships and leadership transitions. The resolution of the Ozempic and Wegovy shortage particularly marks a significant milestone for patients requiring these medications, while new collaborations and acquisitions continue to shape the industry’s future direction.