The Food and Drug Administration announced Friday that the prolonged shortage of Novo Nordisk’s popular weight loss and diabetes
medications Ozempic and Wegovy has been officially resolved. This development follows a similar announcement regarding Eli Lilly’s competing drugs Mounjaro and Zepbound, marking the end of a
two-and-a-half-year supply constraint that affected millions of patients.
To ensure a smooth transition, the FDA has implemented a grace period for compounded alternatives. State-licensed pharmacies can continue manufacturing these alternatives until April 22, while federally authorized outsourcing facilities have until May 22. This news triggered a significant market response, with Hims & Hers Health, a provider of compounded versions, experiencing a more than 20% decline in share value during Friday morning trading.
In corporate developments, Tang Capital Partners’ controlled entity Concentra Biosciences has launched an unsolicited takeover bid for Acelyrin, which recently agreed to merge with Alumis. The offer includes $3 per share in cash plus 80% of potential future proceeds from program licensing or sales. This proposal comes as an alternative to Acelyrin’s planned merger with Alumis, which would give
stockholders 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, representing a 47% increase from 2023. The drug, approved for schizophrenia and bipolar depression treatment, caught Johnson & Johnson’s attention, leading to a planned acquisition worth almost $15 billion.
European regulators have granted conditional approval to Gilead Sciences’ seladelpar, marketed as Livdelzi in the United States, for treating primary biliary cholangitis. The 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 confirmatory trials to secure full approval.
In industry leadership news, Pfizer CEO Albert Bourla has been appointed as the new chair of the Pharmaceutical Research and Manufacturers of America’s board, succeeding Gilead Sciences CEO Daniel O’Day. Sanofi’s Paul Hudson will serve as chair-elect, while Merck & Co.’s Robert Davis takes on the treasurer role. Bourla emphasized his commitment to working with policymakers to improve healthcare accessibility and affordability.
A new artificial intelligence collaboration has been established between Incyte and Genesis Therapeutics, aimed at accelerating small molecule drug discovery. The partnership involves an initial payment of $30 million to Genesis, with potential milestone payments reaching $295 million. Incyte will maintain development and commercialization rights for any successful drug candidates, though specific disease targets remain undisclosed.
This series of developments reflects ongoing dynamism in the pharmaceutical industry, from resolution of supply chain challenges to strategic corporate movements and technological advancement in drug development. The industry continues to evolve through mergers, acquisitions, and innovative partnerships while addressing critical healthcare needs and regulatory requirements. The resolution of the Ozempic and Wegovy shortage, in particular, represents a significant milestone in meeting growing demand for metabolic disorder treatments, while new leadership at PhRMA signals potential shifts in industry advocacy and policy engagement.