The Food and Drug Administration announced Friday that the prolonged shortage of Novo Nordisk’s popular medications Ozempic and Wegovy has been resolved after two and a half years of supply constraints. This development follows the FDA’s recent announcement regarding the end of shortages for Eli Lilly’s competing products, Mounjaro and Zepbound.
To ensure a smooth transition, the FDA has implemented a grace period for compounded versions of these medications. Compounded alternatives manufactured at state-licensed pharmacies will be permitted until April 22, while those produced at federally authorized outsourcing facilities have until May 22. The news significantly impacted Hims & Hers Health, a provider of compounded versions, whose shares dropped over 20% in Friday morning trading.
In other industry developments, Concentra Biosciences, backed by Tang Capital Partners, has launched an unexpected takeover bid for Acelyrin, which recently agreed to merge with Alumis. The proposal offers Acelyrin shareholders $3 per share in cash plus 80% of any future proceeds from potential licensing or sale of company programs. This contrasts with the current merger plan, which would give Acelyrin stockholders approximately 45% of Alumis shares, currently valued around $5 each.
Intra-Cellular Therapies reported strong performance for its psychiatric medication 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 United States, for treating primary biliary cholangitis. This approval comes six months after the FDA’s accelerated authorization. Gilead, which acquired the drug through its $4.3 billion purchase of CymaBay Therapeutics, is conducting confirmatory trials to secure full approval.
In pharmaceutical industry leadership news, Pfizer CEO Albert Bourla has been appointed as the new board chair of the Pharmaceutical Research and Manufacturers of America (PhRMA). Bourla, who has led Pfizer since 2019, succeeds Gilead Sciences CEO Daniel O’Day. The leadership transition includes Sanofi CEO Paul Hudson as chair-elect and Merck & Co.’s CEO Robert Davis as treasurer. Bourla emphasized his commitment to collaborating with policymakers to enhance healthcare accessibility and affordability.
Additionally, Incyte and Genesis Therapeutics have established 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 therapeutic areas remain undisclosed.
These developments reflect ongoing industry efforts to address drug supply challenges, advance treatment options, and leverage new technologies in pharmaceutical development. The resolution of the Ozempic and Wegovy shortages, in particular, marks a significant milestone in meeting the growing demand for metabolic medications, while new partnerships and leadership changes indicate continued evolution in the pharmaceutical sector’s approach to drug development and industry advocacy.