The Food and Drug Administration announced Friday that the lengthy 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 has affected patients nationwide.
To ensure a smooth transition, the FDA has implemented a grace period for compounded alternatives. Pharmacies licensed at the state level will have until April 22 to continue manufacturing these alternatives, while federally authorized outsourcing facilities have been granted an extension until May 22. This news significantly impacted Hims & Hers Health, a provider of compounded versions, whose shares dropped more than 20% during 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 potential future licensing or sale proceeds. 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 mental health medication 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 given conditional approval to Gilead Sciences’ seladelpar, marketed as Livdelzi in the United States, for treating primary biliary cholangitis. The authorization comes six months after FDA approval, with Gilead currently conducting
confirmatory trials to demonstrate the drug’s effectiveness in reducing PBC-related complications.
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, expressed his commitment to collaborating with policymakers to enhance healthcare accessibility and affordability. He succeeds Gilead Sciences CEO Daniel O’Day, with Sanofi’s Paul Hudson named as chair-elect and Merck & Co.’s Robert Davis taking the treasurer position.
Additionally, Incyte and Genesis Therapeutics have announced a new artificial intelligence collaboration aimed at accelerating small molecule drug discovery. The partnership involves an initial payment of $30 million to Genesis, with potential additional payments of up to $295 million based on achievement of specific milestones. While the specific disease focus remains undisclosed, Incyte will maintain development and commercialization rights for any successful drug candidates emerging from the collaboration.
These developments reflect significant progress in addressing pharmaceutical supply chain challenges, advancing treatment options for various conditions, and strengthening industry leadership structures. The resolution of the Ozempic and Wegovy shortage particularly marks a crucial milestone for patients requiring these medications for diabetes management and weight loss treatment, while the various corporate movements and regulatory approvals demonstrate the industry’s continued evolution and innovation in addressing global health challenges.