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 resolved. This declaration comes after 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 compounds, while federally authorized outsourcing facilities have been given 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 any future licensing or sale proceeds. This competes with the existing merger plan that 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, caught Johnson & Johnson’s attention, leading to their recent $15 billion acquisition agreement.
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 additional trials to secure full approval.
In 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, while Sanofi’s Paul Hudson becomes chair-elect and Merck & Co.’s Robert Davis takes the treasurer position.
A new artificial intelligence partnership has been established between Incyte and Genesis Therapeutics, aimed at accelerating small molecule drug discovery. The collaboration includes 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 significant progress in addressing pharmaceutical supply chain challenges, advances in drug development and approval processes, and strategic industry partnerships. The resolution of the Ozempic and Wegovy shortage particularly marks a crucial turning point for patients requiring these medications for diabetes management and weight loss treatment. Meanwhile, the continued evolution of industry leadership and increasing integration of AI technology in drug discovery signals ongoing transformation in the pharmaceutical sector’s approach to healthcare innovation and delivery.