The Food and Drug Administration announced Friday that the lengthy shortage of popular weight loss and diabetes medications Ozempic and Wegovy has officially ended. The declaration comes after two and a half years of supply constraints for the Novo Nordisk-manufactured drugs, following a similar announcement regarding Eli Lilly’s competing medications Mounjaro and Zepbound.
To ensure a smooth transition, the FDA will temporarily allow compounded versions of these medications to remain available. Specifically, state-licensed pharmacies can continue manufacturing compounded alternatives until April 22, 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% in early Friday 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 offer includes $3 per share in cash plus 80% of 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. Acelyrin’s board is reviewing the proposal, with their Alumis merger originally scheduled to complete in Q2.
Intra-Cellular Therapies reported strong performance for their 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, attracted Johnson & Johnson’s attention, leading to a planned acquisition worth almost $15 billion expected to conclude this year.
In European markets, Gilead Sciences received conditional approval for seladelpar, marketed as Livdelzi in the U.S., for treating primary biliary cholangitis. The European Commission’s decision follows the FDA’s accelerated approval six months prior. Gilead, which acquired the drug through its $4.3 billion purchase of CymaBay Therapeutics, is conducting additional trials to secure full approval.
The Pharmaceutical Research and Manufacturers of America (PhRMA) announced new leadership, with Pfizer CEO Albert Bourla taking over as board chair from Gilead Sciences’ Daniel O’Day. Bourla, who has led Pfizer since 2019, emphasized the importance of collaboration with policymakers to enhance healthcare accessibility and affordability. Sanofi’s Paul Hudson was named chair-elect, while Merck & Co.’s Robert Davis will serve as treasurer.
Additionally, Incyte and Genesis Therapeutics have formed a new artificial intelligence partnership aimed at accelerating small molecule drug discovery. The collaboration includes an initial $30 million payment 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 resulting drug candidates, though specific therapeutic areas remain undisclosed.
These developments reflect ongoing efforts within the pharmaceutical industry to address supply chain challenges, advance drug development through strategic partnerships, and maintain strong market positions through mergers and acquisitions. The resolution of the Ozempic and Wegovy shortage particularly marks a significant milestone in meeting the growing demand for metabolic disorder treatments, while new leadership at PhRMA signals continued focus on industry advocacy and patient access to innovative therapies.