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 officially ended after two and a half years. This development follows the FDA’s recent declaration that shortages of Eli Lilly’s competing medications, Mounjaro and Zepbound, have also been resolved. Both pharmaceutical companies had struggled to meet soaring demand, particularly for obesity treatments.
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 these 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 more than 20% during Friday morning trading.
In other industry developments, Tang Capital Partners’ controlled entity Concentra Biosciences has made an unexpected offer to acquire Acelyrin. The proposal comes shortly after Acelyrin had agreed to merge with Alumis, a fellow immune drug developer. Concentra’s offer includes $3 per share in cash plus 80% of any proceeds from potential licensing or sales of Acelyrin’s programs. Under the previously planned merger with Alumis, Acelyrin shareholders would receive approximately 45% of Alumis shares, currently valued around $5 each. Acelyrin’s board is reviewing the proposal.
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 medication, approved for schizophrenia and bipolar depression treatment in the United States, caught Johnson & Johnson’s attention, leading to their recent agreement to acquire Intra-Cellular for approximately $15 billion.
Meanwhile, Gilead Sciences received conditional authorization from European regulators for seladelpar, marketed as Livdelzi in the U.S., to treat primary biliary cholangitis. This approval follows the FDA’s accelerated authorization granted 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 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 improve healthcare accessibility and affordability. He succeeds Gilead Sciences CEO Daniel O’Day, while Sanofi CEO Paul Hudson was named chair-elect and Merck & Co.’s CEO Robert Davis will serve as treasurer.
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 certain 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 ongoing industry efforts to address drug shortages, advance treatment options, and leverage new technologies in pharmaceutical research and development, while also highlighting significant corporate movements and leadership changes within the sector.