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 declaration comes after more than two years of supply constraints and follows a similar announcement regarding Eli Lilly’s competing drugs Mounjaro and Zepbound.
To ensure a smooth transition, the FDA will temporarily continue allowing compounded versions of these medications. 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% during Friday morning trading.
In other industry developments, Concentra Biosciences, backed by Tang Capital Partners, has launched an unexpected takeover attempt of 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 contrasts with the current merger plan, which would give Acelyrin stockholders approximately 45% ownership in Alumis, whose shares currently trade around $5.
Intra-Cellular Therapies reported strong performance for its mental health drug 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, has attracted Johnson & Johnson’s attention, leading to a planned acquisition worth almost $15 billion expected to conclude this year.
European regulators have given conditional approval to Gilead Sciences’ seladelpar, marketed as Livdelzi in the United States, for treating primary biliary cholangitis. This 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, succeeds Gilead Sciences CEO Daniel O’Day. The organization’s leadership team will also include Sanofi CEO Paul Hudson as chair-elect and Merck & Co.’s CEO Robert Davis as treasurer. Bourla expressed his commitment to collaborating with policymakers to improve healthcare accessibility and affordability.
Additionally, Incyte and Genesis Therapeutics have formed a new artificial intelligence partnership 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 ongoing industry efforts to address drug shortages, advance treatment options, and leverage new technologies in pharmaceutical development. The resolution of the Ozempic and Wegovy shortage particularly marks a significant milestone in addressing the growing demand for weight loss and diabetes medications, while strategic partnerships and leadership changes indicate continued evolution in the pharmaceutical sector’s approach to drug development and patient care.