Biogen
NEWS
Biopharma leaders react to the forced resignation of CBER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; Novo Nordisk presents mixed results from oral semaglutide in cardiovascular disease; the EU’s Committee for Medicinal Products for Human Use declines to recommend Eli Lilly’s Alzheimer’s drug; and pharma R&D returns grew in 2024.
Since 2016, the FDA has approved three disease-modifying treatments for spinal muscular atrophy, with several companies—including Novartis, Scholar Rock and Biogen—progressing novel candidates through clinical trials.
Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
Biogen and Eisai have spent much of Leqembi’s launch convincing physicians and patients that it’s safe to treat Alzheimer’s disease. With patients now hitting the 18-month mark of treatment, the conversation is finally shifting to efficacy.
The funding agreement comes as Biogen revealed a modest Q4 sales beat, which analysts expect will be “overshadowed” by the company’s forecasted dip in 2025 revenues.
Leqembi’s sales in the U.S. continue to underwhelm, overshadowed by its growth in international markets.
Biogen’s effort to buy Sage against the board’s wishes and a long-time effort by investor Alcorn to scuttle Aurion’s IPO underscore the cutthroat nature of biopharma dealmaking.
The J.P. Morgan Healthcare Conference started off with a flurry of deals that reinvigorated excitement across the biopharma industry. Johnson & Johnson moved to acquire Intra-Cellular Therapies for $14.6 billion, breaking a dealmaking barrier that kept Big Pharma’s 2024 biotech buyouts to under $5 billion.
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