First quarter earnings reports are arriving quickly as major pharmaceutical companies announce results and leadership changes. Sanofi and Novartis are defending patents for Dupixent and Lutathera, while Sanofi has named Belén Garijo as its new chief executive officer. Additional earnings from Eli Lilly, AstraZeneca, Regeneron and others are expected later this week.
The wave of activity comes at a time of significant dealmaking in the industry. Eli Lilly has entered into several agreements recently. In the past two weeks, the company announced an agreement worth up to $2.25 billion with artificial intelligence biotech Profluent to develop new genetic medicines. Lilly also acquired Ajax Therapeutics for up to $2.3 billion and Kelonia Therapeutics for up to $7 billion.
Regeneron has received approval from the United States Food and Drug Administration (FDA) for Otarmeni, a gene therapy that targets an underlying cause of hearing loss. This marks both Regeneron's first gene therapy approval and the first such treatment not associated with serious adverse events in clinical trials, according to one of the Phase 1/2 study investigators. On the same day as this regulatory milestone, Regeneron signed on to the White House's Most Favored Nation drug pricing initiative after receiving a letter from the previous administration last summer.
Meanwhile at the FDA, scrutiny continues over Amgen's autoimmune therapy Tavneos after agency officials requested again that it be removed from market due to concerns about manipulated clinical trial data by unblinded personnel intended to make results appear more favorable. Amgen maintains that Tavneos remains safe and effective.
In another development, three Commissioner’s National Priority Vouchers were issued by the FDA to unnamed psychedelic drug developers identified by BioSpace as Compass Pathways, Otsuka (now owner of Transcend Therapeutics), and Usona Institute; however, reasons behind withholding these names have not been clarified by regulators despite requests for comment.
Looking ahead at leadership transitions within federal agencies overseeing biologic drugs: The head of FDA’s Center for Biologics Evaluation and Research (CBER), Vinay Prasad, is set to depart at month’s end after one year in his role.
