Sanofi and Novartis kick off the heart of earnings season; Lilly strikes its fourth pact in as many weeks; Regeneron earns landmark approval for a gene therapy for a type of genetic deafness, and also strikes a White House deal; FDA asks Amgen to withdraw Tavneos and, separately, issues Commissioner’s National Priority Vouches to three unnamed psychedelics companies.
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First quarter earnings are coming in at a rapid pace, with Sanofi and Novartis defending patents for Dupixent and Lutathera, respectively, and Sanofi welcoming Belén Garijo as CEO. Still to come this week are Eli Lilly, AstraZeneca, Regeneron and many more.
Lilly will undoubtedly discuss its recent streak of dealmaking; over the past two weeks, the obesity juggernaut has struck an up to $2.25 billion pact with AI biotech Profluent to find new genetic medicines, plus purchased Ajax Therapeutics and its next-gen JAK2 inhibitor for up to $2.3 billion and CAR T–focused Kelonia Therapeutics for up to $7 billion.
Meanwhile, Regeneron earned FDA approval for the highly anticipated gene therapy that will now be known as Otarmeni. It’s the first treatment to target an underlying cause of hearing loss, the first gene therapy approval for Regeneron, and the first gene therapy to not cause any serious adverse events in a clinical trial, according to one of the Phase 1/2 study’s investigators. The same day the approval came down, Regeneron also struck a deal with the White House, becoming the last of the 17 companies who received letters from the Trump administration last summer to officially sign on to the president’s Most Favored Nation drug pricing push.
Over at the FDA, controversy continues. First up, the agency has requested—again—that Amgen remove the autoimmune therapy Tavneos from the market. Specifically, the FDA says that unblinded study personnel manipulated results of the pivotal clinical trial that supported the drug’s approval to make it look more effective. But Amgen doubled down, insisting that Tavneos is safe and efficacious.
Separately, the FDA has issued three Commissioner’s National Priority Vouchers to unnamed psychedelic drug developers that BioSpace and others determined to be Compass Pathways, Otsuka (which now owns Transcend Therapeutics) and the Usona Institute. It is currently unclear why the FDA chose to withhold these details from its press release and declined to comment on the record when BioSpace requested additional information.
Finally, who will replace Vinay Prasad, the head of the agency’s Center for Biologics Evaluation and Research (CBER), who departs at the end of April after one year as the biologics chief?
