FDA
CEO Stéphane Bancel expressed confidence in Moderna’s first quarter, touting the revenue numbers as a sign of the company’s return to prosperity.
Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.
Members of the FDA’s Oncologic Drugs Advisory Committee questioned the design of AstraZeneca’s Phase 3 trial of camizestrant, which involved switching treatments at the point of mutation detection, as opposed to the current practice of changing regimens upon disease progression.
Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.
UniQure plans to submit AMT-130 to the U.K.’s Medicines and Healthcare products Regulatory Agency in the third quarter of 2026 based on Phase 1/2 data showing a 75% slowing of disease—the same data the FDA has deemed unacceptable for a biologics license application.
While some analysts consider the return of advisory committees a positive sign for the FDA—and the biopharma industry more widely—others are keeping their optimism in check, waiting instead for more foundational changes at the regulator.
In briefing documents released Wednesday, the FDA raises doubts about two AstraZeneca assets set to be discussed Friday at the agency’s first drug-related advisory committee meeting in nine months.
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.
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
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