Conference Coverage

Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.

Meeting requests related to the Oncology Center of Excellence’s new dose optimization approach are increasing, along with sponsor questions, prompting the US FDA to determine how to clarify its intentions.

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

While not brandishing the name advocates have pushed for many years, the rare disease hub will play much the same role as a center of excellence in increasing collaboration between experts in the FDA drug and biologics centers.

The FDA does not appear likely to provide a calculation for sponsors to show clinical trial diversity, but agency officials seem split on how tough to enforce the new regulations intended to ensure all groups are adequately represented.

BIO CEO John Crowley sat down with Pink Sheet at the industry’s annual convention to discuss his vision for a newly restructured BIO, his thoughts on the upcoming US elections and whether he’d ever lead another biotech. 

Insights from Day Four of the BIO International Convention include FDA commissioner Califf on the state of real-world evidence and how it impacts IRA negotiations, Roche's interest in cardiovascular/metabolic assets, Merck's plans in immunology, and industry's rising interest in neuropsychiatry. 

Insights from Day Three of the BIO International Convention in San Diego include Amgen CEO Bob Bradway taking aim at the "Innovation Reduction Act," Novo Nordisk's business development head talking about spending its semaglutide bounty, Roivant's  long view on BD prospects for Immunovant's FcRn inhibitor, and more regulatory concerns around artificial intelligence. 

Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.

An FDA official said the agency is considering allowing MIDD meeting requests to be submitted more often, but must have a plan to deal with the likely increased demand.