BioPharma Dive - Latest News

Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicines outlined more RAS-blocking data and a Definium stock offering brought in $800 million.

Biotech investors, executives and analysts worry that blanket bans on deals with Chinese companies could curb domestic entrepreneurs’ ambitions in the sector.

Blair Jackson says the next 12 months may be the most important in Alkermes’ history, as the brain drugmaker races to join an “orexin” market that analysts see as a multibillion-dollar opportunity.

The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.

The transaction marks the latest turn in the fortunes of Passage Bio, one of the companies started by gene therapy pioneer Jim Wilson.