Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
Boston’s biotech identity is under pressure as founders decamp for California, Alzheimer’s researchers uncover more secrets of tau function, and Replimune finally secures a hard-fought FDA approval.
Soundtrack of this Readout: This “abstract funk from the turn of the century” playlist. Also quite useful while breaking down cardboard boxes and covertly tossing kid art projects.
Replimune finally wins battle for FDA approval
After two rejections and an extraordinary third review, the FDA has granted accelerated approval to Replimune’s melanoma therapy RP1 — a decision that suggests regulators are applying a more flexible approach to cancer drug reviews, despite lingering concerns from FDA staff about the underlying data. The list price of the drug, Tudriqev, will be $450,000 per course of therapy before rebates and discounts.
