Replimune
Coverage of Replimune in the Nexus archive.
- STAT+: Pharmalittle: We’re reading about a Novo setback, support for Replimune’s melanoma drug, and more
An FDA advisory panel recommended Replimune's experimental melanoma drug RP1 after a 10-3 vote, but the weight loss drug market shows signs of slowing as employers and insurers reduce coverage. The FDA's new leadership is being observed for its approach to evaluating investigational drugs.
- FDA advisory panel backed Replimune's twice-rejected melanoma treatment in 10-3 vote
The FDA advisory panel supported Replimune's melanoma treatment RP1 in a 10-3 vote, increasing its chances of approval before the Aug. 2 deadline. RP1 is an engineered viral immunotherapy previously rejected by the FDA.
- STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
FDA staff have reiterated concerns about insufficient data to support approval of Replimune’s investigational skin cancer treatment RP1. The agency criticized a single-arm trial combining RP1 with Opdivo, arguing it fails to establish the drug’s efficacy or systemic benefits, while Replimune claims ethical and feasibility challenges prevent a placebo-controlled study.
- FDA Blocked Melanoma Drug as Confusion Reigned Under Makary
The FDA's decision to withhold approval of a new skin cancer treatment has been met with criticism from doctors and patients, with some citing concerns about the agency's changed culture under Commissioner Marty Makary. The treatment, called RP1, had shown promise in prolonging the lives of some patients. The FDA's decision has raised questions about the agency's standards and processes.
- US Premarket Movers: Baker Hughes, Goldman, Leggett, Replimune
The article highlights premarket stock movements involving Baker Hughes, Goldman Sachs, Leggett, and Replimune. It mentions Goldman Sachs' signage at the New York Stock Exchange floor, indicating market activity.