An FDA advisory panel recommended use of an experimental Replimune treatment for advanced melanoma that the agency has rejected twice
And so, another working week will soon come to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we plan on promenading with the official mascots, catching up on our reading, and manicuring the Pharmalot campus. We also hope to hold still another listening party, where the rotation will likely feature this, this, this, this and this. And what about you? If the weather cooperates, the possibilities are endless — hiking, surfing, sunbathing, strolling, gazing at the stars in the sky. Maybe you want to try a new restaurant. You could also do something meaningful and reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
A U.S. Food and Drug Administration advisory panel voted 10-to-3 to recommend use of an experimental Replimune treatment for advanced melanoma, STAT writes. The panel determined the company collected sufficient data to allow the FDA to review RP1, an engineered viral immunotherapy. What comes next could be seen by some as a signal of how the FDA, which is under new leadership, weighs potential benefits and risks for investigational drugs. RP1 was initially rejected last year and again this past April. Investors have interpreted the decision to hold an advisory committee meeting as a sign of new lenience.
The weight loss drug boom is beginning to show signs of a slowdown as employers and insurers pull back on coverage, signaling the market could be entering a more restrained phase after years of breakneck expansion, Bloomberg News says. In the past few months, growth in prescriptions for GLP-1 drugs for weight loss have moderated, according to Cigna chief executive officer Brian Evanko. The insurer’s pharmacy benefits manager has seen coverage declines and slower utilization growth compared to prior periods. About 6% of big employers dropped coverage for the drugs in 2026, according to a recent survey from consulting firm Mercer.