STAT+: Pharmalittle: We’re reading about Replimune’s melanoma drug, a Medicare policy change, and more

The U.S. Food and Drug Administration recently approved the treatment for advanced melanoma, a significant victory for the biotech company Replimune following a difficult approval process. This approval came after FDA advisers voted in favor of the treatment, Tudriqev, despite concerns over the trial design and conduct. The majority felt there was sufficient evidence of efficacy and that patients urgently needed new treatments.

However, a little-known policy change by Medicare inadvertently caused a seven-year delay in negotiating a price for a costly AbbVie medicine. This decision, made by the Centers for Medicare and Medicaid Services (CMS) before they entered price negotiations, ultimately benefited AbbVie and potentially other drugmakers.