PhRMA sued CMS on October 7 over the GLOBE most-favored-nation rule for Medicare Part B. The final rule covers as few as four manufacturers and $440 million in projected savings. The suit's real target is the CMMI test authority beneath it.
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KRAS sat on the undruggable list for decades. Silexion's SIL204 is built to silence the mutation earlier in the cell, and the Phase 2/3 program is now moving into patients.
Mirum's brelovitug hit its Phase 3 endpoint in hepatitis delta, but Gilead's Hepcludex already holds the US approval and Vir's program is in flight. A strong readout no longer guarantees the market follows.
Lilly's once-weekly insulin Onswik is the second FDA approval in a six-month window, after Novo's Awiqli. Both won on non-inferiority data, leaving the real question open: whether weekly dosing actually improves insulin initiation and adherence.