Scholar Rock’s Apitegromab Filing Exposes the CMO Due Diligence Gap That Keeps Burning Sponsors
Scholar Rock dropped Novo's Catalent plant from its SMA drug refiling after an OAI inspection. The compliance rot was...
Non-Small Cell Lung Cancer
Jazz and PharmaMar Just Ran Out of Runway: Zepzelca’s Confirmatory Failure Is an Accelerated Approval System Under Stress
Zepzelca's Phase 3 LAGOON trial missed overall survival in SCLC—Jazz's second confirmatory failure, six years after a 105-patient single-arm...