Roctavian’s Durability: For The Price, Payers Wanted Longer-Term Proof Anyway
FDA’s decision to seek two more years of data for BioMarin’s gene therapy for hemophilia A ‘makes perfect sense,’ Harvard Pilgrim Health Care’s Michael Sherman says.
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Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.
BioMarin’s confidence that its first-ever hemophilia gene therapy would be cleared by the US FDA was shaken by a complete response letter that the company claims changed the requirements for approval.
Hemlibra could save health care system $1.85m per patient annually as it displaces current approaches to treatment, Institute for Clinical and Economic Review projects in draft report.