EU Fast-Track Fail For Another BMS CAR-T Cell Therapy
EMA Review Of Ide-Cel Reverts To Standard Timelines; Orva-Cel Development Program Scrapped
Bristol Myers Squibb says it is common for cell and gene therapies to revert to the standard timetable as ide-cel follows liso-cel in losing its accelerated assessment status at the European Medicines Agency. Separately, the company has discontinued development of orva-cel, a CAR-T cell therapy that was earlier in the development pipeline.
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The European Medicines Agency will decide this week whether BMS and bluebird bio’s cell-based gene therapy for multiple myeloma should be approved for use in the EU.
Bristol Myers Squibb's marketing application for liso-cel is in the final stages of the review process at the European Medicines Agency. The agency’s drug evaluation committee, the CHMP, adopted in mid-April the list of concerns it has with the application.
New medicines under evaluation at the European Medicines Agency.