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New Filings At The EMA

Executive Summary

New medicines under evaluation at the European Medicines Agency.

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Five New EU Filings Leave Starting Blocks at EMA

There is one orphan drug among the five new marketing authorization applications that the European Medicines Agency has under review. All five drugs will be reviewed under standard review timelines.

EU Fast-Track Fail For Another BMS CAR-T Cell Therapy

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.

EU Accelerated Assessment Tracker

Global Blood Therapeutics' EU marketing application for Oxbryta (voxelotor) will undergo standard review once it is filed after the company failed to secure fast-track status for the sickle cell disease treatment. Only one product was granted accelerated assessment in October and November.

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