BMS/bluebird’s Ide-Cel: EU Decision Time On First CAR-T For Multiple Myeloma
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.
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A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.
Sponsors of several new medicines, including the first ever CAR-T for multiple myeloma, will find out this week if their products are on track to get EU marketing authorizations. Also, three sponsors might be asked to address outstanding issues about their products in the final stages of review.
EU reviewers will decide this week whether to grant accelerated assessment to a handful of new dug candidates that will soon be filed for approval.