EU Hat Trick For Bluebird’s Beta-Thalassemia Gene Therapy
bluebird bio is set to enter the EU market with the first gene therapy for transfusion-dependent β-thalassemia, after the European Medicines Agency reviewed its product in record time. Bluebird believes that the agency’s Priority Medicines (PRIME) and adaptive pathways programs have been instrumental in smoothing its path.
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Sponsors of a raft of new products will find out this week if the European Medicines Agency’s medicines evaluation committee, the CHMP, is convinced the therapies are ready for marketing.