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Bluebird Bio's Zynteglo Flies Through Its CHMP Review

Executive Summary

A nod in record time from the European Medicines Agency’s CHMP for its beta-thalassemia gene therapy Zynteglo pushes bluebird bio out of the nest and into commercial territory.

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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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