LentiGlobin Hogs The Limelight At CHMP’s First Amsterdam Meeting
An opinion on whether bluebird bio’s transfusion-dependent β-thalassemia gene therapy, LentiGlobin, should be granted an EU marketing authorization is due this week as the EMA’s key scientific committee, the CHMP, meets for the first time in Amsterdam.
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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.
March 1 saw the official departure of the European Medicines Agency for Amsterdam. The move from London, which is a result of the UK's decision to leave the EU, has caused huge upheaval for the agency, which has been in the UK capital since it was created in 1995.
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