viernes, 5 de octubre de 2018

Bluebird Bio's beta thalassemia gene therapy already under review in Europe - STAT

Bluebird Bio's beta thalassemia gene therapy already under review in Europe - STAT

The Readout

Bluebird's fast flight in Europe

Surprise! Bluebird Bio’s beta-thalassemia gene therapy is already under review in Europe.

Earlier this morning, the Cambridge biotech said a marketing application for Lentiglobin to treat patients with the rare, inherited blood disease was accepted for review by European regulators.

Bluebird was sneaky — in a good way. Based on the company’s prior guidance, investors were expecting Bluebird to announce a European regulatory filing before the end of the year. Instead, Bluebird went ahead and submitted the Lentiglobin gene therapy without telling anyone. Friday's public announcement means the European review process for Lentiglobin is ahead of schedule.

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