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EU Accelerated Assessment Tracker: EMA To Fast Track Thalassemia Gene Therapy, New HIV Drug

Executive Summary

Bluebird Bio’s LentiGlobin and Theratechnologies’ Trogarzo are both first of their kind treatments for transfusion-dependent β-thalassemia and HIV respectively.

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As the European Medicines Agency gets on with its fast-track review of bluebird bio's LentiGlobin gene therapy, the Pink Sheet takes a look at the year so far in the area of accelerated assessment. Daiichi Sankyo is keeping us guessing on whether its investigational new product, quizartinib, will also be fast-tracked once filed.

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EU Accelerated Assessment Tracker: Rejection Is Standard Outcome For Fast-Track Requests This Year

Attempts by companies to have their investigational products fast-tracked through the EU approval system this year so far have largely failed. Often the same products have or had priority review in the US. With the European Medicines Agency deciding on four new accelerated assessment requests this week, will the tide start to turn?

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