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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

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