EU Accelerated Assessment Tracker: EMA To Fast Track Thalassemia Gene Therapy, New HIV Drug
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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EU Accelerated Assessment Tracker: First Filing From Bluebird And Daiichi Keeping Mum
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.
OKs For 16 New Drugs But EMA Holds Firm On Betrixaban & Abaloparatide No
The European Medicines Agency this month recommended EU marketing approval for a raft of products, including what could become Europe's first two biosimilar versions of the blockbuster drug, Neulasta.
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?