New EU Speedy Review Hopefuls: Novimmune, AveXis, bluebird bio, and Loxo Oncology
It is not easy for companies to convince the European Medicines Agency that their marketing applications merit accelerated assessment. Four new hopefuls are about to find out whether they have been successful.
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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?