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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EU Accelerated Assessment Tracker: EMA To Fast Track Thalassemia Gene Therapy, New HIV Drug
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Finance Watch: Summer Heat Extends To Biopharma IPOs With Nine In July, 45 This Year
Public Company Edition: Nine more biopharma companies launched IPOs in the US in July, bringing the 2018 total to 45 first-time offerings – three more than in all of 2017. Bluebird's $632.5m offering leads recent follow-on public offerings.
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?