EU Accelerated Assessment Tracker: Rejection Is Standard Outcome For Fast-Track Requests This Year
Executive Summary
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?
You may also be interested in...
EU Accelerated Assessment Tracker: Second Half Trumps First By Far
The first half of the year was pretty bleak for companies seeking fast-track review of their products in the EU. There has been much better news in the second half. The Pink Sheet tracks the winners and losers.
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.
Eight New Filings At EMA: Three Granted Fast Track Status
New EU marketing applications from Novimmune, Theratechnologies/TaiMed Biologics and Loxo Oncology have all been granted accelerated assessment by the European Medicines Agency.