EU Accelerated Assessment – Hard To Get, Hard To Keep
Executive Summary
It’s hard enough in the first place for companies to persuade the European Medicines Agency that their planned marketing authorization application should be fast-tracked. Many are also finding that after accelerated assessment is granted, it is taken away during the actual review.
You may also be interested in...
EMA Crunch Time For Shionogi’s Novel Antibiotic Cefiderocol
The EU marketing application for cefiderocol that lost fast track status last July is now up for an opinion by the European Medicines Agency.
EU Fast-Track Loss For Vertex’s CF Triple Combo
Vertex is hoping for EU approval in Q4 of its cystic fibrosis triple combination therapy, Trikafta. It wants the same licence in the EU as it has in the US, where the product has already become a best seller for the company.
EU Accelerated Assessment Tracker
The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests:
