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?
Just one of the seven requests for accelerated assessment that the European Medicines Agency has processed this year is known to have been successful. One request has been granted, four have been denied and the outcomes of two are unknown.
Decisions are due to be taken on a further four requests this week. Also see " New EU Speedy Review Hopefuls: Novimmune, AveXis, bluebird bio, and Loxo Oncology "...
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
