The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.

There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted. 

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from, among others, Janssen, Sanofi, Boehringer Ingelheim and Mirum.

Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year. 

Janssen says the review at the European Medicines Agency of its marketing authorization application for cilta-cel reverted to standard timelines because the EMA wanted a GMP inspection and provision of a GMP certificate, "which did not allow continuation of the accelerated assessment timetable.”

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to experimental products from Atara, Calliditas, and Roche.