1. Pink Sheet

EU Accelerated Assessment Tracker

 
• By Maureen Kenny

Bayer has failed to convince the European Medicines Agency that its marketing authorization application for finerenone should be fast-tracked through the EU's centralized review process. There were other successes, though, although Janssen is keeping us guessing over its MAA for amivantamab. These and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.

The tracker below provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). It also tracks whether companies retain fast-track status for MAAs as they make their way through the EU centralized procedure.

This latest update reflects developments from November and December 2020.

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