Keep Us In The Loop: EMA Clarifies Expectations Following PRIME Kick-Off Meetings
Executive Summary
New guidance from the European Medicines Agency explains how sponsors that have drugs in its priority medicines scheme should interact with its experts and committees.
You may also be interested in...
EMA’s PRIME Is Driving Innovation, But Too Early To Tell If Drugs Will Reach Patients Faster
With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.