New EU Market Hopefuls Await Their Fate; EMA Re-Adopting Zynteglo Opinion
Executive Summary
Sponsors of a raft of new products will find out this week if the European Medicines Agency’s medicines evaluation committee, the CHMP, is convinced the therapies are ready for marketing.
You may also be interested in...
EU Accelerated Assessment Tracker
Sanofi appears to have failed to convince the European Medicines Agency that its just-filed marketing authorization application for isatuximab should be granted accelerated assessment. AB Science's request regarding its planned MAA for masitinib has been rejected and Alnylam is declining to disclose the fate of its request relating to givosiran. See our latest updates in the tracker below.
EU Accelerated Assessment Tracker
Accelerated assessment requests at the European Medicines Agency.
ViiV’s Potential HIV Blockbuster Among Latest Drugs To Win EMA Nod
A total of 13 new drugs have been recommended for pan-EU approval, while one has failed to meet the European Medicines Agency’s standards.