European CHMP Opinions And MAA Updates
Executive Summary
This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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Fremanezumab Among Latest EU Drug Hopefuls While Patients Speak Up On Pacritinib
Marketing applications for Teva’s migraine prevention CGRP inhibitor, fremanezumab, and CTI BioPharma’s myelofibrosis treatment, pacritinib, are among a number of submissions scheduled for discussion this week by the European Medicines Agency’s drug evaluation committee, the CHMP.
42 New Substances Among 84 EU Approval Recommendations In 2018
The EMA’s CHMP recommended EU marketing authorization for a total of 84 new drugs in 2018, containing a total of 42 new active substances. They included the EU’s first two CAR-T cell therapies, Kymriah and Yescarta, which were also among the 21 orphan medicines to gain a positive opinion from the committee.
Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations
Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP. Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn an application for another.