New Filings At The EMA
Executive Summary
New medicines under evaluation at the European Medicines Agency.
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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.
CHMP Delays Review of Portola's Ondexxya; Who Will Pass Muster?
With its final meeting of the year under way, the EMA's medicines evaluation committee, the CHMP, will bring seasonal cheer for some companies if it decides their products merit EU approval. New treatments from Shionogi and Medac are up for an opinion. A planned appearance by Portola before the panel to answers questions relating to its marketing application for Ondexxya/AndexXa has been cancelled and the review period for the marketing authorization application for the product extended.
EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions
After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.