Eight New Filings At EMA: Three Granted Fast Track Status
Executive Summary
New EU marketing applications from Novimmune, Theratechnologies/TaiMed Biologics and Loxo Oncology have all been granted accelerated assessment by the European Medicines Agency.
You may also be interested in...
EU Accelerated Assessment Tracker: First Filing From Bluebird And Daiichi Keeping Mum
As the European Medicines Agency gets on with its fast-track review of bluebird bio's LentiGlobin gene therapy, the Pink Sheet takes a look at the year so far in the area of accelerated assessment. Daiichi Sankyo is keeping us guessing on whether its investigational new product, quizartinib, will also be fast-tracked once filed.
New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
CHMP Preview: Lilly, Merck and Bayer Hopeful On Approvals; Sarepta’s Exondys Appeal Result Due
The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.