Another Ebola Vaccine Among New Filings At EMA
Four New EU Marketing Applications Granted Fast-Track Status
Executive Summary
The European Medicines Agency has received 11 new marketing authorization applications, including three for orphan products from Vertex, MYR Pharmaceuticals and AstraZeneca.
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EU Accelerated Assessment Tracker
GSK secured accelerated assessment for dostarlimab at the European Medicines Agency but there was no such good news for Merck/AstraZeneca's selumetinib. MYR Pharmaceuticals' bulevirtide has reverted to standard review timelines.
EU Fast-Track Loss For Vertex’s CF Triple Combo
Vertex is hoping for EU approval in Q4 of its cystic fibrosis triple combination therapy, Trikafta. It wants the same licence in the EU as it has in the US, where the product has already become a best seller for the company.
EU Accelerated Assessment Tracker
The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.