Clovis Confident, Portola Not: CHMP Decides On EU Marketing Applications
Eight EU marketing authorization applications are up for an opinion this week from the CHMP, the European Medicines Agency committee that recommends whether or not products should be approved.
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The European Medicines Agency asks companies to wait until they know for certain whether their marketing authorization applications will be approved or not before making any public announcement. Despite this, some companies go public as soon as they hear an early, but non-binding, verdict. The Pink Sheet looks at the issue of “trend votes” and at the companies who decide not to wait.
The EMA is finally set to approve Pfizer's targeted anticancer Mylotarg for use in acute myeloid leukemia. The company also received opinions for Bosulif and Sutent.
The EU’s CHMP has recommended approval of a number of products including Pfizer’s Mylotarg for acute myeloid leukemia, Ammtek’s Amglidia for neonatal diabetes, and BioCryst Pharmaceuticals/Seqirus’ Alpivab for uncomplicated influenza.