Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Maureen Kenny
Will the European Medicines Agency decide this week that Dova Pharmaceuticals’ eventual marketing authorization application for avatrombopag should be fast-tracked? If it does, the potential new thrombocytopenia therapy would join just a handful of products that are being reviewed under the EMA’s accelerated assessment pathway.
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.
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.
Nine marketing authorization applications, 15 variation of therapeutic indication requests, two requests for accelerated assessment and a re-examination procedure. These are some of items on the agenda at the latest meeting of the EMA’s key advisory panel, the CHMP, which is under way in London.
An unusually large number of companies are due to appear this week before the European Medicines Agency’s key advisory panel, the CHMP, to answer questions about initial marketing authorization applications or indication extension requests. The CHMP has questions regarding nine different products.