EU Approvals In Sight For Novartis, Roche, and Janssen
CHMP Gives Thumbs Up To Alpelisib, Entrectinib, Ebola Vaccines
EU approval is a formality for the eight products given the nod this week at the European Medicines Agency. There's no word, though, on filgotimid, from Gilead/Galapagos.
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Piqray is now approved for use in almost 50 countries but not only did the novel drug from Novartis for advanced breast cancer take longer to be approved in the EU than in the US, its indication is narrower in the EU. This is the first of two articles based on the European public assessment report for the PIK3 inhibitor.
GlaxoSmithKline's potential multiple myeloma treatment is one of several new products that could get an EU marketing thumbs up from the European Medicines Agency this week.
The two-part vaccine becomes the second against Ebola to get approval. Janssen is now collaborating with the World Health Organization on vaccine pre-qualification to get it to people in need.