Decision Time At CHMP: Portola and Aegerion In Spotlight
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.
You may also be interested in...
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.
EU regulators meeting in London are finalizing the outstanding questions they have for companies whose products are approaching the final stages of the approval process.