Month: June 2015

June 29, 2015
EMA validates Alprolix (rFIXFc) marketing authorisation application

26 June 2015The European Medicines Agency (EMA) has accepted Swedish Orphan Biovitrum AB (Sobi) and Biogen’s Marketing Authorisation Application for Alprolix (rFIXFc), a recombinant factor IX Fc fusion protein product for the treatment of haemophilia B. This validation effectively kicks off the EMA’s review process. The MAA is based on the results from two global, …

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