The FDA has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of Biogen Idec‘s BLA for Alprolix, the company’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B. The PDUFA date has been extended by three months, which is the standard extension period. In response to a request from FDA, Biogen Idec submitted additional information related to the validation of a manufacturing step for Alprolix. Due to the timing of ...