Baxter International has filed an application to the US Food and Drug Administration (FDA) for a pediatric indication for Rixubis [Coagulation Factor IX (Recombinant)] to treat hemophilia B. The submission was based on a Phase II/III ...
Biogen Idec announced that the US Food and Drug Administration (FDA) has extended its review of a marketing application for the long-lasting recombinant factor IX Fc fusion protein Alprolix for haemophilia B by three months. The company ...
Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval of Rixubis, recombinant factor IX for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B. ...
Tags: Baxter, European Medicines Agency
RNAi therapeutics company Alnylam Pharmaceuticals has obtained additional orphan drug designation from US FDA for a RNAi therapeutic, ALN-AT3, to treat hemophilia A. With the additional approval, orphan drug designation for GalNAc ...
Tags: Alnylam, Orphan Drug
The US Food and Drug Administration (FDA) has accepted Biogen Idec's biologics license application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. Using the company's ...
Tags: FDA, Idec BLA, hemophilia B
CSL Behring has received FDA orphan drug designation for its recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The designation was granted for the treatment and prophylaxis of bleeding episodes in ...
Tags: CSL Behring, rIX-FP, hemophilia B
Inspiration Biopharmaceuticals has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the approval of IB1001, used for the treatment and prevention of bleeding in individuals with hemophilia B. ...
Tags: FDA, IB1001, intravenous recombinant factor IX protein
Baxter International has collaborated with Chatham Therapeutics for the development and commercialization of factor IX hemophilia B gene therapy treatment. According to the agreement, the companies will investigate the next generation of ...
Tags: IX hemophilia B gene therapy, Biological Nano Particles, clinical trials