Last month, Baxter International, Inc., announced the completion of enrollment in its ongoing clinical trial of BAX 855, an investigational extended half-life, recombinant factor VIII (rFVIII) therapy for treatment of patients with hemophilia A.
Phase 3 data from Biogen Idec and Swedish Orphan Biovitrum AB for ELOCTATE™, the companies’ investigational recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A, were published online in the journal Blood. ELOCTATE™ uses a technology called Fc fusion to prolong the time the therapy circulates in the body, which may extend the time between prophylactic infusions.
In September, Boehringer Ingelheim Pharmaceuticals, Inc., announced the completion of patient enrollment for a Phase 2a clinical trial investigating a new interferon-free, all-oral, direct-acting antiviral combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection.
Two companies, Canada-based Sernova Corp. and Germany-based Medicyte announced last month that they have entered into a Material Transfer Agreement (MTA) to jointly evaluate the use of Medicyte’s upcyte® cells in Sernova’s Cell Pouch™ for the treatment of patients with hemophilia A.
Last month, Biogen Idec announced that the US Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for the marketing approval of ELOCTATE™ a recombinant factor VIII (FVIII) Fc fusion protein for the treatment of hemophilia A.
The US Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor manufactured by Raritan, NJ-based Janssen Research & Development. Protease inhibitors work by blocking the enzyme protease, preventing the hepatitis C virus (HCV) from replicating inside host cells.
In May, Bayer AG discontinued a Phase 2/3 trial for BAY 86-6150, its investigational recombinant factor VIIa (rFVIIa) product for the treatment of patients with hemophilia A or hemophilia B and inhibitors.