The US Food and Drug Administration (FDA) has granted “breakthrough therapy designation” to an investigational, combination therapy of daclatasvir and asunaprevir for genotype 1b chronic hepatitis C (HCV) developed by Bristol-Myers Squibb.
Gilead Sciences filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for ledipasvir (LDV)/sofosbuvir (SOF), a fixed-dose combination therapy for genotype 1 hepatitis C infection (HCV).
Novo Nordisk announced the completion of a phase 3 clinical trial of N8-GP (turoctocog alfa pegol), a third-generation, long acting recombinant factor VIII (rFVIII) product intended for prevention and treatment of bleeding in people with hemophilia A.
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.
Novo Nordisk has received a recommendation for marketing approval from a committee of the European Medicines Agency (EMA) for its hemophilia treatment turoctocog alfa, a third-generation recombinant factor VIII (rFVIII) product intended for prevention and treatment of bleeding in people with hemophilia A.
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.