Medicines Articles
CSL Behring’s Biologics License Application for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin, rIX-FP, has been accepted for review by the U.S.
Octapharma USA has launched the Octapharma Co-Pay Assistance Program available to von Willebrand’s disease patients who are currently receiving Wilate or have a prescription to begin therapy.
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) has awarded approximately $12 million to BioCryst Pharmaceuticals for the advanced development of a promising experimental drug for Ebola.
Novo Nordisk has launched Novoeight (antihemophilic factor [recombinant]) in the U.S. for people living with hemophilia A.
A new experimental drug could boost the immune system in older adults by as much as 20 percent, as well as help them to delay other aging effects.
Octapharma USA has launched the Octapharma Co-Pay AssistanceProgram available to von Willebrand’s disease patients who are currently receiving Wilate (von Willebrand factor/coagulation factor VIII complex[human]) or have a prescription to begin therapy.
The U.S. Food and Drug Administration(FDA) has approved Octapharma’s manufacturing facility in Vienna, Austria, for the production of Octagam 10% (immune globulin intravenous [human] 10% [100mg/mL] liquid preparation).
In June, the U.S. Supreme Court voted 5-4 to allow a key exemption to the Affordable Care Act’s contraception coverage requirements, meaning closely held, for-profit businesses can assert a religious objection.
Interim Phase II/III and III findings of a study conducted by CSLBehring demonstrate an improved pharmacokinetic profile of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) among hemophiliaB patients in all age groups.
Baxter’s Phase III clinical trial of BAX855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE (Antihemophilic Factor[Recombinant]), has met its primary endpoint in reducing annualized bleeding rates (ABR) in the prophylaxis arm compared with the on-demand arm.
FDA has approved Iroko Pharmaceuticals’ Tivorbex (indomethacin), a low-dose painkiller for adult patients.
The U.S. Food and Drug Administration has approved HYQVIA (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase), Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency.