Medicines Articles
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.
Prophylactic treatment with an anti-inhibitor coagulant complex (FEIBA NF [Factor Eight Inhibitor Bypassing Activity], Baxter Healthcare) reduced the median annualized bleeding rate (ABR) more than three-fold as compared with on-demand treatment with the product to control acute hemorrhages, according to a Phase III study of 36 subjects with hemophilia A or B and inhibitory alloantibodies to factor VIII or factor IX.
A recent study conducted in Japan showed significant early post-administration improvements in sepsis patients who were given a single-dose administration of intravenous immune globulin (IVIG).
DiaVacs’ type 1 diabetes therapy DV-0100 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA).
A new study has found that patients who skip an antibiotic often used by hospitals to combat infection during patients’ stays and prescribed to continue that fight after discharge are more likely to return to the hospital.
Low-dose intravenous immune globulin added to a course of corticosteroids has been found to be superior to corticosteroid therapy alone in resolving toxic epidermal necrolysis and reducing associated mortality risk.
The U.S. Food and DrugAdministration has approved obinutuzumab (Gazyva, Genentech)for the treatment of patients with previously untreated chronic lymphocyticleukemia.
The Centers for Disease Control and Prevention has updated its recommendations for the use of VariZIG.
The U.S. Food and Drug Administration has approved a 10 g (50mL) vial size for Hizentra, immune globulin subcutaneous (human).
