FDA Approves Baxter’s HYQVIA for Treatment of PI

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.

21st Century Medicine: Now It’s Personal

Thanks to breakthroughs in genome sequencing, personalized medicine is rapidly becoming more science than fiction. As experimental therapies are replaced with data-driven solutions, we may be closer than ever to the kind of patient-specific care that promises to revolutionize the way medicine is practiced.

Prophylaxis with Anti-Inhibitor Coagulant Complex Reduces Bleeding Episodes

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.

Single-Dose IVIG Results in Early Improvements in Sepsis Patients

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).

FDA Grants Orphan Status to Diabetes Reversal Drug

DiaVacs’ type 1 diabetes therapy DV-0100 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA).

Discharged Patients Who Skip Antibiotic Likely to Be Rehospitalized

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.

IVIG in Combination with Corticosteroids Reduces Morbidity and Mortality in Toxic Epidermal Necrolysis

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.

FDA Approves Obinutuzumab for CLL

The U.S. Food and DrugAdministration has approved obinutuzumab (Gazyva, Genentech)for the treatment of patients with previously untreated chronic lymphocyticleukemia.

CDC Updates VariZIG Use Recommendations

The Centers for Disease Control and Prevention has updated its recommendations for the use of VariZIG.

New Vial Size Approved for CSL Behring’s Hizentra

The U.S. Food and Drug Administration has approved a 10 g (50mL) vial size for Hizentra, immune globulin subcutaneous (human).