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).
The “Albumin in Subarachnoid Hemorrhage” (ALISAH) pilot clinical trial, conducted at the Baylor College of Medicine in Houston, assessed the neuroprotective effects of varying dosages of 25% human albumin. Vasospasm, delayed cerebral ischemia (DCI) and cerebral infarction were evaluated in 20 patients who received seven consecutive daily infusions of 0.625 g/kg (Tier 1), 20 who received 1.25 g/kg (Tier 2), and seven who received 1.875 g/kg (Tier 3).
In an established preclinical bleeding model, reversal of coumarin anticoagulation with Kcentra, a four-factor prothrombin complex concentrate (4F-PCC), was shown to be superior to three-factor prothrombin complex concentrates(3F-PCCs), according to findings reported by CSL Behring investigators.
Eight consecutive patients on long-term, hospital-based intravenous immunoglobulin (IVIG) therapy to treat chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (n=4) and multifocal motor neuropathy (MMN) (n=4) were switched to home-based subcutaneous immunoglobulin (SCIG).
At the end of February, the Centers forDisease Control and Prevention (CDC)reported that the 2014-15 seasonal influenza vaccine was just 18 percent effective against the dominant strain of flu.
Title II of the Drug Quality and Security Act (DQSA), known as theDrug Supply Chain Security Act(DSCSA), took effect on January 1, 2015.
Under the Affordable Care Act, the Department of Health and Human Services (HHS) awarded millions in health grants in 2014.
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.
A new Drug Enforcement Administration regulation allows pharmacies,hospitals, clinics and other authorized collectors such as long-term care facilities to serve as authorized drop-off sites for unused prescription drugs.
A proposed rule by the Centers for Medicare and Medicaid Services would add to the list of Medicare-reimbursable telehealth activities, as well as pay for telehealth services in rural areas nearer big cities under a geographical expansion.
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.
