ADMA Biologics’ IVIG Product (RI-002) Receives Positive Phase III Results

ADMA Biologics has received positive results on the primary and secondary endpoint evaluations from the Phase III trial for its intravenous immune globulin (IVIG) product RI-002 to treat primary immunodeficiency disease(PI).

Higher Dosages of 25% Albumin Associated with Lower Incidence of Cerebral Ischemia and Infarction in Pilot ALISAH Study

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).

4-Factor Prothrombin Complex Concentrate Superior to 3-Factor Version for Reversal of Coumarin Anticoagulation in Rat Model

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.

rFVIII Treatment for Hemophilia A Receives Positive Results

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.

CSL Enrolls First Patient in Study of rVIII-SingleChain

CSL Behring has enrolled its first patient in the pivotal pediatric PhaseIII study to evaluate the efficacy, safety and pharmacokinetics of its novel investigational recombinant factor VIII single chain (rVIII-SingleChain) for the treatment of previously treated children (up to 11 years) with severe hemophilia A.

Phase III Trial for Long-Acting Factor VIII Shows Positive Results

Positive results have been shown with the completion of pathfinder2 for hemophilia A patients 12 years and older.

Quadrivalent VLP Vaccine Achieves Phase II Trial Endpoints

Novovax Inc.’s quadrivalent seasonal influenza virus-like particle (VLP) vaccine demonstrated the company’s PhaseII clinical trial’s primary endpoint of safety and immunogenicity of three ascending dose levels.

Grifols Launches New IVIG Alzheimer’s Trial

Grifols has launched a new study into methods of treatment for Alzheimer’s disease.

Subcutaneous Immunoglobulin Is a Potential Alternative to Intravenous Immunoglobulin in CIDP

Danish investigators conducted a trial of adult patients to test whether subcutaneous immunoglobulin therapy is a viable alternative to intravenous immunoglobulin therapy in chronic inflammatory demyelinating polyradiculoneuropathy.

Albumin Infusion Cuts Renal Impairment and Mortality Risk in Patients with Spontaneous Bacterial Peritonitis

U.S. and Italian investigators performed a meta-analysis of randomized controlled trials to quantify the effect of albumin administration on renal impairment and mortality in patients with spontaneous bacterial peritonitis.