Evolve Biologics (“Evolve”), a division of Therapure Biopharma Inc. (“Therapure”) and an innovative developer of plasma-derived therapeutics, today announced that it has dosed the first pediatric patient in its Phase III multicenter clinical trial of PlasmaCap™ IG (Intravenous Immunoglobulin or “IVIG”), in addition to having administered half of the infusions required for the adult portion of the study, which completed enrollment in February 2018. The study received approval to proceed from the U.S. Food and Drug Administration (“FDA”) and Health Canada last summer.
Grifols (MCE: GRF, MCE: GRF.P, and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and provider of a variety of postexposure prophylaxis and immune globulin products for patients, has received approval from the U.S. Food & Drug Administration (FDA) for a new higher potency formulation of its HyperRAB® rabies immune globulin [human] for rabies postexposure prophylaxis (treatment of a person immediately after exposure to the rabies virus). The new formulation is twice the potency (300 IU/mL) of currently available rabies immune globulin options, offering a greater concentration of anti-rabies virus antibodies within each mL of volume, and for patients, the potential for fewer injections by significantly reducing the volume of medication administered in each dose.