USP Hosts Symposium on Science and Standards
The US Pharmacopeia Convention (USP) held its first Science and Standards Symposium in Sao Paulo, Brazil on August 23-24. The meeting focused on the importance of the Biopharmaceutics Classification System. Almost 300 regulators, academics, pharmaceutical manufacturers, and quality control experts from Latin American countries and the US attended the Symposium, which was cosponsored by the University of Sao Paulo. According to a press release, Roger Williams, MD, chief executive officer of USP, closed the meeting by asking the attendees to think about a “global system of interchangeable products.” Williams stated, “If you have a highly soluble drug substance that is rapidly dissolving, it should be optimally bioavailable. Then, if you have two different products with the same active ingredients that are both optimally bioavailable, they should be bioequivalent.” According to release, “drug product monographs in the new USP Medicines Compendium, coupled with labeling, might advance the general approach for the classification and regulation of biopharmaceuticals.”
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.