The FDA has delayed NASP without raising clinical approvability concerns, shifting attention to manufacturing controls, contract facilities and Sobi’s resubmission strategy.
Health Canada clears EMPAVELI for C3G and IC-MPGN. Read what this changes for nephrology treatment, market access, and rare kidney disease care.
Swedish Orphan Biovitrum AB (Sobi) has reported positive topline data from the Phase 2a EMBRACE trial of Gamifant (emapalumab) in interferon-gamma-driven sepsis (IDS), demonstrating organ function improvement and a potential survival benefit. Based on the signal, the drug will advance in development in collaboration with the Hellenic Institute for the Study of Sepsis (HISS). The
Swedish Orphan Biovitrum AB has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Aspaveli, the pegcetacoplan-based therapy developed in partnership with Apellis Pharmaceuticals Inc., for the treatment of C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis. The recommendation covers use in patients aged 12 years and older