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
Mabwell Biopharmaceuticals has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration to initiate a Phase IIa clinical study for its anti-ST2 monoclonal antibody, 9MW1911, in patients with moderate-to-severe chronic obstructive pulmonary disease. This regulatory milestone comes on the heels of a completed Phase IIa study in China, where Mabwell
For decades, China’s biopharma sector was best known for its rapid scaling of biosimilars, generics, and “fast follower” biologics. Industry watchers, both inside and outside the country, regarded Chinese firms as volume leaders but not science front-runners. This is now changing. The first-in-human dosing of IBI3011, Innovent Biologics’ anti-IL-1RAP monoclonal antibody, marks a turning point
STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed
Can four doses replace chronic ITP therapy? Find out how Novartis’ ianalumab performed in the VAYHIT2 trial and what it could mean for autoimmune care.