BeiGene a global oncology Chemotherapy company that plans to rebrand itself as BeOne Medicines Ltd., has achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) approval of TEVIMBRA® (tislelizumab-jsgr). This approval pertains to its use in combination…
Argenx SE a global immunology company dedicated to improving the lives of people affected by severe autoimmune diseases, has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved VYVDURA for the treatment of adults with chronic inflammatory…
Bristol Myers Squibb has announced positive results from arthritis two pivotal Phase 3 trials, POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), which evaluated the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). Both trials met…
In a significant victory for patient safety, the judge presiding over Eli Lilly’s case before the International Trade Commission (ITC) ruled that U.S. Customs and Border Protection should block the illegal importation of counterfeit tirzepatide products. This decision was grounded…
Regeneron Pharmaceuticals has announced positive Phase 2 results for two innovative monoclonal antibodies targeting distinct domains of Factor XI. REGN7508, designed to maximize anticoagulant activity while minimizing bleeding risk, targets the catalytic domain, while REGN9933, aimed at patients with the…
Roche has announced results from the Phase IIb PADOVA study investigating prasinezumab in 586 individuals with early-stage Parkinson’s disease. Participants received treatment for a minimum of 18 months while maintaining stable symptomatic therapies. The study’s primary endpoint, time to confirmed…
Viatris announced the publication of Phase 2b CARE study results evaluating the efficacy and safety of cenerimod in adults with moderate-to-severe systemic lupus erythematosus (SLE). The findings, published in Lancet Rheumatology, demonstrated that cenerimod 4 mg provided clinically meaningful and…
Teva Pharmaceuticals and Sanofi today announced that the Phase 2b RELIEVE UCCD study of duvakitug (TEV’574/SAR447189), an anti-TL1A monoclonal antibody, met its primary endpoints for the treatment of moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). The study, which evaluated…
Bayer announced positive topline results from the global Phase III QUASAR study, which evaluated the efficacy and safety of aflibercept 8 mg in patients with macular edema following retinal vein occlusion (RVO), including central, branch, and hemiretinal vein occlusion. The…
Regeneron Pharmaceuticals, Inc announced today that the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) Injection 8 mg has successfully met its primary endpoint. The trial evaluated the treatment of macular edema following retinal vein occlusion (RVO), including central, branch,…
Sanofi and Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd., have announced promising results from the RELIEVE UCCD phase 2b study, which met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD). The study…
GSK plc has announced that ViiV Healthcare, the global HIV-focused company majority owned by GSK with Pfizer and Shionogi as shareholders, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency…