HONG KONG — Akeso, Inc. (9926.HK) is excited to announce that its globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has received approval from the National Medical Products Administration (NMPA) for its supplementary New Drug Application (sNDA) for use as a monotherapy for the first-line treatment of PD-L1-positive (TPS ≥ 1%) non-small...
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Paris, France – Ivosidenib is under clinical development by Les Laboratoires Servier and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. Ivosidenib overview Ivosidenib (Tibsovo / AG-120) acts as...
IXICO plc (AIM: IXI), the AI data analytics company delivering insights in neuroscience, announces that it has been awarded a contract by a new US biopharmaceutical client to support its Phase II Huntington’s disease (HD) clinical trial. HD is a rare condition of the nervous system that impacts the way...
Redmond, WA and Princeton, NJ – SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, and Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC)...
New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open-label extension phase Up to 128 weeks and 180 patient years of follow-up in the open-label extensiona confirm a safety profile consistent with the Phase 3...
First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies gMG...
Somerset, NJ – Legend Biotech announced in an SEC filing on Tuesday that the FDA will convene its Oncologic Drugs Advisory Committee to discuss the use of its Johnson & Johnson-partnered Carvykti (ciltacabtagene autoleucel) in earlier lines of treatment for multiple myeloma. The panel of external experts will evaluate J&J...
Phase 2b SunRISe-1 study shows more than 82 percent of patients achieved complete response (CR) with more than half of responders remaining cancer-free at one year after CR Results reinforce potential of TAR-200 to transform outcomes for certain types of BCG-unresponsive, high-risk non-muscle invasive bladder cancer LAS VEGAS, Nevada...
São Paulo, Brazil – In a study with 49 participants, researchers at the State University of Campinas found that daily consumption of a dietary supplement containing 15 g of the substance for five weeks improved glucose metabolism even after meals. The skin or peel of the Jaboticaba berry (Plinia jaboticaba),...
BEIJING, SHANGHAI and BOSTON, Mass. — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor glecirasib and novel SHP2 inhibitor JAB-3312. JAB-3312 is the first SHP2 inhibitor...