Factor XIa inhibitors milvexian and asundexian, hailed as the next-generation class of anticoagulants, earned mixed reviews on phase II data presented during the European Society of Cardiology Congress 2022. However, developers Bristol Myers Squibb Co./Janssen Pharmaceutical Co. and Bayer AG, respectively, are moving into late-stage testing, citing clear mechanisms of action that put the FXIa drugs at least on par with approved factor Xa drugs in terms of efficacy while offering potentially better safety profiles that could give physicians an option for patients with stroke or atrial fibrillation who are currently undertreated with anticoagulants due to bleeding risks. Read More
Sirnaomics Ltd. went five for five in its study of treating cutaneous basal cell carcinoma. Five of five patients in a cohort of the open-label, dose-escalation phase II study of STP-705, composed of two sIRNA oligonucleotides targeting transforming growth factor beta 1 and cyclooxygenase-2, had a 100% complete response. Read More
If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC, it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that’s still an if. Whether the patent infringement case involving a so-called “skinny label” makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts. Read More
Gate Neurosciences Inc. was first founded in 2019, but officially launched last week with two clinical-stage assets and a bold goal: to develop better drugs for CNS disorders and identify better-suited patients for those drugs. The company’s first molecular target is the NMDA receptor. Gate has acquired the rights to two NMDA receptor modulators, zelquistinel and apimostinel. Read More
Scientists have discovered a new antibiotic called evybactin that is able to selectively target Mycobacterium tuberculosis, the bacteria that causes tuberculosis (TB) lung infections. As described in NatureChemicalBiology on Aug. 22, 2022. the work is still at an early stage and requires further validation. But, if successful in clinical trials, evybactin could form part of a new group of specific antibiotics designed to target TB. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Alvotech, Amarin, Fibrogen, Timber. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Inhibikase, Novavax, Pfizer. Read More
