Belharra Therapeutics Inc., an early stage firm which is pioneering a new approach to chemoproteomics, has already found an influential backer for the distinctive way it systematically probes the interactions between small-molecule ligands and the proteins to which they bind. Read More
Eli Lilly and Co., through its wholly owned subsidiary Prevail Therapeutics Inc., is delving more deeply into gene therapies. In a new collaboration, Prevail will use privately held Capsida Biotherapeutics Inc.’s adeno-associated virus engineering platform, coupling the tech with Prevail’s gene therapies to target causes of CNS diseases. Read More
After Vera Therapeutics Inc.’s disappointing 24-week data from the Origin phase IIb study with atacicept in immunoglobulin A nephropathy (IgAN), Wall Street is looking forward to more results at 36 weeks, due later this year. Read More
Geron Corp. executives highlighted a potential billion-dollar market opportunity for imetelstat on the back of positive phase III data for the telomerase inhibitor in patients with lower-risk myelodysplastic syndromes (MDS), news that sent shares (NASDAQ:GERN) rising 36% and could portend the first regulatory win for a scientific approach the company has pursued since the 1990s. Read More
Phathom Pharmaceuticals Inc.’s shares sank 31% on news that the U.S. FDA will not take action on the company’s NDA for oral small-molecule potassium-competitive acid blocker vonoprazan by the Jan. 11 PDUFA date. Read More
After more than five years and extensive feedback, the U.S. FDA is finalizing its guidance on the format and content of risk evaluation and mitigation strategy (REMS) plans for prescription drugs and biologics associated with serious risks. Read More
After receiving approval in Japan for its orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622) in late November, Shionogi & Co. Ltd. is gearing up for approvals in South Korea and China. Read More
Hadasit Medical Research Services and Development Ltd. and BIRAD – Research & Development Company Ltd. have inked a development deal with Immix Biopharma Inc. for tissue specific therapeutics based on their jointly developed anti-B-cell maturation antigen CAR T cells targeting plasma cell technology. Read More
China’s NMPA has approved Merck & Co. Inc.’s COVID-19 treatment molnupiravir for emergency use to combat the increasing number of cases in the country. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alligator, Anthos, Chemomab, Hutchmed, Jasper, JS, Kiora, Newron, Nrx, Redhill, Regenerx, Sensorion, Theralase, Tiziana, Valneva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Athenex, Evaxion, Gilead, Hotspot, Janssen, Legen, Orasis, Profoundbio. Read More
