On the verge of top-line data from its phase IIb trial with oral small-molecule CC chemokine receptor 4 (CCR4) antagonist zelnecirnon in atopic dermatitis (AD), due around the middle of this year, Rapt Therapeutics Inc. said the U.S. FDA has imposed a clinical hold on that study with the otherwise promising drug, also known as RPT-193, in AD as well as the phase IIa trial with the same compound in asthma. Read More
Roughly 35 years after early patient data suggested the potential of tumor-infiltrating lymphocytes (TIL) in cancer, Iovance Biotherapeutics Inc. received U.S. FDA approval for lifileucel, marking both the first autologous TIL cell therapy for commercial use and the first one-time cell therapy for a solid tumor cancer. Branded Amtagvi, lifileucel is cleared for use in patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor Read More
In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China. Read More
The biological processes giving rise to the central nervous system symptoms of long COVID remain a mystery. But multiple studies suggest they do not appear to be a result of a direct viral infection of brain tissue. The latest such research, which appeared online in Nature Neuroscience on Feb. 16, 2024, demonstrated that local immune response in brain tissues persisted long after SARS-CoV-2 virus had disappeared. Read More
Autoantibodies call to mind disease – autoimmune disease, to be exact. But the physiological roles of autoantibodies are, at the very least, more complex than this view accounts for. “The autoantibody reactome is extraordinary,” Aaron Ring told BioWorld. “Nearly everyone has autoantibodies, whether they know it or not.” Read More
Unless there’s a last-minute meeting of the minds, it looks like any extension of the World Trade Organization’s (WTO) five-year intellectual property waiver for COVID-19 vaccines will be shelved, at least for now. Read More
The U.S. FDA has accepted for review Daiichi Sankyo Co. Ltd.’s and Astrazeneca plc’s BLA for datopotamab deruxtecan (dato-dxd) to treat adults with locally advanced or metastatic nonsquamous non-small-cell lung cancer who have received prior systemic therapy. Read More
After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abionyx, Bostongene, CASI, CSL, Denali, Galapagos, Gilead, Inventiva, Sanofi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Almirall, Apotex, Astrazeneca, Biocytogen, Biofrontera, Evaxion, Everest, Gilead, Ginkgo, Gracell, Freeline, Icosavax, Merck & Co., Novo Nordisk, Organon, Orion, Providence, Sosei, Tenax. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AI Therapeutics, Astellas, Incannex, Kurome, Otsuka, Pyros, Sanofi, Sarepta, Visterra. Read More
