China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA. Read More
Experts in mRNA convened at the Global Vaccine Forum (GVF) 2025 to weigh the present and future of vaccine technology, including emerging innovations in self-amplifying mRNA (sa-mRNA) and drug delivery platforms. “Breakthroughs in mRNA and next-generation vaccine platforms are revolutionizing how we prepare for and respond to global health challenges,” Jerome H. Kim, International Vaccine Institute (IVI) director general, told the audience in Seoul, South Korea, June 19. Read More
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance. Read More
BioWorld tracked 223 clinical trial updates across phases I to III in May 2025, marking an increase from 197 in March and 151 in April. Among these, 17 trials reported positive phase III results, while two ended in failure and another two delivered mixed outcomes. Read More
An experimental drug for treating diabetes and obesity has been shown to lower blood sugar levels and increase fat burning. It is a β2-adrenergic receptor (β2AR) agonist that mimics the effects of physical exercise by activating skeletal muscle metabolism. Unlike GLP-1-based treatments such as semaglutide and tirzepatide, this new compound, developed by researchers at the Karolinska Institute, Stockholm University, and the biotech company Atrogi AB, does not suppress appetite or cause muscle loss. Read More
The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alebund, Altimmune, Alto, Crispr, Edgewise, Gri, I-Mab, Invivyd, Lisata, Metabolics, Opus, Pfizer, Viatris. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: CDR-Life, CSL, Hummingbird, Kalvista, Northern Antibiotics, Novartis, Pendopharm, Percheron, Profound, Prokaryotics, Valneva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Biocity, Carsgen, Emmaus, Pint, Theravance, Viatris. Read More
