Hansa Biopharma A/S has turned in positive data from a pivotal U.S. phase III trial of imlifidase, an enzyme that speedily removes antibodies from the bloodstream, enabling highly sensitized kidney patients to have transplants. Read More
Nailing down what Oppenheimer analyst Jay Olson characterized as “a trifecta,” Immuneering Corp. unveiled positive updated survival and safety data from the ongoing phase IIa trial testing oral, once-daily MEK inhibitor atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxe in first-line pancreatic cancer patients. Read More
Jiangsu Hengrui Pharmaceuticals Co. Ltd. struck another $1 billion-plus deal, this time for a HER2-targeting antibody-drug conjugate (ADC), trastuzumab rezetecan (SHR-A1811), with Glenmark Pharmaceuticals Ltd.’s subsidiary Glenmark Specialty SA. Read More
The struggle to avoid a partial U.S. government shutdown at midnight Sept. 30 is getting a lot of attention, as the stakes increase every day of the political standoff. Meanwhile, Sept. 30 also could be the end of the 43-year-old Small Business Innovation Research (SBIR) program, which has been a funding boon for biotech and med-tech startups, if Congress can’t come together on a reauthorization bill. Read More
The winding regulatory road for the BLA to Capricor Therapeutics Inc.’s cell therapy for Duchenne muscular dystrophy has more clarity. Out of a recent type A meeting between Capricor and the U.S. FDA, prompted by a complete response letter in July regarding lead asset CAP-1002 (deramiocel), the two are in agreement about a path to potential approval. Read More
Clarivate plc has unveiled the 2025 Citation Laureates. Widely considered a predictor of the Nobel Prizes, this recognition has highlighted the discovery of biomolecular condensates in chemistry and the innate immunity signaling pathway in physiology or medicine, as well as the identification of leukemia stem cells and ghrelin, the so-called hunger hormone. Read More
About five months after the U.S. FDA disclosed its roadmap to move away from animal testing in favor of new approaches for biopharma drug development, the U.S. National Institutes of Health (NIH) said it is awarding $87 million in contracts over three years to launch the Standardized Organoid Modeling Center. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: Cyclerion, Denali Capital Acquisition, Eli Lilly, Healx, Ironwood, Kancera, Kayothera, Kinea Bio, Medic Life, Novakand, Palvella, Remedium, Semnur, Seres, Solid Biosciences, Theralase, Tisento, Vuja de Sciences. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Artios, Astrazeneca, Bioartic, Biogen, Cure Rare Disease, Daiichi Sankyo. Read More
