China’s National Medical Products Administration has approved Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), through priority review for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received at least one trastuzumab-containing regimen.
Dermasensor Inc. received CE mark approval for its handheld skin cancer detection device using spectroscopy and AI to test suspicious skin lesions for cancer in real time at the point of care. The device is designed to help qualified healthcare professionals decide whether suspicious skin lesions need further investigation. With skin cancer rates rising, the Dermasensor joins several other AI-based tools entering the European market to help with the analysis of suspicious lesions.
Tolerability is a key factor in the appeal of Enliven Therapeutics Inc.’s ELVN-001 for previously treated chronic myeloid leukemia (CML), which yielded positive updated phase I data from the Enable trial. Dennis Kim, hematologist from Princess Margaret Cancer Center in Toronto, said he would use the drug for a patient “who doesn’t have any other options.”
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Atavistik, Chiesi, Disc, Gen1e, Matisse, Personalis, Redhill, Vertanical, Xenix, Zai Lab.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Aditxt, Alembic, Artera, Cartesian, Exeltis, Ignite Proteomics, Novanta, Photocure, Riverpoint, Smart Eye, Standard Biotools, Treeline, Westgene.
Clinical updates for biopharma and med tech, including data readouts and publications: Alpha, Astrazeneca, Bial, DBV, Gilead, JCR, Merck, Neurocrine, Spruce, Teleflex, TG, Zetagen.
Biopharma and med-tech companies raising money in public or private financings, including: Aim Immunotech, Antogen, Cerus, City, Corvus, Dicot, Eloxx, Ideaya, Idorsia, Shattuck, Starton.
Former principal officers of the American Diabetes Association (ADA) have hit back at the association’s board and CEO after it prohibited the distribution of an editorial published in its flagship journal Diabetes Care at the ADA’s meeting in New Orleans last Friday.