The trophoblast cell surface antigen 2 (TROP2) class chalked mix news by way of Astrazeneca plc and Daiichi Sankyo Co. Ltd. as the pair disclosed phase III data from the closely watched Tropion-Lung 1 trial with datopotamab deruxtecan (dato-dxd) against non-small-cell lung cancer. Read More
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act. Read More
Nanjing Iaso Biotherapeutics Co. Ltd. and Innovent Biologics Inc. said on July 2 they gained China NMPA approval for the first self-developed and in-house manufactured CAR T therapy Fucaso (equecabtagene autoleucel) to treat relapsed or refractory multiple myeloma. Read More
The U.S. Federal Trade Commission (FTC) has proposed to expand the volume and type of information it will require of companies seeking to merge with competitors, a move the agency said is predicated in part on concerns about the influence of non-U.S. entities in American markets. Whatever one thinks of the justifications, this proposal would not only dramatically expand the volume of data required of those who propose to merge with other companies, but also add a large volume of work to agency staff at a time when the FTC is complaining that it lacks the resources to do its job. Read More
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments. Read More
Artificial intelligence (AI) continues to entice. On the exhibition floor at the 2023 Congress of the European Academy of Neurology, one company’s booth featured “Mindart” technology. A passersby could answer a short series of prompts, and get a unique image based on the input made by generative AI. Entertainment aside, medically speaking, AI applications “are still research,” Riccardo Soffietti told his audience at one of several sessions devoted to AI. “But obviously, research is the future.” Read More
Both the value and number of reported biopharma nonprofit deals has fallen significantly, being at the lowest amount in the past five years. Compared to the first five months of last year, the value of biopharma nonprofit deals has decreased by about 63%. Meanwhile, money raised via grants has fallen slightly, 6.11%, but is vastly less than the value and number seen in 2020. Read More
Sinotau Pharmaceutical Group raised ¥1.1 billion (US$152 million) in a financing round to develop its radiopharmaceutical drugs for diagnostic and therapeutic interventions. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Capricor, Cyclo, Enterome, Genfit, Ipsen, Kyverna, Neuren, Pharmaessentia, PTC, Sanofi Pasteur, SK. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Alvotech, Amgen, Boehringer Ingelheim, Celltrion, Coherus, Fresenius, Organon, Samsung Bioepis, Sandoz, Shionogi, Tonix, Zymedi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Argenx, Biomarin, Drug Farm, Madrigal, Merus, Scisparc, Unicycive, Zai Lab. Read More
