Adcendo ApS has inked a deal with Multitude Therapeutics Inc. and is licensing Multitude’s phase I-ready antibody-drug conjugate (ADC), ADCE-T02, which targets tissue factor. Under the deal, Copenhagen, Denmark-based Adcendo gains exclusive development and commercialization rights for the ADC globally, excluding greater China (mainland China, Hong Kong, Macao and Taiwan) where Multitude retains all rights. Read More
Regeneron Pharmaceuticals Inc. suffered an unsurprising hitch in the form of a complete response letter (CRL) related to linvoseltamab, a bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells containing CD3-expressing T cells, for relapsed/refractory multiple myeloma.
The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor called Lazcluze (lazertinib) as a first-line combination treatment to treat select non-small-cell lung cancers. Read More
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses has been struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as had been planned on Sept. 4. Read More
Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny. Read More
The risk of developing multiple sclerosis (MS) is nearly four times as high for women as it is for men. And that relative risk has increased sharply over time. In 1955, women were only slightly more likely than men to develop MS. A research team at the University of Toronto and the Oklahoma Medical Research Foundation (OMRF) has gained new insights into possible causes for this increasing disparity. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bergenbio, Cumulus, Eli Lilly, Kelun-Biotech, KE Sdn, IGC Pharma, Leadxpro, Merck, Novo Nordisk, Organon, Tempus AI, Titan. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astellas, Astrazeneca, Genmab, GSK, Johnson & Johnson, Kelun, Octapharma, Opus Genetics. Read More
