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 where Multitude retains all rights. According to terms of the deal, Shanghai-based Multitude will receive an undisclosed up-front payment and development, regulatory, and commercial milestone payments worth more than $1 billion, as well as tiered sales-based royalties.

CRL lands on Regeneron for multiple myeloma prospect linvoseltamab

Few likely were surprised by Regeneron Pharmaceuticals Inc.’s complete response letter (CRL) from the U.S. FDA regarding the application for 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. In the course of the BLA review, regulators informed Regeneron that the third-party fill/finish manufacturer for linvoseltamab had unresolved findings from a preapproval inspection for another company's product candidate. Those findings have been resolved, but a reinspection will be required. Shares of Tarrytown, N.Y.-based Regeneron (NASDAQ:REGN) were trading at $1,195.31, up $3.08.

US FDA approves J&J’s Rybrevant-Lazcluze combo for lung cancer

The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor (TKI) called Lazcluze (lazertinib) as a first-line combination treatment for select non-small-cell lung cancers (NSCLC). The combination therapy was cleared Aug. 19 to treat adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. Lung cancer is a leading cause of mortality worldwide. TKI therapy is the standard of care for EGFR mutation-activated NSCLC, with Astrazeneca plc’s third-generation EGFR TKI, Tagrisso (osimertinib), being the current standard of care.

FTC noncompete ban struck down by district court

The U.S. Federal Trade Commission’s (FTC) 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. The judgment is final and can be appealed. The judge had been expected to rule by Aug. 30 or if the U.S. Court of Appeals for the Fifth Circuit had entered the case. Doing away with noncompetes could be particularly harmful in the biopharma and med-tech industries where they have been used to protect patents and trade secrets, according to some legal experts.

US lawmakers flag clinical trials with ties to China military

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 more scrutiny. In a letter to FDA Commissioner Robert Califf, the bipartisan leadership of the House Select Committee on China said the agency needs to “play a greater role in analyzing” U.S. companies’ clinical trial operations in China. While the Aug. 19 letter specifically addresses biopharma issues, the concerns raised also could apply to medical devices being tested in China.

Female sex hormones, adiposity are bad mix in multiple sclerosis

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 has gained new insights into possible causes for this increasing disparity. The findings, which were published online in Cell Metabolism on Aug. 20, 2024, provide an explanation for why obesity during adolescence increases the later risk of developing multiple sclerosis, and why it does so more strongly in women.

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