Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor inhibitor, pimicotinib, met both primary and secondary endpoints in the phase III Maneuver global study evaluating pimicotinib for treatment of tenosynovial giant cell tumor.

Autolus Therapuetics plc has been granted FDA approval for Aucatzyl (obecabtagene autoleucel) for the treatment of acute lymphoblastic leukemia in adults, becoming the first marketed CAR T therapy that does not have a risk evaluation and mitigation strategy attached to its label. The approval of Aucatzyl was based on results of the Felix clinical trial in relapsing/remitting ALL, which showed a strong safety profile compared to existing CAR T-cell therapies. The conduct of the trial was dogged by the COVID-19 pandemic, but of the 65 patients from an initial dosed cohort of 95 for whom efficacy was evaluated by the FDA, 63% achieved overall complete remission.

Alteogen Inc. scored another deal for its human recombinant enzyme, ALT-B4, on Nov. 8, reeling in Daiichi Sankyo Co. Ltd. in a potential $300 million deal including $20 million up front and up to $280 million in milestone payments, along with royalties based on net sales.

Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange.

University of Auckland senior research fellow Jeff Smaill first visited China in 2012 as part of a team of 15 scientists from the Maurice Wilkins Center, one of New Zealand’s centers of excellence, to meet with scientists at the Guangzhou Institute of Medicine and Health to find partners to collaborate on drug development projects. The scientists started collaborating that year, and the first project is already in phase I trials in China. It was a joint discovery and development partnership from the beginning, he said.

In a pipeline shakeup, Tango Therapeutics Inc. has halted enrollment in a phase I/II study in order to push two other brain cancer drugs into development. TNG-908 had success in treating non-CNS solid tumors such as non-small-cell lung cancer and pancreatic cancer but missed the minimum pharmacokinetic exposure in clinical efficacy for treating glioblastoma.

Celltrion Inc. posted preclinical study results of two new antibody-drug conjugate (ADC) candidates – CT-P70 and CT-P71 – at the World ADC 2024 conference in San Diego Nov. 6, with plans to move the assets into clinical trials. Poster presentations of both ADC candidates “drew significant attention from the attendees” at the oncology meeting, Incheon, South Korea-based Celltrion said, while highlighting its efforts to transition from a biosimilar maker to a novel therapy developer.

While the size of the market is enormous, drug development and treatments for women’s health care still lag behind what is offered for men. There has been a renaissance in the past few years, however, led by investors and companies that have wrestled with determining exactly what encompasses women’s health and how to meet its challenges.