A year after its $175 million IPO in 2024, Arrivent Biopharma Inc. picked up rights to develop and commercialize Lepu Biopharma Co. Ltd.’s antibody-drug conjugate (ADC) candidate, MRG-007, worldwide excluding the greater China region.

Medexus Pharmaceuticals Inc. looks set for its U.S. launch of bifunctional alkylating agent treosulfan in the first half of 2025 following a long-awaited FDA approval of the drug, branded Grafapex, for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults and pediatric patients, 1 and older, with acute myeloid leukemia or myelodysplastic syndrome.

With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs.

Masimo Corp. selected Catherine (Katie) Szyman, an industry leader with deep med-tech roots, to guide the company as it seeks to rebuild its reputation and revenues following a gritty two-year battle for control. Current CEO Michelle Brennan will serve as chairman of the Masimo board. Brennan stepped up to lead Masimo after founder and former CEO Joe Kiani resigned following a shareholder vote that ousted him from his position of board chair as part of a protracted proxy battle between Kiani and Politan Capital Management LP.

Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments waiver, will enable clinicians to detect several STIs including chlamydia, gonorrhea and Mycoplasma genitalium, in as little as 20 minutes.

Standing for live visualization of brain circuits, LVIS Corp launched the cloud-based Neuromatch Access platform as a software as a service to help neurologists and medical professionals review, interpret and analyze electroencephalogram (EEG) data.

Ravgen Inc. prevailed in a hearing at the Federal Circuit over Labcorp Inc., seemingly bringing a close to a long-running dispute over patents for non-invasive prenatal tests. Ravgen has won damages that will likely exceed $400 million over alleged infringement of its patents for these tests, proof once again that a solid understanding of prior art is essential to avoid costly litigation.

It’s one thing for the scientific community to propose a fundamental change to the way obesity is defined and diagnosed. But it’s another for that proposal to be adopted by regulators, especially when the current definition that relies primarily on the body mass index is entrenched in guidance and obesity drug development and approval.