Kyorin Pharmaceutical Co. Ltd. is licensing Hinge Bio Inc.’s multispecific antibody-based therapy HB-2198 in Japan for multiple autoimmune indications, starting with systemic lupus erythematosus.

Like the federal district court before it, the U.S. Court of Appeals for the Third Circuit said it lacks jurisdiction to rule on the merits of Novo Nordisk A/S’ claim that the CMS violated the Inflation Reduction Act (IRA) when it treated six of the company’s insulin aspart products as one negotiation-eligible single-source drug.

Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.

Lexeo Therapeutics Inc. feels like it’s in a faster lane to a BLA for its Friedreich ataxia cardiomyopathy gene therapy after talking with the U.S. FDA. The agency told Lexeo that LX-2006 could be on the accelerated approval path if there is a mingling of the company’s data and studies.

The brain-computer interface (BCI) system being developed by Precision Neuroscience Corp. is capable of capturing high-resolution brain signals and stimulating areas without damaging the cortical surface, according to a study published in Nature Biomedical Engineering.

Icecure Medical Ltd. reported that the U.S. FDA has granted marketing authorization to Icecure's de novo application for the Prosense cryoablation system for the local treatment of breast cancer in patients 70 years of age or older with biologically low-risk tumors. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.

While the final word has yet to be written, Stryker Corp. came out the biggest winner in a dispute involving four related patents owned by Osteomed LLC, part of Colson Associates’ Acumed.

Even though the U.S. CDC is operating on a skeleton crew due to the partial government shutdown, it is updating its immunization schedules to adopt the COVID-19 and chickenpox vaccine recommendations the Advisory Committee on Immunization Practices (ACIP) made at its September meeting.

A top-line readout of the 26-week phase IIa Cbeyond trial showed nimacimab, Skye Bioscience Inc.’s peripherally restricted CB1 inhibitor antibody for weight loss, fell short of statistical significance as a monotherapy vs. placebo on the primary endpoint of weight loss, sending the company’s shares down 60%. Skye executives, however, offered a more optimistic outlook for the findings, which they said provide clear direction for moving forward.

In a deal that could bring more than $2.1 billion in payments to Arbor Biotechnologies Inc., 90-year-old Chiesi Group gained exclusive and global rights to develop and commercialize ABO-101 for primary hyperoxaluria type 1, an ultra-rare disease caused by a mutation in the AGXT gene, as well as an option to go after a limited number of additional targets.