With a new drug available to slow the progression of type 1 diabetes, Sanofi SA is partnering with two med-tech companies to increase screening for early-stage type 1 diabetes and identify eligible patients.
Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.
While the discussions and votes at the past two meetings of the U.S. CDC Advisory Committee for Immunization Practices (ACIP) have generated a lot of controversy and resulted in some states and medical groups issuing their own vaccine schedules, the truth is that the newly reconstituted committee’s recommendations to date are still in line with, or more generous in some instances than, global norms.
Pharma companies are collaborating to boost the power of artificial intelligence (AI) in drug discovery by allowing access to proprietary structural data to train a large language model. Each of the partners is contributing data from several thousand experimentally determined protein:ligand interactions, creating one of the most diverse datasets and the richest chemistry assembled to date for model training.
Boston Scientific Corp. continues to prove out its strategy of active acquisitions combined with industry-leading organic growth with the closing of its $88 million acquisition of Elutia Inc.’s Bioenvelope business and very positive targets for growth presented during its investor day on Sept. 30.
Convatec Group plc plans to invest more than $1 billion in the U.S. and U.K. over the next decade as it looks to accelerate its research and development (R&D) ambitions.
AI seems to suggest that a world of problems with health care spending may become more manageable, but Stephen Bittinger, a shareholder in the D.C. office of the law firm of Polsinelli PC told BioWorld that all the headaches surrounding validation of these algorithms suggests a need for an independent AI validation institute.
The market for colorectal cancer screening tests seems poised to heat up considerably with a recent request for Medicare coverage for Genoscopy’s Colosense test, but some who commented on the proposal have misgivings about the lower level of specificity seen in the Colosense relative to the Cologuard.
Caught between the start of fiscal 2026 and a congressional funding standoff that shut down much of the U.S. federal government Oct. 1, the FDA will not be able to collect 2026 user fees until Congress agrees on a continuing resolution or a 2026 appropriations bill.
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.