Putting in writing what it’s been saying at advisory committee meetings, the U.S. FDA is issuing a draft guidance on multiregional clinical trials for cancer drugs that underscores the need for applicability to the U.S. population and medical practices.
Genentech’s newly approved multiple sclerosis (MS) injection takes about 10 minutes to administer, dramatically reducing the four to six hours required by its intravenous predecessor. The U.S. FDA approved the humanized monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for relapsing MS and primary progressive MS on Sept. 13.
Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.).
The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.
Exact Sciences Corp. reported performance data for its blood-based colorectal cancer screening test that showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.
Hiiti Sillo, director of the WHO’s office for regulation and safety, told an audience at this year’s IMDRF meeting in Seattle that WHO is putting the finishing touches on a streamlined product application dossier process, one of several work products that should be ready for publication sometime in 2025.
Cullinan Therapeutics Inc. has submitted an IND application to the FDA to evaluate its CD19 x CD3 bispecific T-cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE).
Intercept Pharmaceuticals Inc. lost its uphill battle to convince the U.S. FDA’s Gastrointestinal Drugs Advisory Committee that the risks of its second-line primary biliary cholangitis drug outweigh the benefits. The committee overwhelmingly said the data in the follow-up studies of treating the rare disease with Ocaliva (obeticholic acid), which has accelerated approval from the FDA, was insufficient.
The U.S. Department of Justice reported that THD America Inc., and its Italian corporate parent company agreed to pay $700,000 over inducing physicians to use incorrect payment codes in Medicare and Medicaid claims.
The U.S. FDA approved Apple Inc.’s Airpods Pro 2 as an over-the-counter assistive hearing device for adults with mild-to-moderate hearing loss, making the ubiquitous devices the first assistive hearing technology to receive this designation.
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