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.
Three biopharmas debuted on Nasdaq Sept. 13, raising a combined $703 million for two Massachusetts-based companies focused on bifunctional antibodies for autoimmune diseases and cancer, and one Midwestern firm developing peptide therapies for endocrine and metabolic disorders.
Immuneering Corp. CEO Benjamin Zeskind said he is “pleased with enrollment across the full trial” that’s ongoing with IMM-1-104 in cancer, and 30 subjects are due per arm in five arms that the phase IIa experiment includes.
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.
Despite heightened political tensions, both Chinese and U.S. industry officials are working to strengthen ties in the health care and biotech sector, including launching strategic initiatives to foster Sino-U.S. biotech investment and M&A deals. As one of the initiatives, representatives from Hong Kong, China and the U.S. convened at the Bio Hong Kong 2024 conference to launch a global health care M&A and financial investment alliance, along with fostering company and talent growth in Hong Kong.
As Novo Nordisk A/S and Eli Lilly and Co. go head-to-head in the U.S. and Chinese glucagon-like peptide-1 receptor agonists (GLP-1RA) market for diabetes and obesity, Novo Nordisk is in innovator gear once more with leading studies of GLP-1s in Alzheimer’s disease.
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 first patenting from Encephalogix Inc. details its development of platform that uses machine learning and AI to analyze EEG data that is typically ignored.
Moderna Inc.’s shares (NASDAQ:MRNA) sank 19% to a $64.11 low in early trading Sept. 12 as investors learned during the annual R&D Day event of a $1.1 billion reduction to R&D and the U.S. FDA’s reluctance to support an accelerated approval filing for its individualized neoantigen therapy for melanoma.
The U.S. FDA issued warning letters to a pair of non-clinical testing labs located in China for violations of good laboratory practices, but the fall-out may reach existing marketing authorizations.
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