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.
Shionogi & Co. Ltd. won a $375 million project agreement from the Rapid Response Partnership Vehicle to develop its 3CL protease inhibitor, S-892216, as a long-acting injectable for COVID-19 pre-exposure prophylaxis. The project was awarded to New Jersey-based Shionogi Inc., a subsidiary of the Osaka, Japan-based pharmaceutical company. S-892216 is an investigational second-generation 3CL protease inhibitor in development as a long-acting injectable for prophylaxis treatment of SARS-CoV-2.
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
A 6.5-month-old boy with the rare inherited urea cycle disorder ornithine transcarbamylase (OTC) deficiency has responded positively in a targeted in vivo gene editing trial, in which a correct copy of a defective gene was inserted at a precise locus in the genome.
Marking the second global approval after Japan, the U.S. FDA has approved Datroway (datopotamab deruxtecan), a trophoblast cell surface antigen 2-directed antibody-drug conjugate (ADC) from Daiichi Sankyo Co. Ltd. and Astrazeneca plc, for treating adults with hormone receptor-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy.
While Moderna Inc. plans to cut its expenses by $1 billion in 2025, the company has received a little breathing room by a hefty U.S. Department of Health and Human Services (HHS) grant. The Biomedical Advanced Research and Development Authority awarded Moderna roughly $590 million to support late-stage development of its mRNA-based avian-variant vaccines and to increase the number of clinical trials for another five additional subtypes of pre-pandemic influenza.
A series of disappointments that drove Sage Therapeutics Inc.’s stock down by 85% since August of 2023 has evolved into an unsolicited takeout offer by partner Biogen Inc., followed by a lawsuit filed by Sage a week later. The two parties, both of Cambridge, Mass., first partnered in a $1.52 billion deal in 2020, primarily to develop Zurzuvae (zuranolone) for depression. The deal included Biogen taking a 10.2% equity stake in Sage, paying $104.14 per share, or $650 million total.
Just a few weeks later than expected, Inflammatix Inc. secured U.S. FDA clearance of the Triverity test system for use in emergency triage of patients with suspected acute infection or sepsis. The molecular blood test is the first to identify bacterial and viral infections and provide an all-cause risk evaluation of the likelihood of developing severe illness.
The European Union has implemented legislation governing artificial intelligence (AI) with more on tap, but the U.S. has to date lagged in that area. However, the House of Representatives has assembled a bipartisan task force for AI, one of several developments suggesting that 2025 will be an even more AI-focused year than 2024.
Regulatory approval for medical products can rely on real-world data (RWD) typically only for expanded indications for use, but payers have been missing in action where this data source is concerned. The U.S. CMS has floated a guidance to facilitate the use of RWD in coverage decisions, providing a long-overdue update to Medicare clinical trial policy.
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