Device makers know all too well the hazards of liability where their products are concerned, but those liabilities may soon balloon dramatically in the EU. Two pieces of EU legislation are in development, including the AI Liability Directive, which may have the effect of forcing the defendant in a liability case to prove that its product was not the cause of the alleged harm.
Repair Biotechnologies Inc. has received encouraging feedback from a pre-IND meeting with the FDA as it works toward an IND filing to conduct a phase Ib study of its REP-0003 mRNA therapy in patients with homozygous familial hypercholesterolemia (HoFH).
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.
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
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.
China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
The EMA has started a review of Novo Nordisk A/S’ GLP-1 receptor agonist, semaglutide, after the Danish regulatory agency raised the possibility it causes an increased risk of suffering from an acute eye condition. After the first report in July 2024, the Danish regulator had received, by Dec. 10, 2024, a total of 19 reports of non-arteric anterior ischemic neuropathy, a rare condition that affects the small blood vessels at the front of the optic nerve. This can lead on to sudden vision loss and visual field defects.
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