Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astrazeneca, Harbour, Novo Nordisk, Revive.
Act Genomics (Hong Kong) Ltd. won U.S. FDA approval for its genomic profiling test for solid tumors, Actonco. This marks the first time an Asia-based company has received FDA clearance for a comprehensive genomic profiling test.
At a time when Chat GPT is making waves in the world of artificial intelligence (AI), new legislation is making the rounds in Washington that would allow an AI algorithm to write prescriptions for pharmaceuticals. Rep. David Schweikert (R-Ariz.) introduced H.R. 206 to the House Energy and Commerce (E&C) Committee Jan. 9, although at present the bill enjoys the backing of no other members of the House, suggesting that this legislation has a steep climb in front of it.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biontech, Genentech, Pfizer.
The U.S. FDA and Health Canada announced that they will roll out a pilot program that allows a medical device manufacturer to submit a medical device application to both agencies simultaneously for class II and class III medical devices.
The U.S. FDA’s 510(k) program is yet again under assault, this time from the authors of a Jan. 10 article in the Journal of the American Medical Association (JAMA). The authors’ primary point seems to be that any 510(k) devices that recite a predicate that is the subject of at least three recalls are themselves more likely than average to be the subject of a recall, although there was no discernible association between recall status and technological differences between the predicate and the follow-on devices.
Although the U.S. Inflation Reduction Act charges the Centers for Medicare & Medicaid Services with negotiating prices of the Part B and D drugs with the highest Medicare spend, the first two rounds of negotiations will focus solely on Part D drugs, which are dispensed through pharmacies.
RSS
