An already-intrigued Wall Street appreciated Relay Therapeutics Inc.’s Jan. 10 update during the J.P. Morgan Healthcare Conference (JPM), where the company detailed progress across its development efforts, including those with RLY-4008, an oral small-molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), in the works for patients with FGFR2-altered cholangiocarcinoma (CCA) and other cancers. Shares of the Cambridge, Mass.-based firm (NASDAQ:RLAY) ran up by about 38%, or $6, in the five days ahead of Jan. 13. The stock closed Jan. 17 at $20.45, down 32 cents.
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.
A study in a mouse model of tau protein build-up in the brain, similar to that seen in later stage Alzheimer’s disease (AD), shows that changes to the microbiome in these animals can impact the degree and progression of neurodegeneration observed. As reported in the Jan. 12, 2023, study published in Science, the researchers found that mice that were germ free and those given antibiotics to change their gut microbiome early in life had significant reductions in brain atrophy compared with those with a standard microbiome.
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.
Sotera Health Services LLC, the parent company of Sterigenics US LLC, has agreed to pay $408 million to settle more than 870 lawsuits pending against the company in Illinois as a means of moving past the specter of ongoing litigation over Sterigenics’ use of ethylene oxide (EtO) for contract medical device sterilization. The settlement may open the doors to litigation over other sterilization plants’ use of the sterilant, constituting an industry-wide attack on device sterilization services that may crimp supplies of devices that are not candidates for other methods of sterilization.
Proposed mergers with Chinese companies will likely be subject to increased scrutiny from the Committee on Foreign Investment in the United States (CFIUS) as evidenced by the temporary hold placed on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd. that was announced in June 2022.
Cardiovascular Systems Inc. (CSI) reported the submission by its partner Innova Vascular Inc. of U.S. FDA premarket notification for thrombectomy devices to treat peripheral vascular disease. Already an acknowledge leader in atherectomy technologies, St. Paul, Minn.-based CSI intends to acquire and commercialize each device to expand its technology portfolio to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
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