CSPC Pharmaceutical Group Ltd. has gained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2062 injection, a double-stranded small interfering RNA (siRNA) drug to treat hypertension.
The first acellular tissue engineered vessel for adults with vascular trauma in a bodily extremity has been approved by the U.S. FDA. Symvess, which comes from regenerative tissue developer Humacyte Inc., can be used to repair an arterial injury that could be life threatening and require immediate attention.
Ionis Pharmaceuticals Inc. CEO Brett Monia predicted that diagnoses of familial chylomicronemia syndrome (FCS) will “accelerate fairly quickly” now that the firm has gained U.S. FDA clearance for Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with the rare form of severe hypertriglyceridemia (sHTG) that can lead to life-threatening acute pancreatitis (AP).
Dexcom Inc. put real money behind expanding its integration efforts, with a $75 million investment in the $200 million series D for Ōura Health Oy, the maker of the Ōura smart ring. Ōura and Dexcom also provided details on a strategic partnership that integrates data from Dexcom’s continuous glucose monitors with vital sign, sleep, stress, heart health and activity data from the Ōura ring.
Merck & Co. Inc. has turned to Asia for a second time to get into the GLP-1 market, this time to Shanghai-based Hansoh Pharmaceutical Group Co. Ltd. for its investigational preclinical oral small-molecule GLP-1 receptor agonist. Hansoh is getting $112 million up front and could bring in another $1.9 billion in milestone payments. Merck said the addition to its GLP-1 arsenal is “to provide additional cardiometabolic benefits beyond weight reduction.”
Chia Tai Tianqing Pharmaceutical Group Co. Ltd. has synthesized sodium-bile acid cotransporter (SLC10A1; NTCP) inhibitors reported to be useful for the treatment of cardiovascular, fatty acid oxidation, liver and gastrointestinal disorders.
Merck & Co. Inc. and Hansoh Pharmaceutical Group Co. Ltd. have entered into an exclusive global license agreement for HS-10535, a preclinical oral small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist. Hansoh Pharma has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535.
Wall Street must wait until 2025 for data from the higher-dose cohort in Tenaya Therapeutics Inc.’s phase Ib/II study with gene therapy TN-201 for MYBPC3-linked hypertrophic cardiomyopathy (HCM), but shares (NASDAQ:TNYA) closed Dec. 17 at $1.41, down $1.47, or 51%, after results from the first cohort rolled out.
A gene therapy based on an enhanced lipid nanoparticle (LNP) loaded with vascular endothelial growth factor (VEGF) mRNA could be developed for the treatment of preeclampsia, according to a study in mice in which it alleviated maternal hypertension until the end of gestation and improved fetal health. Preeclampsia is a disease that affects 3% to 5% of pregnant women, who suffer from hypertension and proteinuria, elevated levels of protein in the urine, during pregnancy.
Heartbeam Inc. received U.S. FDA 510(K) clearance for its portable, non-invasive electrocardiogram system that enables on-the-go recording of heart signals. The cable-free, credit card-sized device uses five electrodes to capture signals from three directions and can be used whenever a patient feels symptoms, overcoming the challenge of identifying intermittent arrhythmias, which are often not experienced during scheduled appointments, without requiring patients to wear a device continuously.