Evogene Ltd. and Eleo Inc. have established a strategic scientific collaboration to discover and develop next-generation oral small-molecule inhibitors targeting the PCSK9 pathway for the treatment of hyperlipidemia and cardiovascular diseases.
Once again, Arrowhead Pharmaceuticals Inc.’s Redemplo (plozasiran) is hot on the heels of Ionis Pharmaceuticals Inc.’s Tryngolza (olezarsen). Less than a month after the latter gained U.S. FDA approval for use in severe hypertriglyceridemia (sHTG), Arrowhead reported positive top-line results from its phase III studies in sHTG, with findings described by one analyst as “best-case scenario,” setting the stage for a supplemental NDA filing with the FDA before year-end.
Shanghai Yogar Therapeutics Co. Ltd. has divulged new apelin (APJ) receptor agonists potentially useful for the treatment of heart failure, pulmonary hypertension and muscle atrophy.
AMT Medical BV reported positive one-year data from a study looking at its ELANAdevice, a sutureless coronary bypass technology designed to simplify one of the most technically demanding steps in coronary artery bypass grafting, and potentially expand use of the minimally invasive procedures.
Branded Lipfendra, Merck & Co. Inc.’s oral PCSK9 inhibitor enlicitide, part of the FDA Commissioner’s National Priority Voucher pilot program, won U.S. approval to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.
Two med-tech companies agreed to settlements with the U.S. government to resolve False Claims Act (FCA) allegations that they submitted Medicare claims for medically unnecessary testing and devices.
Pulmonary arterial hypertension (PAH) is a fatal condition characterized by abnormal vascular remodeling from excessive proliferation of pulmonary arterial smooth muscle cells (PASMCs). Recent evidence has suggested that structural maintenance of chromosomes 4 (SMC4) is upregulated in pulmonary tissue from patients with PAH and may be a potential target for therapy, since it has been tied to modulating pathological cell proliferation.
Atrium Therapeutics Inc. has obtained IND clearance from the FDA for ATR-1072 for the treatment of protein kinase AMP-activated non-catalytic subunit γ2 (PRKAG2) syndrome.
Drug Farm Biotechnology Co. Ltd. closed a $55 million series D round to advance its AI-developed alpha-protein kinase 1 (ALPK1) inhibitor, DF-003, in a phase III trial for ROSAH syndrome, a rare genetic disease that can lead to blindness.
Edwards Lifesciences Corp. and Genesis Medtech Group Ltd. will pay a total of $12 million in penalties as part of a U.S. FTC settlement resolving allegations that they intentionally structured a deal in which Edwards acquired Genesis’ JC Medical to avoid complying with the notification and waiting period requirements of the Hart-Scott-Rodino Act.
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