Genfleet Therapeutics (Shanghai) Inc. has patented receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitors reported to be useful for the treatment of stroke, rheumatoid arthritis, psoriasis, heart failure, nonalcoholic steatohepatitis and inflammatory bowel disease.
New research published in BMJ Open claims there are inconsistencies in Amgen Inc.’s phase III Fourier study for cholesterol lowering. Cardiac deaths were numerically higher in those taking the PCSK9 inhibitor Repatha (evolocumab) combined with a statin than those in the placebo group, the research noted.
Zylox-Tonbridge Medical Technology Co. Ltd. has obtained marketing approval for its retrievable inferior vena cava (IVC) filter Zylox Octoplus in China. “Zylox Octoplus is approved for the prevention of pulmonary embolism (PE) and deep vein thrombosis (DVT) in the peripheral vasculature,” a spokesperson at Zylox-Tonbridge told BioWorld. The approval is based on a multi-center, randomized and positive control clinical trial in China. The trial was conducted in nine peripheral vascular intervention centers in China.
Carmat SA just completed a flash fundraising of $33 million to increase production of its Aeson total artificial heart and support sales growth in Europe. The operation featured two distinct but concurrent actions: a reserved offer and a public offer. The reserved offer, intended for specialist investors, raised $28.9 million.
Researchers in Japan may have found a way to repair cardiac damage in patients suffering from chronic heart attack and heart failure by reprogramming cardiac fibroblasts (CFs) to cardiomyocytes (CMs) in a mouse model of chronic myocardial infarction (MI). Published online Dec. 12, 2022, in Circulation, the study showed that by tweaking the expression of a few key genes, researchers could reverse the lasting damage caused by heart attacks.
A new acute coronary syndrome detection system developed by Neuome Peptides Pte. Ltd.’s aims to make tests for the frequently lethal condition faster, more precise and less invasive. Neuome’s Truheart is a point-of-care assay for cardiovascular disease that is used in the company’s established Instadetect assay development platform. The assay measures the biomarkers troponins I and T and myoglobin.
The U.S. False Claims Act (FCA) provides one of the more potent legal weapons in the federal government’s enforcement arsenal and three companies felt the sting of the FCA in the closing weeks of December 2022. Advanced Bionics LLC fell under the sway of the FCA related to allegations that it misused a performance standard in its premarket filing for cochlear implants, while Biotelemetry Inc. and its Cardionet LLC subsidiary will fork over more than $44 million for improper claims filed with the Medicare program.
Damage to the left ventricle may be more common than damage to its cousin on the other side, but right heart failure is still a unique syndrome with its own specific needs. Chuck Simonton, the chief medical officer at Abiomed Inc., told BioWorld that both the company and the U.S. FDA are keen to remind cardiologists that early detection and treatment of right heart failure vastly improves outcomes, including a huge reduction in mortality in these desperately ill patients.
The move away from in-clinic testing continues, with another company offering a convenient, at-home sensor that gathers critical health information without requiring any change on the part of the patient, which may provide even more accurate, real-world data on patient health than the tests they replace.
As the Feb. 28, 2023 PDUFA date for the compound nears, Cytokinetics Inc. CEO Robert Blum insisted that his firm is not mulling withdrawal of the marketing application for heart failure drug omecamtiv mecarbil, nor is the company now considering another study, after an unfavorable vote on the drug Dec. 13 by the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee.
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