Bristol Myers Squibb Co.’s audacious $13.1 billion 2020 takeover of Myokardia Inc. appears to have paid off with U.S. FDA approval of the drug at the heart of the deal, mavacamten. The medicine, a cardiac myosin inhibitor for treating adults with obstructive hypertrophic cardiomyopathy (HCM), will be marketed under the brand name Camzyos.
Be’er Sheva, Israel-based Dia Imaging Analysis Ltd. has partnered with technology conglomerate Intel Corp. to accelerate the analyzing time of its artificial intelligence (AI)-based cardiac ultrasound software. Dia said Intel’s Open Vino toolkit will optimize the processing time of its Lvivo Seamless solution by over 40%.
Arrowhead Pharmaceuticals Inc. and Vivo Capital LLC have launched a joint venture named Visirna Therapeutics for RNA interference therapeutics in the greater China market. Arrowhead is the majority shareholder of the new entity, while Vivo invested $60 million in the new entity.
Yes, getting FDA 510(k) clearance for your medical device is something to cheer about. But consider Arterys Inc. It just reported its eighth FDA clearance, this time for a next generation, deep learning cardiac analytics platform. The Cardio AI’s purpose, Arterys CEO John Axerio-Cilies told BioWorld, is to leverage artificial intelligence (AI) and deep learning for analysis of cardiac MRI images that is faster, more accurate and repeatable than ultrasound and other imaging modalities.
Venus Medtech (Hangzhou) Inc.’s Venusp-Valve, a transcatheter pulmonic valve replacement (TPVR) system, has gained the CE mark in Europe. The system is used to treat moderate to severe pulmonary regurgitation with or without right ventricular outflow tract stenosis. The TPVR provides an alternative for those not eligible for open-chest operations because of the risks such as large trauma, and slow recovery, a spokesperson of Venus Medtech told BioWorld.
Forcefield Therapeutics Ltd. has arrived on the scene with £5.5 million (US$7 million) in funding to advance development of naturally occurring proteins that have been shown to arrest the loss of cardiomyocytes in the immediate aftermath of myocardial infarction.
The days when paclitaxel was the subject of controversy in connection with peripheral artery disease (PAD) seem to be drawing to a close, thanks in part to a new drug-coated balloon (DCB) by Trireme Medical Inc., of Pleasanton, Calif. Trireme’s Chocolate Touch device, a second-generation DCB with paclitaxel as an antiproliferative, fared well against a legacy paclitaxel device, thus opening a new front in the competition in the PAD space and seemingly relieving any concerns about the safety of paclitaxel.
Windtree Therapeutics Inc.’s positive top-line data from the phase II study called Seismic, testing istaroxime in cardiogenic shock (CS), a form of sudden heart failure (HF), add “a lot of interesting strategies and options” with the compound, also in development for acute HF, said CEO Craig Fraser.