China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.
The force is with Field Medical Inc. as it celebrates the U.S. FDA’s decisions to grant breakthrough device designation (BDD) to its Fieldforce ablation system and to accept it into the agency’s Total Product Life Cycle Advisory Program pilot. Field Medical designed the Fieldforce pulsed field ablation catheter specifically to treat ventricular tachycardia. The BDD applies to its use in monomorphic scar-related VT.
Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement.
Data from a preclinical study assessing Mission Therapeutics Ltd.’s clinical-stage USP30 inhibitor MTX-652, for the prevention of transverse aortic constriction (TAC)-induced cardiac hypertrophy and remodeling, were recently presented.
Ferroptosis is a programmed cell death mechanism driven specifically by lipid peroxidation. Previous research found that ferroptosis is linked to the onset and progression of cardiovascular diseases, particularly those closely associated with vascular endothelial cell (VEC) injury.
Recent findings have unveiled that 15-HETE is the endogenous agonist for G protein-coupled receptor 39 (GPR39) in vascular smooth cells, so researchers hypothesized that GPR39 could work as a therapeutic target in pulmonary arterial hypertension and its deletion might prevent the development of the disease.
Potent siRNAs against B4GALT1 were designed in silico and screened in vitro (Huh7 cells, primary mouse, human hepatocytes) as well as in vivo (C57BL/6 mice) for the selection of a lead Galomic siRNA.
Meril Life Sciences Pvt Ltd. recently launched its next generation transcatheter heart valve (THV), the Myval Octapro THV, which it says allows for better operator control for precise positioning and improved predictability in implantation. The new valve comes however, as the company battles with Edwards Lifesciences Corp. in a European court over patent infringement of its technology.
Investigators from Duke University hypothesized that hirudin-like protease inhibitors could be generated by linking exosite-binding aptamers with small-molecule active site inhibitors, thus generating more potent “EXACT” inhibitors.
Although there is a clear clinical need for transcatheter mitral valve replacement technologies, a number of challenges must be overcome before they can safely be used to treat patients with mitral regurgitation. Nevertheless, two new devices could enter the European market next year, Edwards Lifesciences Corp.’s Sapien M3 and Highlife Medical SAS’s Highlife TMVR device.