After a long and bumpy path to approval, the U.S. FDA has finally given the green light to Cyclopharm Ltd’s Technegas combination product a day after the Sept. 29 PDUFA date.
Evotec SE and Novo Nordisk A/S have announced the launch of Lab En2, a translational drug discovery accelerator that aims to advance early research from academic institutions into novel therapeutics.
Novo Nordisk A/S and Valo Health Inc. have entered into an agreement to discover and develop novel treatments for cardiometabolic diseases. The collaboration will leverage Valo’s Opal Computational Platform, including access to real-world patient data, artificial intelligence (AI)-enabled small-molecule discovery and Biowire human tissue modeling platform designed to speed up the discovery and development process.
A hot biopharma research approach and an equally hot therapeutic area came together in the potential $2.7 billion deal that pairs artificial intelligence (AI) company Valo Health Inc. with Novo Nordisk A/S, which will strive to advance new treatments for cardiometabolic diseases.
At its Investor Day on September 20, Boston Scientific Corp. unveiled an ambitious long-range plan to become “the highest performing med-tech large-cap company” in terms of financial performance, sales growth, EPS, execution and talent retention.” That’s a notable step up from its 2021 goal of being just one of the top performers.
The annual volume of implant of transcatheter aortic valve replacement (TAVR) devices has grown steadily over the years, and that volume might sustain its upward trajectory over the next few years if the results of a new analysis of more than 46,000 TAVR patients gain traction. The data for these patients with minimally symptomatic aortic stenosis (AS) predictably indicated that this group was less susceptible to bad outcomes than those with more severe symptoms, but one of the hopes is that earlier intervention into AS could ward off future cardiovascular events, a finding which might justify expanded payer coverage for TAVR in these patient populations.
Magnet Biomedicine Inc. emerged from stealth mode and pulled down a $50 million series A round co-led by founding investor Newpath Partners alongside Arch Venture Partners. The firm is advancing molecular glue discovery by way of rational selection and design, looking past known protein-protein interactions and what Magnet calls “tangential” degradation approaches to analyze the broader protein landscape and ultimately pair targets with rationally chosen presenters in the tissue where the disease manifests.
Anthos Therapeutics Inc.’s phase II study of abelacimab in treating atrial fibrillation in patients at moderate to high risk of stroke has met its primary endpoint. The data monitoring committee stopped the study early as the fully human monoclonal antibody targeting factor XI/XIa reduced bleeding when compared to a leading standard of care, direct oral anticoagulant, Xarelto (rivaroxaban, Johnson & Johnson).
A U.S. FDA advisory committee’s backing keeps Alnylam Pharmaceuticals Inc.’s Onpattro (patisiran) on the road to a supplemental approval in treating a rare heart disease, but it couldn’t stop the company stock from sliding. Shares (NASDAQ:ALNY) closed Sept. 14 down 8.8% at $193.06, the day after the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 that patisiran’s benefits outweigh the risks in treating cardiomyopathy of transthyretin-mediated amyloidosis.
Calcineurin inhibitors used in clinics – including immunosuppressants for transplant rejection and autoimmune disease treatment – may cause persistent hypertension. Calcineurin inhibitors elevate sympathetic vasomotor activity by decreasing calcineurin activity and potentiating N-methyl-D-aspartate receptor (NMDAR) activity in the hypothalamus. However, how these inhibitors promote NMDAR activity in the hypothalamic paraventricular nucleus to increase sympathetic vasomotor activity remains unknown.
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