Novo Nordisk A/S' Ozempic, a once-weekly injectable version of the company's glucagon-like peptide-1 (GLP-1) receptor agonist, semaglutide, first FDA-approved in late 2017, has won the agency' approval for a new indication: reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes (T2D) and known heart disease.
With a label broadened by the FDA in December and two aspiring competitors apparently picked off via late-stage trial blowups, Amarin Corp. plc finds itself in strong position with fish oil therapy Vascepa (icosapent ethyl) – at least pending the outcome of court proceedings that involve challengers to patents for the cardiovascular (CV) drug.
DUBLIN – Compared to other indication areas, gene therapy for cardiac disease is still at the “caveman” stage, according to Dinaqor AG CEO and Chairman Johannes Holzmeister. The Pfäffikon, Switzerland-based firm aims to drag it into the modern era by applying a novel locoregional delivery system to its adeno-associated virus 9 (AAV9) vector technology.
Little more than a month after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously supported approval of Amarin Corp. plc's fish oil-based Vascepa (icosapent ethyl) for reducing the risk of cardiovascular (CV) events in adults with elevated triglyceride levels, the agency has greenlighted a label expansion for the already-approved medicine, allowing for its adjunctive use in that indication.
Vancouver, British Columbia-based Correvio Pharma Corp. is hoping that it will receive a positive response from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, which meets tomorrow to consider the U.S. approvability of Brinavess (vernakalant hydrochloride, I.V.), its antiarrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation (AF).
BEIJING – Tokyo-based biotech firm Heartseed Inc., which focuses on regenerative medicine, has closed a series B financing round to pocket $26 million that will go to its lead drug candidate, HS-001, for treating heart failure.
DUBLIN – 4Teen4 Pharmaceuticals GmbH raised €6.9 million (US$7.7 million) in a series A round to take procizumab, a first-in-class inhibitor of circulating dipeptidyl-peptidase 3 (cDPP3), into clinical trials for patients with cardiogenic shock.
Stem cell biotech firm Novoheart Holdings Inc., of Vancouver, British Columbia, is partnering with Astrazeneca plc, of Cambridge, U.K., to co-develop a human-specific in vitro, functional model of heart failure with preserved ejection fraction.
A study published in the Nov. 27, 2019, advance online issue of Nature manages a rare feat. It is both a vindication of and egg in the face for cardiac stem cell research. The good news is that cardiac stem cell transplantation after a heart attack does improve heart function, although the effect is “mild,” Jeffery Molkentin told BioWorld.
Positive phase III data from the Advocate trial by Chemocentryx Inc. and Vifor Fresenius Medical Care Renal Pharma caused Chemocentryx’s stock (NASDAQ:CCXI) to dramatically rise 281% on Tuesday, clearing the way to an NDA filing for the star small-molecule attraction, avacopan, an oral, selective complement 5a receptor inhibitor.
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