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.

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.

DUBLIN – Novartis AG is making a $9.7 billion bet that the economics of an siRNA-based drug can better those of monoclonal antibodies and thus provide it with a dominant position in a major but still emerging cardiovascular drug market. The Basel, Switzerland-based pharma made an $85 per share offer for The Medicines Co., which has taken inclisiran, an siRNA-based inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the brink of an approval in reducing the risk of a cardiovascular event – heart attack or stroke – in high-risk patients with cardiovascular disease or high levels of low-density lipoprotein cholesterol (LDL-C) who are inadequately controlled on current therapies.

CAR T cells engineered to target fibroblast activating protein (FAP) could reverse cardiac fibrosis and restore cardiac function in mice, researchers have reported in the Sept. 12, 2019, issue of Nature.

The failure of Novartis AG's Entresto in a phase III clinical trial staggered the stock (NASDAQ:NVS) somewhat Monday, down just 1.14%, but the real trauma may well be the loss of roughly $2.5 billion in anticipated sales.