Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced July 29 the company’s BiovitalsHF solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug Administration.
Sarfez Pharmaceuticals announced approval by the U.S. Food and Drug Administration of the Virginia-based company’s New Drug Application for Soaanz, a once-a-day improved formulation of the loop diuretic torsemide.
The U.S. Food and Drug Administration greenlit AstraZeneca’s Farxiga (dapagliflozin) under priority review for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes.
Clarivate published the company’s annual “Drugs to Watch” list, and cited several medicines that the analysts expect to be blockbusters – projected to bring in $1 billion in sales annually.
Novartis’ Entresto is the first therapy approved in the United States to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF).
The U.S. Food and Drug Administration approved Merck & Co. and Bayer AG’s heart failure drug Verquvo (vericiguat), an orally administered soluble guanylate cyclase stimulator.
After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up, according to BioSpace.
Novartis’ bid to pump up sales of Entresto beyond $5 billion annually got a boost when a U.S. Food and Drug advisory panel recommended the heart failure medicine be used to treat a different form of the disease.
AstraZeneca is selling European rights (excluding Spain and the UK) to the erstwhile blockbuster cholesterol drug Crestor to German pharmaceutical company Grünenthal as the British drugmaker focuses on cancer treatments.
Cytokinetics Inc. said a pivotal trial of the experimental heart failure drug the company is developing with Amgen Inc. showed a slightly higher rate of cardiovascular-related death for patients given the medicine compared to those on a placebo.