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.
AstraZeneca Plc will sell commercial rights for two products to a German pharmaceutical company for $400 million as the British drugmaker looks to focus on newer medicines in new therapy areas.
The European medicines watchdog recommended approving AstraZeneca’s treatments for a form of heart failure and a lung disorder, the British drugmaker said.
Cytokinetics’ stocks plummeted after the company released topline results from a Phase III cardiovascular clinical trial with partners Amgen and Servier in which the secondary endpoint to prove potential to save lives failed.
Boehringer Ingelheim and Eli Lilly announced that the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, met the primary endpoint.