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.
New data from a sub-analysis of the landmark Phase III DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) trial showed that AstraZeneca’s Farxiga (dapagliflozin) reduced the incidence of the primary composite endpoint of heart failure worsening or cardiovascular death compared to placebo, in patients with heart failure with reduced ejection fraction, irrespective of their background therapy.
Invokana won U.S. approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
Clinical data for a fish-oil-based drug from Amarin Corporation confirmed the drug’s ability to reduce the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death.
Continuing its efforts to address high prescription drug costs, insurer Highmark entered into a new outcomes-based contract with Boehringer Ingelheim for Jardiance (empagliflozin), an oral medicine indicated to lower blood sugar in adults with type 2 diabetes, and also to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
Boehringer Ingelheim and Eli Lilly announced an academic collaboration with the University of Oxford to investigate the effects of Jardiance on the progression of kidney disease and the occurrence of cardiovascular death, in adults with established chronic kidney disease with and without diabetes.
A large study of a new type of cholesterol medicine from Merck & Co. Inc. found it cut the risk of heart attack and death by a modest 9 percent, while causing a build up of the drug in fat tissue, leaving its commercial future uncertain.
The FDA approved an expanded use of Novo Nordisk’s diabetes drug Victoza to reduce the risk of cardiovascular events such as heart attack and stroke.
AstraZeneca’s blood-thinner Brilinta cuts the risk of cardiovascular death by 29 percent in patients with a history of past heart attacks who keep taking it beyond the standard 12-month initial period, according to new clinical trial data.
The biotech industry did OK in July 2017. The NYSE ARCA Biotech Index and the iShares NASDAQ Biotechnology Index (ETF) grew about 1.9 percent and 2.9 percent, respectively last month. There have been 26 new molecular entity approvals so far this year. With that figure in mind, here are eight companies looking at PDUFA dates in August 2017.