Bayer’s finerenone has hit key targets in a late-stage trial assessing its safety and efficacy in patients with chronic kidney disease (CKD) and type 2 diabetes.
Data from the Phase III FIDELIO-DKD renal outcomes study show that the drug significantly reduced the combined primary endpoint of chronic kidney disease progression, kidney failure or kidney death versus placebo when added to standard of care.
Finerenone also lowered the risk of a composite of time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospitalisation, thereby by also meeting secondary targets.
Finerenone is the first investigational non-steroidal, selective mineralocorticoid receptor antagonist to show renal and cardiovascular benefits in patients with chronic kidney disease and type 2 diabetes, according to the firm.
Bayer said it will discuss the data with health authorities with a view to submitting a marketing application in this setting.
By: Selina McKee
Source: Pharma Times
A monkeypox outbreak is emerging in the U.S. and Europe, and at least one country is amping up countermeasure preparedness. Bavarian Nordic has secured a contract with an unnamed European country to supply its smallpox vaccine, called Imvanex in Europe, in response to the emergence of monkeypox cases, the Danish company said Thursday.
Moderna’s recent chief financial officer debacle—in which Jorge Gomez departed on his second day on the job—raised questions about the company’s hiring process given its rush to global biopharma prominence. The most obvious one: How was it possible for Gomez to be hired when he was under investigation by his previous employer, Dentsply Sirona of Charlotte, N.C.
Merck & Co. is plucking a cancer project from the branch of Chinese-based Kelun Pharmaceutical for up to $1.4 billion, but details from the New Jersey-based Big Pharma have been hard to come by. The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing over $47 million in upfront cash in exchange for ex-China rights to a “macromolecular tumor project.”