The lawsuit claims that CMS’s plan to include the drug, Xphozah, along with all other oral-only phosphate lowering therapies in the End-Stage Renal Disease Prospective Payment System (ESRD) will “significantly and negatively impact patient choice of and timely access to important medications.”
Tag Archive for: kidney disease
The company announced that a Phase III trial of its hypertension and chronic kidney disease candidate failed to hit the primary endpoint, with the Danish drugmaker deciding to discontinue the study and incur an impairment loss of DKK 5.7 billion ($818.9 million) in the second quarter of 2024.
Novartis on Saturday posted two promising Phase III readouts in rare kidney diseases, setting the pharma up for two potential approvals in the space. The company presented these data at the European Renal Association Congress over the weekend.
Novo Nordisk expects to file for regulatory approvals of a label expansion for Ozempic in the US and EU in 2024. The detailed results from FLOW will be presented at a scientific conference in 2024.
Vifor Pharma and partner Travere Therapeutics on Friday won an endorsement for approval from the European Union’s drug regulator for their drug Filspari, part of an industry race to treat a rare, serious kidney condition known as IgAN.
Merck’s experimental drug efinopegdutide, which belongs to the GLP-1 class and is being developed as a treatment for non-alcoholic steatohepatitis (NASH), also showed a “compelling” weight-loss benefit.
DefenCath, a combination of the antimicrobial active ingredient taurolidine and blood thinner heparin, has previously been rejected twice by the U.S. Food and Drug Administration (FDA) on manufacturing concerns.
Following two late-stage failures, Travere Therapeutics has unveiled the results of two Phase III studies, attempting to regain Filspari’s footing in IgA nephropathy and focal segmental glomerulosclerosis.
Treatment with the drug candidate, acquired as part of the purchase of U.S. biotech firm Chinook for up to $3.5 billion, resulted in a meaningful improvement in proteinuria in patients suffering from IgA nephropathy when compared to placebo, the Swiss drugmaker said in a statement.
Today the company announced it will discontinue a trial studying its experimental therapy to treat a type of kidney disease after it failed to meet the main goal of the late-stage study.