The Food and Drug Administration on Aug. 23 approved Cara Therapeutics’ drug to treat moderate-to-severe itching in patients with chronic kidney disease undergoing dialysis, making Korsuva the first therapy for the ailment in the United States.
After receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for the New Drug Application for tenapanor for control of serum phosphorus in adults with chronic kidney disease on dialysis, Waltham, Mass.-based Ardelyx is restructuring to save money.
Shares of Cara Therapeutics were up in trading after the company struck a licensing agreement worth up to $290 million with Switzerland’s Vifor Pharma for the commercialization of a treatment for severe itching associated with chronic kidney disease.
Akebia Therapeutics’ investigational drug vadadustat hit the mark in the first of two Phase III trials in chronic kidney disease (CKD) patients who are on dialysis. In premarket trading, shares of Akebia were up more than 21 percent to $10.55.
Ardelyx Inc.’s experimental medicine tenapanor showed promise in a late-stage study as a standalone therapy to reduce elevated blood phosphate levels in patients with chronic kidney disease (CKD).
Ardelyx’s Phase III AMPLIFY study of tenapanor achieved the clinical trial’s primary endpoint, as well as all key secondary endpoints, in treating patients with chronic kidney disease (CKD).
Teva Pharmaceutical Industries Ltd. said the drugmaker will pay an undisclosed amount to settle an ongoing dispute with Amgen Inc. over the company’s generic cinacalcet hydrochloride (HCl) product.
Schultz Chan, the former director of biostatistics at Cambridge-based Akebia Therapeutics, and Songjiang Wang, a director of statistical programming at Merrimack Pharmaceuticals, were convicted of insider trading by a federal grand jury in Boston.
A federal jury in Colorado awarded $383.5 million to the families of three patients who said they suffered cardiac arrests and died soon after receiving dialysis treatments at clinics run by DaVita Inc.
Shares of pain-relief company Cara Therapeutics were up more than 16 percent after the company grabbed the Breakthrough Therapy Designation for its chronic kidney disease treatment CR845.