Cambridge, Massachusetts-based Akebia Therapeutics announced topline results for PRO2TECT, the second of two Phase III cardiovascular outcomes programs evaluating the company’s vadadustat for treatment of anemia caused by chronic kidney disease in adults not on dialysis.
AstraZeneca’s Farxiga improved survival chances for patients suffering from kidney disease, underscoring the medicine’s role outside the drug’s established field of diabetes.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for Tricida’s experimental chronic kidney disease treatment veverimer.
The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
Novo Nordisk is expanding the company’s presence in treating kidney disease with the acquisition of U.S.-based Corvidia Therapeutics for $2.1 billion.
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.
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) announced positive topline data from the KALM-2 Phase III trial.
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).
The U.S. Food and Drug Administration accepted for review Tricida Inc.’s New Drug Application for veverimer (TRC101) – a non-absorbed, orally administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease – under the Accelerated Approval Program.
AstraZeneca and FibroGen Inc. presented pooled efficacy and cardiovascular (CV) safety analyses from the pivotal Phase III program assessing roxadustat for the treatment of patients with anemia from chronic kidney disease (CKD).