The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).
FDA staff reviewers raised concerns over unclear benefits of Ardelyx Inc.’s drug for kidney disease patients, stating, “the magnitude of treatment effect appears less than that observed with approved drugs,” in briefing documents released on Monday.
Boehringer Ingelheim and Eli Lilly said their diabetes drug Jardiance was shown to slow the progression of chronic kidney disease (CKD), as they seek to catch up with market segment leader AstraZeneca.
Shares of Angion Biomedica Corp. are falling fast after the company announced it had discontinued a mid-stage study of an oral tyrone kinase inhibitor in patients with primary proteinuric kidney diseases due to safety reasons. And Novo Nordisk also hit a wall, reporting that its diabetes drug Ozempic (semaglutide) failed to inprove liver fibrosis in NASH-related cirrhosis.
Evotec SE is on a deal-making spree. The company just inked another contract, this time with Janssen Pharmaceutical that showcases Evotec’s end-to-end integrated drug discovery and development platform.
Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to the company’s candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment glomerulosclerosis (FSGS).