AstraZeneca’s proposed treatment for heart disease delivered positive high-level results from the company’s Phase III DELIVER trial.
When you have a brand with as much promise as Farxiga, you need someone at the helm with the drive and vision to help it reach its full potential. And that person is senior director of marketing for Farxiga, Allison Garrity. When Garrity joined the Farxiga team, the established AstraZeneca brand already had a strong legacy in type 2 diabetes (T2D), but momentum had stalled, teams needed to be rebuilt, and – the biggest challenge of all – Farxiga had to revolutionize care again, this time with indications in heart failure (HF) and chronic kidney disease (CKD).
The U.S. FDA rejected Cambridge, Massachusetts-based Akebia Therapeutics’ New Drug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
The U.S. Food and Drug Administration rejected Reata Pharmaceuticals’ New Drug Application for the company’s proposed chronic kidney disease drug, citing a lack of proof of effectiveness.
Legend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.
Ardelyx reported in a regulatory filing that the U.S. Food and Drug Administration sent an Appeal Denied Letter (ADL) for the company’s drug tenapanor, a therapeutic intended for chronic kidney disease.
Reata Pharmaceuticals Inc. announced the outcome of the U.S. Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting on bardoxolone methyl for the treatment of patients with chronic kidney disease caused by Alport syndrome.
GlaxoSmithKline is lining up a potential new treatment for patients with anemia due to chronic kidney disease following positive results in a Phase III study that showed the investigational candidate daprodustat improved or maintained hemoglobin levels without an increase in cardiovascular risk.
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.
