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Renal Diseases

FDA Accepts Horizon Therapeutics’ NDA to Make its Nephropathic Cystinosis Procysbi Available as Oral Granules in Packets

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) announced today that the U.S. Food and Drug Administration (FDA) has accepted Horizon’s New Drug Application (NDA) for PROCYSBI® (Cysteamine Bitartrate) Delayed-Release Oral Granules in Packets. If approved by the FDA, this new dosage form would provide another option for patients, in addition to …

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Genentech’s Gazyva Met Both Primary and Key Secondary Endpoints in Phase 2 Lupus Nephritis Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline results for NOBILITY, a Phase II clinical trial investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. The study met its primary endpoint, showing Gazyva, in …

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Farxiga Study Showed Reduced Progression of Kidney Disease or Renal Death in Patients with Type 2 Diabetes

WILMINGTON, Del.–(BUSINESS WIRE)–A pre-specified exploratory analysis of renal data from the Phase III DECLARE-TIMI 58 trial, the broadest cardiovascular outcomes trial of a sodium-glucose co-transporter 2 (SGLT2) inhibitor, showed that FARXIGA (dapagliflozin) reduced the progression of kidney disease or renal death in patients with type 2 diabetes (T2D). These data, presented …

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Study Demonstrates Ability to Predict Early Rejection in Kidney Transplant with FractalDx Portfolio Technology

NEW YORK, June 7, 2019 /PRNewswire/ — Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that positive study results have been published in the Journal of Clinical Investigation (JCI) Insight1.  These results show FractalDx portfolio technology can accurately predict early acute …

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Organovo Collaborates with MCRI and Leiden University Medical Center to Develop Stem Cell-Based Bioprinted Tissue Treatments for Kidney Disease

SAN DIEGO, May 30, 2019 (GLOBE NEWSWIRE) — Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious diseases, today announced a collaboration with Professor Melissa Little at the Murdoch Children’s Research Institute (“MCRI”), The Royal Children’s Hospital, …

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Cara Therapeutics Announces Positive Results from Phase 3 Trial of Korsuva Injection in Hemodialysis Patients with Pruritus

STAMFORD, Conn., May 29, 2019 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities with a primary focus on the treatment of pruritus by selectively targeting peripheral kappa opioid receptors, today announced positive topline data from the KALM-1 pivotal Phase 3 …

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FDA Grants Priority Review to Invokana sNDA for Treatment of Chronic Kidney Disease Patients with Type 2 Diabetes

RARITAN, N.J., May 22, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), the doubling …

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FDA Approves Bavencio Plus Inlyta Combination for First-Line Treatment of Patients with Advanced Renal Cell Carcinoma

Darmstadt, Germany and New York, US, May 14, 2019 – Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with INLYTA® …

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Fibrogen Announces Topline Results from Pooled Safety Analyses of Phase 3 Roxadustat Program

SAN FRANCISCO, May 09, 2019 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ:FGEN) today announced topline results from the pooled safety analyses of the global Phase 3 program for roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity (HIF-PHI).  The global pivotal Phase 3 trials were conducted by FibroGen and collaboration partners …

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FDA Grants Breakthrough Device Designation to Fresenius Medical Care’s Software for Fluid Management During Hemodialysis

WALTHAM, Mass., March 14, 2019 /PRNewswire/ — Fresenius Medical Care North America’s Renal Therapies Group, the leading provider of kidney care products, announced today that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to its computer-assisted ultrafiltration (UF) control software currently in development to improve fluid …

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