Renal Diseases

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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Natera Announces Publication of Analytical Validation Study Demonstrating Superior Precision of Its Kidney Transplant Rejection Assay

SAN CARLOS, Calif., Feb. 22, 2019 /PRNewswire/ –Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA, today announced analytical validation study results to be published online in the journal  Transplantation demonstrating the superior performance of its donor-derived cell-free DNA (dd-cfDNA) test for detecting active rejection in kidney transplant recipients.1 The study showed superior assay …

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FDA Grants Breakthrough Device Designation to AWAK Technologies’ Wearable Peritoneal Dialysis Device

SINGAPORE, Jan. 11, 2019 /PRNewswire/ — AWAK Technologies (AWAK), a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and …

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Natera Announces Publication of Kidney Transplant Validation Study, Demonstrating Superior Data in Detecting Clinical and Subclinical Rejection

SAN CARLOS, Calif., Jan. 7, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in cell-free DNA, today announced clinical validation study results published in the Journal of Clinical Medicine,1 demonstrating the highly accurate performance of its donor-derived cell-free DNA (dd-cfDNA) test for active allograft rejection in kidney transplant recipients, including higher sensitivity and nearly 18% …

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Researchers Discover Kidney Disease Gene Affects More Populations Than Previously Thought

New York, NY (December 27, 2018) — In the largest population genomics investigation to date, a team of researchers at the Icahn School of Medicine at Mount Sinai, Stanford University, and the University of Colorado have discovered that kidney disease risk variants of the gene APOL1, previously known to affect …

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FibroGen Announces Positive Topline Results from Three Phase 3 Trials of Roxadustat for Treatment of Anemia in Patients with CKD

SAN FRANCISCO, Dec. 20, 2018 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ:FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, today announced that roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity (HIF-PHI), met all primary efficacy endpoints in the three global pivotal Phase 3 trials conducted …

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Amicus Acquires Gene Therapy Portfolio of Ten AAV Programs in Neurologic Lysosomal Storage Disorders

CRANBURY, N.J., Sept. 20, 2018 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD) today announced the signing of a definitive agreement in which Amicus Therapeuticswill receive worldwide development and commercial rights for ten gene therapy programs developed at The Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital and The Ohio State University. The ten programs are licensed …

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