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Renal Diseases

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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FDA Grants Breakthrough Therapy Designation to Eisai and Merck’s Kidney Cancer Combo Therapy

TOKYO and KENILWORTH, N.J., Jan. 9, 2018 /PRNewswire/ — Eisai Co., Ltd. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) …

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FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with Inlyta in Advanced Renal Cell Carcinoma

DARMSTADT, Germany and NEW YORK, December 21, 2017 /PRNewswire/ — Second Breakthrough Therapy Designation for avelumab in hard-to-treat cancer Renal cell carcinoma, the most common form of kidney cancer, has a poor prognosis in advanced stage[1],[2] Javelin Renal clinical development program is ongoing, including Phase III first-line study Merck and …

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FDA Expands Approval of Exelixis’ Cabometyx for Previously Untreated Advanced Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC). RCC is the most common form of kidney cancer in adults. The FDA’s priority review and approval of CABOMETYX …

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