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Aurinia’s Voclosporin Demonstrates Superiority Over Standard of Care in Phase 3 Lupus Nephritis Trial

VICTORIA, British Columbia–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) …

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Cara Therapeutics Announces Positive Topline Data from Mid-Stage Trial of Oral Korsuva in CKD Patients with Moderate-to-Severe Pruritus

STAMFORD, Conn., Dec. 03, 2019 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, today announced positive topline results from its Phase 2 dose-ranging trial of Oral KORSUVA™ (CR845/difelikefalin) …

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Ardelyx Announces Positive Results from its Phase 3 Study Evaluating Tenapanor in CKD Patients on Dialysis

FREMONT, Calif., Dec. 3, 2019 /PRNewswire/ — Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive topline results from PHREEDOM, a long-term Phase 3 study evaluating the efficacy and safety of tenapanor as monotherapy for …

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FDA Grants Fast Track Designation to AstraZeneca’s Farxiga for Treatment of Chronic Kidney Disease

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD). The FDA’s Fast Track program …

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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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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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Gilead Sciences and Goldfinch Bio Enter Strategic Collaboration for Development of Novel Therapies for Kidney Disease

FOSTER CITY, Calif. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Goldfinch Bio, Inc., a biotechnology company focused on developing precision therapies for patients with kidney diseases, today announced a strategic collaboration to discover, develop and commercialize a pipeline of innovative therapeutics for diabetic kidney disease (DKD) and certain orphan kidney …

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FDA Grants Breakthrough Device Designation to KidneyIntelX, AI-Enabled Diagnostic for Kidney Disease

NEW YORK, May 2, 2019 /PRNewswire/ — Renalytix AI plc (LON: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX™. This is the first such …

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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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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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