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Nephrology

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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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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FDA Approves AstraZeneca’s Lokelma for Treatment of Adults with Hyperkalemia

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition characterized by high levels of potassium in the blood (greater than 5.0 mEq/L).1,2,4 The risk of hyperkalemia increases …

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FDA Approves Otsuka’s Jynarque as the First Treatment to Slow Kidney Function Decline in Patients at Risk of Rapidly Progressing ADPKD

TOKYO–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a genetic disease with consequences that can lead …

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Boehringer Ingelheim and Lilly Collaborate with University of Oxford to Investigate Empagliflozin in Chronic Kidney Disease

INGELHEIM, Germany & INDIANAPOLIS, Ind.–(BUSINESS WIRE)–Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced an academic collaboration with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with …

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