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Renal Diseases

FDA Approves Invokana to Treat Diabetic Kidney Disease (DKD) and Reduce the Risk of Hospitalization for Heart Failure in T2D and DKD

RARITAN, N.J., Sept. 30, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in …

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AzurRx BioPharma Announces Positive Results from Phase 2 Trial of MS1819 in Cystic Fibrosis Patients

NEW YORK, Sept. 25, 2019 (GLOBE NEWSWIRE) — AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced positive safety results from its Phase II OPTION Clinical Trial of MS1819 for the treatment of exocrine pancreatic insufficiency …

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FDA Grants Breakthrough Therapy Designation for Genentech’s Gazyva for Treatment of Lupus Nephritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Gazyva® (obinutuzumab) for adults with lupus nephritis. This designation was granted based on data from the Phase II …

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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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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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