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Renal Diseases

FDA Rejects AstraZeneca’s Hyperkalemia Drug

AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate). Sodium zirconium cyclosilicate is being developed for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. Hyperkalaemia is …

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Ardelyx’s Tenapanor Demonstrates Positive Results in Late-Stage Trial for Hyperphosphatemia in Patients with ESRD

FREMONT, Calif., Feb. 15, 2017 /PRNewswire/ — Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage company focused on enhancing the treatment of patients with cardiorenal and gastrointestinal (GI) diseases, today reported that the Phase 3 clinical trial evaluating the efficacy and safety of tenapanor as a treatment for hyperphosphatemia in patients with end-stage …

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FDA Accepts CSL Behring’s sBLA for Privigen for Treatment of Chronic Inflammatory Demyelinating Polyneuropathy

Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s clinical efficacy supplement to its Biologics License Application (BLA) for Privigen® [Immune Globulin Intravenous (Human), 10% Liquid], its intravenous immunoglobulin (IVIg). The supplement seeks to obtain approval for a …

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FDA Approves Amgen’s Parsabiv for Secondary Hyperparathyroidism in Patients with CKD on Hemodialysis

THOUSAND OAKS, Calif., Feb. 7, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first therapy approved for this condition in …

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Alexion’s Soliris Fails to Meet Primary Endpoint in Mid-Stage Study in Kidney Transplant Patients

December 21, 2016 04:04 PM Eastern Standard Time NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today reported results from the PROTECT Study, a Phase 2/3 registration trial of eculizumab (Soliris®) for the prevention of delayed graft function (DGF) after kidney transplantation in adult recipients of a deceased donor kidney. …

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Regulus Announces the Addition of New Liver and Kidney Disease Candidates to its Pipeline

LA JOLLA, Calif., Dec. 6, 2016 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced two new drug development candidates at its R&D day, held in New York. The first candidate, RGLS5040, is an anti-miR targeting microRNA-27 …

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Arrowhead Pharma Halts Work on Lead Hepatitis B Drugs, Focuses on Subcutaneous and Extra-Hepatic RNAi Therapeutics

PASADENA, Calif.–(BUSINESS WIRE)–Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced a strategic redeployment of resources to support the development of RNAi therapeutics that utilize the company’s new proprietary subcutaneous (subQ) and extra-hepatic delivery systems. Arrowhead will discontinue development of clinical stage drug candidates ARC-520, ARC-521, and ARC-AAT, which utilize the DPCiv™, …

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Alexion Announces that Data from Global aHUS Registry Shows Reduced Risk with Soliris

NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced today that researchers presented new data from an analysis of patients enrolled in the Global atypical Hemolytic Uremic Syndrome (aHUS) Registry, demonstrating that initiation of Soliris® (eculizumab) prior to kidney transplant reduces the risk of dialysis post-transplant in patients with aHUS. Specifically, …

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Exelixis’ Kidney Cancer Drug Beats Pfizer’s Sutent in Mid-Stage Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Oct. 10, 2016– Exelixis, Inc.(NASDAQ:EXEL) today announced detailed results from the CABOSUN randomized phase 2 trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Principal investigator Toni …

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FDA Approves OPKO Health’s Rayaldee for CKD-Related Secondary Hyperparathyroidism

MIAMI–(BUSINESS WIRE)– OPKO Health, Inc. (NYSE:OPK) announced that the U.S. Food and Drug Administration (FDA) has approved RAYALDEE®(calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. RAYALDEE …

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