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Renal Diseases

Alnylam’s Rare Disease Drug Demonstrates Positive Results in Ongoing Phase 1/2 Study

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today positive preliminary data from its ongoing Phase 1/2 study with lumasiran (formerly known as ALN-GO1), an investigational RNAi therapeutic targeting glycolate oxidase (GO) for the treatment of Primary Hyperoxaluria Type 1 (PH1). Results were presented today at …

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Bristol-Myers Squibb’s Kidney Cancer Drug Met Co-Primary Endpoint in Late-Stage Trial

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced topline results today from the CheckMate -214 trial investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma. The combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR …

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Exelixis Submits sNDA for Cabometyx for the Treatment of Previously Untreated Advanced Kidney Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced it has completed the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX®(cabozantinib) tablets as a treatment for patients with previously untreated advanced renal cell carcinoma (RCC). The sNDA submission is based on …

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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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