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Renal Diseases

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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Gilead Acquires Nimbus’ NASH Drug in $1.28 Billion Deal

FOSTER CITY, Calif. & CAMBRIDGE, Mass., April 4, 2016—Gilead Sciences, Inc. (NASDAQ: GILD) and Nimbus Therapeutics, LLC today announced that the companies have signed a definitive agreement under which Gilead will acquire Nimbus Apollo, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics …

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FDA Approves Jazz Pharmaceuticals’ Rare Liver Disease Drug

DUBLIN, March 30, 2016 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the United States (U.S.) Food and Drug Administration (FDA) granted marketing approval for Defitelio® (defibrotide sodium) for the treatment of adult and pediatric patients with hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary …

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AstraZeneca Announces Positive Late-Stage Results for the Treatment of Hyperuricemia Associated with Gout

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive subanalysis data of the Phase III lesinurad studies (CLEAR1, CLEAR2 and CRYSTAL) for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).The results demonstrated a consistent efficacy and safety profile in patients with normal renal function, as well …

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Shire’s Cinryze Receives Fast Track Status from the FDA for AMR in Kidney Transplant Patients

Lexington, MA – October 13, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CINRYZE® (C1 esterase inhibitor [human]) for intravenous administration in subjects with Antibody Mediated Rejection (AMR) in renal …

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FDA Grants Fast Track Status to Exelixis’ Kidney Cancer Drug

The US Food and Drug Administration (FDA) has granted Fast Track designation to Exelixis’ renal cell carcinoma (RCC) drug. The agency provided fast track status for Exelixis’ investigational cabozantinib for the treatment of patients with advanced RCC who have received one prior therapy. The news sent the company’s shares up …

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Hospira Presents Data Demonstrating the Biosimilarity Between Amgen’s Epogen and Hospira’s Proposed Biosimilar

Hospira, Inc. presented two studies supporting biosimilar application for Epoetin Hospira in the US. Hospira, a global leader in biosimilars and the world’s leading provider of injectable drugs and infusion technologies, presented two studies at the National Kidney Foundation (NKF) Spring Meeting. The two presentations were “PK/PD Equivalence of Epoetin …

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FDA Clears First-of-Kind Device to Treat Patients with Dialysis-Related Amyloidosis

US health regulators cleared use of a first-of-its-kind device to treat dialysis-related amyloidosis (DRA). The US Food and Drug Administration (FDA) authorized use of Lixelle Beta 2-microglobulin Apheresis Column under its pathway for medical devices that treat rare conditions. The device is used to treat DRA, a chronic, progressive condition …

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