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Renal Diseases

FDA Grants Breakthrough Therapy Designation to Eisai and Merck’s Kidney Cancer Combo Therapy

TOKYO and KENILWORTH, N.J., Jan. 9, 2018 /PRNewswire/ — Eisai Co., Ltd. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) …

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FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with Inlyta in Advanced Renal Cell Carcinoma

DARMSTADT, Germany and NEW YORK, December 21, 2017 /PRNewswire/ — Second Breakthrough Therapy Designation for avelumab in hard-to-treat cancer Renal cell carcinoma, the most common form of kidney cancer, has a poor prognosis in advanced stage[1],[2] Javelin Renal clinical development program is ongoing, including Phase III first-line study Merck and …

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FDA Expands Approval of Exelixis’ Cabometyx for Previously Untreated Advanced Renal Cell Carcinoma

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC). RCC is the most common form of kidney cancer in adults. The FDA’s priority review and approval of CABOMETYX …

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FDA Grants Priority Review to the sBLA for Opdivo Plus Yervoy for the Treatment of Advanced Renal Cell Carcinoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for …

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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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