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Nephrology

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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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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Breast and Cervical Cancer Screening Rates Low in Women With Advanced Kidney Disease

Washington, DC (December 29, 2016) — A new study indicates that many women with advanced kidney disease are not receiving recommended breast or cervical cancer screening, even though they face a higher risk of developing cancer than women in the general population. The findings appear in an upcoming issue of …

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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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Investigating Kidney Biomarkers to Track Lupus

ANN ARBOR, Mich. – Lupus, a chronic autoimmune disease, can wreak havoc on an affected individual’s body through inflammation, pain and even damage of the skin, joints and organs. To try to better understand how the disease begins and progresses, researchers at the University of Michigan investigated whether kidney biomarkers …

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Gilead Discontinues PAH and DKD Tests After Mid-Stage Failure; Advances NASH Treatment into Phase III Trials

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 20, 2016– Gilead Sciences, Inc.(Nasdaq:GILD) today announced the top-line results from three Phase 2 studies of GS-4997 (selonsertib), an investigational inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in nonalcoholic steatohepatitis (NASH), pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). GS-4997 demonstrated anti-fibrotic activity in an …

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Retrophin’s Sparsentan Demonstrates Positive Mid-Stage Results in Patients with a Rare Kidney Disorder

SAN DIEGO, Sept. 07, 2016 (GLOBE NEWSWIRE) — Retrophin, Inc. (NASDAQ:RTRX) today announced positive top-line results from the Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disorder without an approved pharmacologic treatment that often leads to end-stage renal disease. The study achieved …

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FDA Rejects Amgen’s Next-Generation Chronic Kidney Disease Drug

THOUSAND OAKS, Calif., Aug. 24, 2016 /PRNewswire/ — Amgen (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv™ (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease …

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Celldex Initiates Phase 1/2 Clinical Trial of New Product Candidate in Advanced RCC

HAMPTON, N.J., July 11, 2016 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that enrollment has opened in its Phase 1/2 study of CDX-014 in advanced renal cell carcinoma (RCC). CDX-014 is a novel antibody-drug conjugate that targets the transmembrane protein T-cell immunoglobulin mucin-1 (TIM-1). TIM-1 expression is upregulated …

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Aurinia’s Lupus Nephritis Drug Awarded FDA Fast Track Designation

VICTORIA, British Columbia–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for voclosporin, the Company’s next generation calcineurin inhibitor, for the treatment of Lupus Nephritis (LN). The Fast Track program was created by …

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