Tag Archives: Chronic Kidney Disease

December, 2018

20 December
FibroGen Announces Positive Topline Results from Three Phase 3 Trials of Roxadustat for Treatment of Anemia in Patients with CKD

SAN FRANCISCO, Dec. 20, 2018 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ:FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, today announced that roxadustat, an inhibitor of hypoxia-inducible-factor (HIF) prolyl hydroxylase activity (HIF-PHI), met all primary efficacy endpoints in the three global pivotal Phase 3 trials conducted …
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31 May
Baxter and Mayo Collaborate to Transform Patient Care

DEERFIELD, Ill. & JACKSONVILLE, Fla.–(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), a global medical products company, and Mayo Clinic today announced a new research and development collaboration to advance innovation across a spectrum of therapeutic areas where there are high unmet patient needs. The collaboration agreement will bring together the clinical and …
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17 March
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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8 February
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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2 January
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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26 August
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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22 June
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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6 November
AstraZeneca Boosts its Pipeline with $2.7 Billion Acquisition of ZS Pharma

AstraZeneca announced today that it has entered into a definitive agreement to acquire ZS Pharma (NASDAQ: ZSPH), a biopharmaceutical company based in San Mateo, California. ZS Pharma uses its proprietary ion-trap technology to develop novel treatments for hyperkalaemia (high potassium levels), a serious condition of elevated potassium in the bloodstream, …
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