Tag Archives: CKD

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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23 May
FDA Approves AstraZeneca’s Lokelma for Treatment of Adults with Hyperkalemia

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults. Hyperkalemia is a serious condition characterized by high levels of potassium in the blood (greater than 5.0 mEq/L).1,2,4 The risk of hyperkalemia increases …
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16 April
Boehringer Ingelheim and Lilly Collaborate with University of Oxford to Investigate Empagliflozin in Chronic Kidney Disease

INGELHEIM, Germany & INDIANAPOLIS, Ind.–(BUSINESS WIRE)–Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced an academic collaboration with the University of Oxford. EMPA-KIDNEY will investigate the effects of empagliflozin on the progression of kidney disease and the occurrence of cardiovascular death, in people with established chronic kidney disease with …
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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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26 May
FDA Panel Recommends Approval of Pfizer’s Epoetin Alfa Biosimilar Across All Indications

Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company’s proposed epoetin alfa biosimilar across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a U.S. FDA …
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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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