Why a kidney disease drug approval in China is just the start for this S.F. company

To win its first-ever drug approval, FibroGen Inc. turned to China, but it's not going to be the San Francisco company's last stop. China's drug regulatory agency Monday approved roxadustat, the first drug of its kind for dialysis patients with anemia caused by chronic kidney disease. San Francisco-based FibroGen's (NASDAQ: FGEN) China subsidiary will manufacture the tablet and partner AstraZeneca plc (NYSE: AZN) will sell the drug starting in the second-half of 2019. But roxadustat's win in China…
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news

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This article aims to establish the suitable hemoglobin in order to provide clinical guidance. METHODS: MEDLINE, EmBase, the Cochrane Library and other databases were searched with both MeSH terms and keywords to gather randomized controlled trials that assessed all-cause mortality, cardiovascular events, fistula thrombosis, infectious diseases and transfusion among dialysis-dependent patients using erythropoiesis-stimulating agents. The meta-analysis was accomplished via Revman 5.3 version. FINDINGS: Totally, nine eligible studies were included, with study subjects involving 3228 patients. There was a significantly...
Source: Renal Failure - Category: Urology & Nephrology Tags: Ren Fail Source Type: research
Vadadustat is a potential new treatment for anemia in chronic kidney disease -- but what do we know about its impacts in patients receiving hemodialysis?Nephrology Dialysis Transplantation
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Nephrology Journal Article Source Type: news
Conclusions: Enarodustat corrects and maintains Hb levels in anemic patients with CKD not on dialysis.Am J Nephrol 2019;49:165 –174
Source: American Journal of Nephrology - Category: Neurology Source Type: research
CONCLUSIONS: Enarodustat corrects and maintains Hb levels in anemic patients with CKD not on dialysis. PMID: 30699415 [PubMed - as supplied by publisher]
Source: American Journal of Nephrology - Category: Urology & Nephrology Authors: Tags: Am J Nephrol Source Type: research
Conclusions: Higher MCV was associated with higher all-cause, cardiovascular, and infectious mortality in HD patients. Further investigation is necessary to understand the underlying nature of the observed association.Nephron
Source: Nephron - Category: Urology & Nephrology Source Type: research
Erythropoiesis-stimulating agents (ESAs) are frequently used among patients with renal anemia, while a significant proportion of patients exhibit ESA hyporesponsiveness despite adequate dosing. Previous studies have suggested an inverse association between ESA hyporesponsiveness and statin use among patients receiving dialysis therapy. However, studies based on predialysis patients are extremely limited. Based on electronic medical records of a tertiary hospital in Beijing, China between April 2010 and April 2015, we investigated the association between statin use and ESA hyporesponsiveness among patients with predialysis...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
Authors: Lee JH, Chung BH, Joo KW, Shin SK, Kim YL, Na KY, Do JY, Park SK, Shin BC, Lee JS, Kim YW, Kim SW, Lee KW, Kang GW, An WS, Shin GT, Han S, Yang CW Abstract OBJECTIVE: To evaluate the efficacy and safety of CKD-11101 (biosimilar darbepoetin-alfa, Chong Kun Dang Pharm.) compared with NESP® in treatment of anaemia in patients with chronic kidney disease not on dialysis. CLINICAL TRIAL REGISTRATION: NCT03431623. METHOD: In this multicentre, randomized, double-blind study, patients were treated with CKD-11101 and NESP. The efficacy evaluation period (EEP) was 24 weeks, during which patients were tre...
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research
Publication date: Available online 19 December 2018Source: American Journal of Kidney DiseasesAuthor(s): Finnian R. Mc Causland, Brian Claggett, Emmanuel A. Burdmann, Glenn M. Chertow, Mark E. Cooper, Kai-Uwe Eckardt, Peter Ivanovich, Andrew S. Levey, Eldrin F. Lewis, Janet B. McGill, John J.V. McMurray, Patrick Parfrey, Hans-Henrik Parving, Giuseppe Remuzzi, Ajay K. Singh, Scott D. Solomon, Robert D. Toto, Marc A. PfefferRationale &ObjectiveEvidence from clinical trials to guide patient preparation for maintenance dialysis therapy is limited. Although anemia is associated with mortality and cardiovascular (CV) disease...
Source: American Journal of Kidney Diseases - Category: Urology & Nephrology Source Type: research
CONCLUSIONS: The overall phase 2 efficacy and safety profile of molidustat in patients with CKD and anemia enables the progression of its development into phase 3. PMID: 30559105 [PubMed - as supplied by publisher]
Source: Clinical Journal of the American Society of Nephrology : CJASN - Category: Urology & Nephrology Authors: Tags: Clin J Am Soc Nephrol Source Type: research
Publication date: Available online 13 December 2018Source: The Lancet HIVAuthor(s): Joseph J Eron, Jean-Daniel Lelievre, Robert Kalayjian, Jihad Slim, Anson K Wurapa, Jeffrey L Stephens, Cheryl McDonald, Eric Cua, Aimee Wilkin, Brigitte Schmied, Mehri McKellar, Stephanie Cox, Sophia R Majeed, Shuping Jiang, Andrew Cheng, Moupali Das, Devi SenGuptaSummaryBackgroundCurrent treatment for HIV-infected individuals with renal failure on haemodialysis frequently requires complex regimens with multiple pills. A daily single-tablet regimen of coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is approve...
Source: The Lancet HIV - Category: Infectious Diseases Source Type: research
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