vadadustat在治疗肾性贫血患者的多项3期试验中获得积; 招商细则｜首届药代通用户交流会，邀您“医”起嗨~ 监管部门：一盒口罩500元，不违法 【全国】这30位医药人出事了！ 2015年医药市场分析及展望（处方药篇） 医保巨变，药企营销被彻底颠覆！
Vadadustat, also known as AKB-6548 and PG-1016548, is a potent Hypoxia-inducible factor-proline dioxygenase inhibitor. AKB-6548 works by inhibiting hypoxia inducible factor-prolyl hydroxylase (HIP-PH), leading to stabilization and increased levels of HIFα.
Akebia's lead product candidate, vadadustat, is an oral therapy in development for the treatment of anemia related to chronic kidney disease in both non-dialysis and dialysis patients.
Jul 28, 2017 · Three other CGRP-targeting monoclonal antibodies are speeding through late-stage testing towards potential approval, a level of R&D output that would have been surprising six years ago when Merck & Co. shut down development of its CGRP inhibitor telcagepant due to concerns over liver toxicity.
诺奖级成果罗沙司他美国上市申请进入倒计时：阿斯利康预计使用优先审评券_阿斯利康,贫血,优先审评券_罗沙司他的美国上市申请进入倒计时，非常有意思的是，2019年08月22日，阿斯利康以9500万美元从Swedish Orphan Biovitrum AB (publ) (Sobi) 购得一张
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May 11, 2020 · The FDA has accepted Genentech’s BLA for satralizumab for NMOSD in October 2019 with a PDUFA date later this year. Axcella announced positive topline data from AXA1125-003 clinical trial evaluating AXA1125 and AXA1957 in non-alcoholic fatty liver disease (NAFLD). In the non-IND study, 102 adults with NAFLD presumed to have NASH were split 2:2 ...
Jun 29, 2020 · Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD. Vadadustat is designed to mimic...
Vadadustat Published 28th December 2016, updated 4th November 2020. CCG commissioned Medicine New Medicines NHS England commissioned Renal and urologic disorders. dm+d. Unassigned New Medicines Anaemia in chronic kidney disease in patients not on dialysis and on dialysis Information. Entry type. New molecular entity.
CRL issued June 2016. NDA resubmitted with PDUFA orginally scheduled for February 8, 2017 but delayed until May 8, 2017 due to submission of additional data. Advisory Committee meeting January 10, 2018 voted 6-13 against approval.
There were no additions to the IPO calendar last week; few companies launch before a shortened holiday week. Blueprint Medicines (BPMC) was the most notable new filer, given the biotech's $100 million proposed deal size and its lead bookrunner Goldman Sachs, as the underwriter has led just two biotech IPOs since 2013: FibroGen (FGEN; +66%) and Atara Biotherapeutics (ATRA; +233%).
对于vadadustat，预计今年的销售额为200万美元，到2024年将增至15.89亿美元。 ... 依据优先审评，PDUFA的日期定为2020年6月2日。 ...