Submission for the treatment of anaemia of chronic kidney disease based on the ASCEND Phase III clinical trial programme, consisting of five trials that all met their co-primary efficacy and safety endpoints EMA file acceptance is the first major regulatory … Read the full press release
Posted in Healthcare, Marketing, News, Pharma & Biotech, United Kingdom
Tagged American Society of Nephrology, anaemia, ASCEND Phase III clinical trial programme, ASCEND-D, ASCEND-ND, Chronic kidney disease, CKD, daprodustat, dialysis, EMA, European Medicines Agency, GlaxoSmithKline, haemoglobin, HIF-PHI, MAA, Marketing Authorisation Application, prolyl hydroxylase inhibitor, treatment of anaemia
London, UK, 23-10-2013 — /EuropaWire/ — ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. This New Drug … Read the full press release
Posted in Government, Healthcare, Pharma & Biotech, Science, United Kingdom
Tagged abacavir, antiretroviral agents, David Daley, dolutegravir, Gary Davies, GlaxoSmithKline, GSK, HIV, HIV-1, James Dodwell, Jeff McLaughlin, lamivudine, Lucy Budd, Marc Meachem, Marketing Authorisation Application, Melinda Stubbee, New Drug Application (NDA), people living with HIV, Pfizer, Rebecca Hunt, single-tablet regimen, Tivicay®, Tom Curry, treatment of HIV-1, US Food and Drug Administration (FDA), US regulatory submission, ViiV Healthcare, Ziba Shamsi
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