(IN BRIEF) GSK’s marketing authorisation application for linerixibat, an investigational ileal bile acid transporter inhibitor, has been accepted for review by the European Medicines Agency. The submission is supported by GLISTEN Phase III trial data showing that linerixibat rapidly and … Read the full press release
Posted in Business, Healthcare, Pharma & Biotech, United Kingdom
Tagged alcohol-related liver disease, bile acid transporter, cholestatic pruritus, chronic hepatitis B, EASL Congress, EMA, European Medicines Agency, FDA, GLISTEN trial, GSK, IBAT inhibitor, itch-related sleep interference, Kaivan Khavandi, linerixibat, Marketing Authorisation Application, MASH, NCT04950127, orphan drug designation, PBC, Phase III, primary biliary cholangitis, UK regulatory review
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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