September 25, 2023
GSK gets Japan’s approval for RSV vaccine for older adults
Japan’s Ministry of Health, Labour and Welfare has approved GSK’s Arexvy, the country’s first respiratory syncytial virus (RSV) vaccine for older adults.
Pharmaceuticals, Biotechnology and Life Sciences
Tag: GSK
April 20, 2022
GSK’s Daprodustat Receives FDA Filing Acceptance
The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for GlaxoSmithKline’s daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD).
April 13, 2022
GSK Buys Sierra Oncology for $1.9bn
GlaxoSmithKline plc (LSE/NYSE: GSK) and Sierra Oncology, Inc (Nasdaq: SRRA) have entered into an agreement under which GSK will acquire Sierra Oncology, a California-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash representing an approximate total equity value of $1.9 billion (£1.5 billion).
April 6, 2022
GSK-Vir’s Sotrovimab No Longer Authorized to Treat COVID-19 in U.S.
FDA said that GSK’s sotrovimab is not authorized in any U.S. state or territory at this time, as CDC’s data showed the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant.
December 10, 2021
Medicago, GSK report primary and secondary endpoints with available data met in trial dominated by COVID-19 variants
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) today announce positive efficacy and safety results from the global Phase 3 placebo-controlled efficacy study of Medicago’s plant-based COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, conducted in over 24,000 subjects, adults 18y and above, across six countries.
December 7, 2021
Medicago and GSK receive good news for its plant-based COVID-19 vaccine candidate
Medicago, a biopharmaceutical company headquartered in Quebec City, and GlaxoSmithKline (GSK) have received positive efficacy and safety results from the global Phase 3 placebo-controlled efficacy study of Medicago’s plant-based COVID-19 vaccine candidate in combination with GSK’s pandemic adjuvant, conducted in over 24,000 subjects, adults 18 years and above, across six countries.
October 11, 2021
Sandoz completes acquisition of GSK’s cephalosporin business
Sandoz, a Novartis division, has acquired rights to three established brands (Zinnat, Zinacef and Fortum) in more than 100 markets,…
May 4, 2021
ViiVHC kicked off rolling submission for investigational therapy for HIV prevention
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced the initiation of a rolling submission of a new drug application (NDA) with the US Food and Drug Administration (FDA) for investigational, long-acting, injectable cabotegravir for the prevention of HIV, also called pre-exposure prophylaxis, or PrEP.
March 31, 2021
GSK to support manufacture of Novavax’ COVID-19 vaccine
GSK has reached an agreement in principle with Novavax and the UK Government Vaccines Taskforce to support manufacturing of up…
June 12, 2020
FDA approves ViiV Healthcare’s dolutegravir tablet for children living with HIV
ViiV Healthcare Friday said that the US Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) tablets for oral suspension, used combined with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in certain young patients.