Tag: GSK

April 20, 2022 Off

GSK’s Daprodustat Receives FDA Filing Acceptance

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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 Off

GSK Buys Sierra Oncology for $1.9bn

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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).

December 10, 2021 Off

Medicago, GSK report primary and secondary endpoints with available data met in trial dominated by COVID-19 variants

By Dino Mustafić

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 Off

Medicago and GSK receive good news for its plant-based COVID-19 vaccine candidate

By Dino Mustafić

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.

May 4, 2021 Off

ViiVHC kicked off rolling submission for investigational therapy for HIV prevention

By Dino Mustafić

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.