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Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19

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Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19
Vir Biotechnology and GSK Announce Start of NIH-Sponsored ACTIV-3 Trial Evaluating VIR-7831 in Hospitalized Adults with COVID-19
– Randomized, placebo-controlled, multicenter, global Phase 3 trial will investigate the safety and efficacy of VIR-7831 in hospitalized adults with COVID-19 –
SAN FRANCISCO and LONDON, Dec. 17, 2020 Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 (also known as GSK4182136) is a f ....

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FDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US

FDA approves GSK s BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US
Approval builds on nearly 10 years of experience in lupus
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LONDON, Dec. 17, 2020 /PRNewswire/ GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the US to include both SLE and LN for both the intravenous and subcutaneous formulations. ....

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ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with mult

ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with mult
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ViiV Healthcare meldet positive Stellungnahme des Ausschusses für Humanarzneimittel zu Rukobia (Fostemsavir), dem ersten Attachment-Inhibitor seiner Wirkstoffklasse zur Behandlung von Erwachsenen mit multiresistenter HIV-1-Infektion bei wenigen...

ViiV Healthcare meldet positive Stellungnahme des Ausschusses für Humanarzneimittel zu Rukobia (Fostemsavir), dem ersten Attachment-Inhibitor seiner Wirkstoffklasse zur Behandlung von Erwachsenen mit multiresistenter HIV-1-Infektion bei wenigen...
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ViiV Healthcare Announces Positive CHMP Opinion for Rukobia (fostemsavir), a First-in-Class Attachment Inhibitor for the Treatment of Adults With Multidrug-Resistant HIV With Few Treatment Options Available

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Findings from pivotal phase III BRIGHTE study demonstrated that the majority (60%) of heavily treatment-experienced adults randomised to receive fostemsavir with an optimised background therapy achieved and maintained viral suppression at 96 weeks
Fostemsavir addresses a critical unmet need in HIV care for those with little to no treatment options left
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ( GSK ), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Rukobia (fostemsavir) 600 mg extended-release tablets, a novel attachment inhibitor for the treatment of HIV-1 infection. Fostemsavir, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to constr ....

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