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REGEN-COV Authorized for Postexposure Prophylaxis in High-Risk Individuals
August 05, 2021
The monoclonal antibody therapy REGEN-COV was authorized for emergency use as a postexposure prophylaxis for COVID-19 in those at high risk for severe disease, the U.S. Food and Drug Administration announced Friday.
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New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV (casirivimab and imdevimab) to Prevent SARS-CoV-2 Infection
firstwordpharma
August 05, 2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine(NEJM) published positive detailed results from a Phase 3 trial that assessed the ability of REGEN-COV™ (casirivimab and imdevimab) to prevent COVID-19.
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FDA authorizes REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19
fda.gov
August 05, 2021
The U.S. Food and Drug Administration today revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) authorizing REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19.
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FDA grants EUA for Regeneron’s antibody cocktail to prevent Covid-19
pharmaceutical-technology
August 02, 2021
The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for Regeneron Pharmaceuticals’ investigational antibody cocktail, REGEN-COV (casirivimab and imdevimab) to prevent Covid-19.
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Research body recommends COVID-19 drug
firstwordpharma
August 02, 2021
Australia's National COVID-19 Clinical Evidence Taskforce issued a new recommendation conditionally backing use of Regeneron's COVID-19 antibody cocktail REGEN-COV (casirivimab/imdevimab), as reported Sunday in This is Money.
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Antibody cocktail improves survival in seronegative hospitalised COVID-19 patients
europeanpharmaceuticalreview
June 18, 2021
Phase III data shows REGEN-COV™ (casirivimab and imdevimab) reduced risk of death by 20 percent in hospitalised COVID-19 patients lacking an immune response to SARS-CoV-2.
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REGEN-COV Phase 3 Trial Meets Primary Outcome
contractpharma
June 17, 2021
Improves survival by 20% in hospitalized COVID-19 patients lacking an immune response to SARS-CoV-2.
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FDA Authorizes Lower Intravenous and Subcutaneous Dose of REGEN-COV™ Antibody Cocktail to Treat Patients with COVID-19
americanpharmaceuticalreview
June 09, 2021
Regeneron Pharmaceuticals Inc. announced the U.S. FDA updated the Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized.
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FDA updates Regeneron’s Covid-19 antibody EUA to lower dose
pharmaceutical-technology
June 07, 2021
The US Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) for Regeneron Pharmaceuticals’ Covid-19 antibody cocktail, REGEN-COV, reducing the dose to 1,200mg from 2,400mg.
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Phase 3 Data Presented at ATS 2021 Show REGEN-COV™ (casirivimab with imdevimab) Reduced Risk of Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients
drugs
May 24, 2021
Regeneron Pharmaceuticals, Inc. today announced the presentation of detailed results from the Phase 3 pivotal trial showing REGEN–COV™ significantly reduced the risk of hospitalization or death