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Libtayo Monotherapy Trial in Advanced Cervical Cancer Stopped Early for OS Positive Result
americanpharmaceuticalreview
March 22, 2021
Regeneron Pharmaceuticals and Sanofi announced positive results demonstrating an overall survival (OS) benefit from the Phase 3 trial investigating the PD-1 inhibitor Libtayo® (cemiplimab) monotherapy compared to chemotherapy, in patients previously ...
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Sanofi, Regeneron’s Libtayo improves survival in cervical cancer patients
pharmatimes
March 15, 2021
Sanofi and Regeneron’s PD-1 inhibitor Libtayo has demonstrated positive overall survival (OS) results in a Phase III trial in advanced cervical cancer.
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FDA Accepts Dupixent for Review in Children with Moderate-to-severe Asthma
americanpharmaceuticalreview
March 09, 2021
Regeneron Pharmaceuticals and Sanofi announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years ...
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Panel finds efficacy for Regeneron’s REGEN-COV in Phase III Covid-19 trial
pharmaceutical-technology
March 01, 2021
Regeneron Pharmaceuticals has announced that Independent Data Monitoring Committee (IDMC) found its REGEN-COV antibody cocktail to have clear clinical efficacy in cutting down the rates of hospitalisation and deaths in patients in a Phase III Covid-19 ...
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FDA Approves Evkeeza
americanpharmaceuticalreview
February 22, 2021
Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 ...
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Regeneron 4Q and FY20 Results
contractpharma
February 07, 2021
REGEN-COV antibody cocktail for COVID-19 received FDA EUA; Net sales of REGEN-COV were $146 million in the quarter and $186 million for the year.
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EMA initiates rolling review of Regeneron’s COVID-19 mAb
europeanpharmaceuticalreview
February 03, 2021
The EMA’s CHMP has begun a rolling review of REGN-COV2, Regeneron’s COVID-19 antibody candidate, after successful pre-clinical trials.
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REGEN-COV prevents symptomatic COVID-19 infections, finds analysis
europeanpharmaceuticalreview
January 28, 2021
Interim data from the Phase III trial evaluating REGEN-COV™ as a passive vaccine to prevent COVID-19 finds it reduces overall infection rate, viral load and length of infection.
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US could purchase over 1.5 million doses of Regeneron’s COVID-19 antibody cocktail
europeanpharmaceuticalreview
January 19, 2021
The additional doses of casirivimab and imdevimab, two monoclonal antibodies, will be used in non-hospitalised COVID-19 patients.
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Regeneron Announces Initial Data from COVID-19 Antibody Cocktail Trial
americanpharmaceuticalreview
December 31, 2020
Regeneron Pharmaceuticals has announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen.