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RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

The trial is supported by a grant to the University of Oxford from UK Research and Innovation / National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre , Wellcome , the Bill and Melinda Gates Foundation , the Department for International Development , Health Data Research UK , the (..)

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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 in patients 12 years of age and older and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

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Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

The companies share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations. None of the SAEs were considered to be related to study drug.

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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

Food and Drug Administration (FDA) in high-risk patients who have confirmed COVID-19 but are not currently hospitalized. None of the SAEs were considered to be related to study drug. Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding.

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Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

Food and Drug Administration (FDA). None of the SAEs were considered to be related to study drug. Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding. About Regeneron.

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Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

Food and Drug Administration (FDA). None of the SAEs were considered to be related to study drug. Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding.

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. United States Department of Health and Human Services , 58 F.4th 4th 696 (3d.