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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

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , View original content: [link]. Source link.

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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

Regeneron Pharmaceuticals, Inc. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19.

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

The Pharma Data

Regeneron Pharmaceuticals, Inc. Nursing Mothers: There is currently no clinical experience in use of casirivimab and imdevimab injection in COVID-19 patients who are breastfeeding. SOURCE Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the U.S. Forward-Looking Statements and Use of Digital Media.

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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

November 21, 2020 – Regeneron Pharmaceuticals, Inc. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. TARRYTOWN, N.Y., Food and Drug Administration (FDA). 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

Regeneron Pharmaceuticals, Inc. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process. 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 ). Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. Forest Pharmaceuticals, Inc.