Remove Hospitals Remove Licensing Remove Pharmacy Remove Virus
article thumbnail

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

The Pharma Data

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

article thumbnail

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

The Pharma Data

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. “The investigational cocktail is now available to indicated high-risk U.S.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

(NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. About the REGN-COV2 Trial in Hospitalized Patients. Cohort 1A: patients not requiring oxygen.

article thumbnail

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

The Pharma Data

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19.

article thumbnail

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 There was a 1.08

Virus 40
article thumbnail

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

The Pharma Data

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the U.S. Yancopoulos , M.D.,

article thumbnail

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. Eiger licensed exclusive worldwide rights to lonafarnib from Merck, known as MSD outside of the United States and Canada. Four (8%) patients reported severe diarrhea. Outside the U.S.,