The Pharma Data

DECEMBER 29, 2020

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. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

DECEMBER 17, 2020

(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.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

The Pharma Data

OCTOBER 30, 2020

(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.

Hospitals 52

Hospitals Virus Production Clinical Trials 52

Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

The Pharma Data

NOVEMBER 20, 2020

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.

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

OCTOBER 28, 2020

REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). Senior Vice President and Head of Global Clinical Development at Regeneron. The Phase 3 portion of this trial continues in non-hospitalized patients.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

NOVEMBER 5, 2020

. “Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

Production 52

Production FDA FDA Approval Trials 52