Hospitals, Nurses, Pharmacy and Trials

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

The Pharma Data

NOVEMBER 5, 2020

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. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Hospitals

Hospitals Trials Clinical Trials Production

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

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

Hospitals Trials Clinical Trials Production

Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

APRIL 30, 2024

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Below are examples of key items auditors/inspectors look for during an audit.

Licensing

Licensing Licensing Pharmacy FDA

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

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

Hospitals Production Clinical Trials Virus

Women in STEM with Charlotte Owens

Drug Target Review

AUGUST 16, 2024

These barriers stem from a variety of reasons, including high cost, medical mistrust, pharmacy and provider access, historical inequities and racial discrimination. In those roles, she oversaw the direction, planning, execution and interpretation of clinical trial data.

Medical Schools

Medical Schools Nurses Research Production

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

The Pharma Data

JANUARY 12, 2021

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. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials. Yancopoulos , M.D.,

Government

Government Hospitals Virus Production

Tampa General Hospital is First in Florida To Offer Monoclonal Antibody Treatments to COVID-19 Patients

The Pharma Data

NOVEMBER 18, 2020

18, 2020 /PRNewswire/ — Tampa General Hospital provided the first monoclonal antibody treatment to a COVID-19 positive patient today. Eli Lilly and Company’s antibody therapeutic will be distributed as part of the federal government’s Operation Warp Speed. . TAMPA, Fla., For more information, visit health.usf.edu.

Hospitals

Hospitals Treatment Virus Nurses

Beginner’s Guide to Human Research Protection Programs

Advarra

SEPTEMBER 7, 2023

This can include independent IRBs or those at other academic medical centers or hospitals. This includes the IRB or EC, sponsored research, and the clinical trials office – when a COI is identified, HRPP staff can collaborate to determine appropriate management. HRPPs vary widely in structure, size, and component programs and offices.

Research

Research Compliance Clinical Trials Regulations

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

The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos, M.D.,

Therapies

Therapies FDA Clinical Trials Hospitals

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

The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron.

FDA

FDA Clinical Trials Hospitals Government

‘Warp Speed’ Officials Say U.S. COVID Vaccine Distribution Too Slow

The Pharma Data

DECEMBER 31, 2020

Right now, most shots are being given at hospitals, clinics and nursing homes, but Perna and Slaoui agreed that the pace of vaccination should pick up considerably once doses are given out by the major pharmacy chains. But a faster-spreading virus could swamp hospitals with seriously ill patients. A global scourge.

Vaccine

Vaccine Long-Term Care Facilities Virus Hospitals

COVID Daily Death Toll Sets New U.S. Record, Soars Past 4,400

The Pharma Data

JANUARY 13, 2021

. “Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied.” Right now, the vaccines are largely being distributed to people in the highest-risk categories, including frontline health care workers and older people and staff in nursing homes.

Vaccine

Vaccine Government Virus Nurses

Two New Appellate COVID-Related Developments

Drug & Device Law

MAY 15, 2023

The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent. includ[es] retail pharmacies. UPMC Pinnacle Hospitals , 283 A.3d Presence Center & Suburban Hospitals Network , 191 N.E.3d.

Vaccine

Vaccine Pharmacy Hospitals Licensing

Drug Discovery Digest

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

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

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Key Items Auditors Look for When Reviewing an Investigator Site File

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

Women in STEM with Charlotte Owens

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

Tampa General Hospital is First in Florida To Offer Monoclonal Antibody Treatments to COVID-19 Patients

Beginner’s Guide to Human Research Protection Programs

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

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

‘Warp Speed’ Officials Say U.S. COVID Vaccine Distribution Too Slow

COVID Daily Death Toll Sets New U.S. Record, Soars Past 4,400

Two New Appellate COVID-Related Developments

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