Nurses, Pharmacy and Trials - Drug Discovery Digest

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

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

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e., futility analysis).

Hospitals

Hospitals Trials Clinical Trials Production

Beginner’s Guide to Human Research Protection Programs

Advarra

SEPTEMBER 7, 2023

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. Typically, this is the office of sponsored programs or a clinical trials office. HRPPs vary widely in structure, size, and component programs and offices.

Research

Research Clinical Trials Compliance Regulations

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

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

The Pharma Data

NOVEMBER 18, 2020

“Tampa General Hospital and USF Health were already actively conducting clinical trials on COVID-19 and had the team, location and infrastructure in place to identify and care for the patients who can benefit most from this treatment.”

Hospitals

Hospitals Treatment Virus Nurses

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. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Hospitals

Hospitals Production Clinical Trials Therapies

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.

Therapies

Therapies FDA Clinical Trials Hospitals

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

The Pharma Data

JANUARY 12, 2021

“Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems,” said George D. .”

Government

Government Hospitals Virus Clinical Trials

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. Data from these trials will be used to support a future BLA submission.

FDA

FDA Clinical Trials Hospitals Production

‘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. Another COVID-19 vaccine enters final trials. A global scourge. By Thursday, the U.S.

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

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. More community centers and pharmacies will also be added to the list of places where people can be vaccinated, the Times reported.

Vaccine

Vaccine Government Virus Hospitals

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

Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. Our best expert admissibility/Rule 702 (and best trial court) decision of 2023 was issued earlier this month, shortly after the Rule 702 amendments went into effect. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

Testimonials

Testimonials FDA Drugs Vaccine

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. She came with her 21-year-old brother-in-law. Plaintiff] claimed [the defendant]. . . pharmacist. . .

Vaccine

Vaccine Pharmacy Hospitals Licensing

Drug Discovery Digest

Key Items Auditors Look for When Reviewing an Investigator Site File

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

Trending Sources

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

Beginner’s Guide to Human Research Protection Programs

Women in STEM with Charlotte Owens

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

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

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

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

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

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

Two New Appellate COVID-Related Developments

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