Clinical Trials, Licensing and Nurses - Clinical Research Informer

Integrate RBQM Into Each Phase of the Clinical Trial “House”

WCG Clinical

JULY 11, 2023

Risk-based quality management (RBQM) isn’t something you merely add to an existing clinical trial. That is what we really should be basing the foundation of all our clinical trials on.” The “construction crew” should include more than the clinical operations team.

Clinical Trials

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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. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

Licensing

Licensing Licensing Pharmacy Clinical Trials

OncoHealth Expands Its Iris Platform for Digital Cancer Care

XTalks

JULY 21, 2023

During the pilot phase, 43 percent of members actively engaged with the Iris clinical team, which comprises nurses and mental health experts, with an average of 2.3 Last year, OncoHealth launched an innovative pilot program for its groundbreaking digital health service, designed to support members undergoing cancer treatment.

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NICE backs Astellas’ oral therapy Evrenzo for anaemia in kidney disease

pharmaphorum

JUNE 15, 2022

Evrenzo – originally developed by FibroGen – is licensed to Astellas in Europe, where it was approved by authorities in the UK and EU last year. The drug works by activating the body’s natural response to reduced oxygen levels in the blood, increasing red blood cell production.

Nurses

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

The Pharma Data

NOVEMBER 5, 2020

About the Trial The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Trials

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Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

Pfizer

JANUARY 27, 2023

telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply: Sufficient information is not available to assess renal and hepatic function.

Marketing

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EISAI PUBLISHES SOCIETAL VALUE OF LECANEMAB USING PHASE 3 CLARITY AD DATA IN PEER-REVIEWED NEUROLOGY AND THERAPY JOURNAL

The Pharma Data

MARCH 20, 2023

outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services), the societal perspective further considers societal costs (e.g., Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

Antibody

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Ep. 003 – Ritesh Patel Podcast Transcript

Pharma Marketing Network

JUNE 10, 2020

Those things have always stayed in the licensing side of the business, that business that either went and acquired a molecule or licensed to molecule. or change the way I do clinical trials or change the way I actually do clinical recruitment? Now to get somebody into a clinical trial.

Marketing

Marketing Clinical Trials Clinical Trials Nurses

18 products ALTERNATIVE to PARACETAMOL

Druggist

JANUARY 15, 2021

Paracetamol: licensed use and limit on the sale . Paracetamol – licensed use . Feminax Ultra was licensed for short-term management of period pain and menstrual cramps in women aged 15-50. . A clinical trial with Flexiseq in 1300+ patients demonstrated a response in terms of pain, stiffness, and joint function.

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Ep. 003 – Ritesh Patel Podcast Transcript

Pharma Marketing Network

JUNE 10, 2020

Those things have always stayed in the licensing side of the business, that business that either went and acquired a molecule or licensed to molecule. or change the way I do clinical trials or change the way I actually do clinical recruitment? Now to get somebody into a clinical trial.

Marketing

Marketing Clinical Trials Clinical Trials Nurses

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

The Pharma Data

DECEMBER 29, 2020

NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Evaluation of its safety and efficacy is ongoing in multiple clinical trials. In the U.S.

Antibody

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Three pillars of post-pandemic launch excellence

pharmaphorum

APRIL 16, 2021

Longer term challenges, such as the slowdown of HTA outputs, delays to clinical trials and regulatory submission, and the coming impact of economic crisis on medicines budgets will further challenge launch prognosis in the coming years. Once approved, launches do not necessarily become immediately commercially available. “For

Sales

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Best Toenail Fungus Treatment Products

Druggist

OCTOBER 21, 2020

It is recommended that a particular group of people; for example, diabetic patients seek advice from a podiatrist or diabetic nurse as any infections in diabetes may lead to complications. Additionally, oral antifungal tablets are not licensed for use in children. rubrum (a common pathogen to cause fungal nail infection).

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Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

DECEMBER 13, 2022

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Drugs

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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.

Antibody

Antibody Production Manufacturing Clinical Trials

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

Data from the Phase 1/2/3 clinical trial supported an Emergency Use Authorization for casirivimab and imdevimab administered together, granted by the U.S. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

Antibody

Antibody Medicine Production Trials

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

DECEMBER 20, 2022

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Drugs

Drugs Licensing Licensing Containment

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

Pfizer

NOVEMBER 23, 2022

Voluntary Licensing : Signed a voluntary license agreement with Medicines Patent Pool (MPP) to enable the development and distribution of generic versions of Pfizer’s oral treatment to further expand long-term global supply and access. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Licensing

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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 20, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

Antibody

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

The Pharma Data

NOVEMBER 21, 2020

We are encouraged that no variants resistant to the cocktail were identified in the clinical trial analyses to date, which is consistent with our preclinical findings. The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process.

Antibody

Antibody Production Clinical Trials Clinical Trials

Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. The drug was licensed from Immutep Limited.

Trials

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New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups.

Antibody

Antibody Trials Clinical Trials Clinical Trials

Unblock My Hormones And Start Burning Fat TODAY With HB5

The Pharma Data

MAY 13, 2021

I could hear doctors and nurses speaking in hushed tones…. And Mary-Anne, a nurse from Arkansas, who says…. In a major double-blind clinical trial published in the American College of Endocrinology…. And I was rushed to hospital in the back of an ambulance… As paramedics desperately tried to keep me alive.

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Clinical Research Informer

Integrate RBQM Into Each Phase of the Clinical Trial “House”

Key Items Auditors Look for When Reviewing an Investigator Site File

Trending Sources

OncoHealth Expands Its Iris Platform for Digital Cancer Care

NICE backs Astellas’ oral therapy Evrenzo for anaemia in kidney disease

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

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

EISAI PUBLISHES SOCIETAL VALUE OF LECANEMAB USING PHASE 3 CLARITY AD DATA IN PEER-REVIEWED NEUROLOGY AND THERAPY JOURNAL

Ep. 003 – Ritesh Patel Podcast Transcript

18 products ALTERNATIVE to PARACETAMOL

Ep. 003 – Ritesh Patel Podcast Transcript

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

Three pillars of post-pandemic launch excellence

Best Toenail Fungus Treatment Products

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

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

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

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer Signs Agreement to Provide the European Union with PAXLOVID™

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

Clinical Catch-Up: January 18-22 | BioSpace

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Unblock My Hormones And Start Burning Fat TODAY With HB5

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