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  • NIH says Investigational COVID-19 Therapeutics to be Evaluated in large Clinical Trials

    National Institutes of Health says Investigational COVID-19 Therapeutics to be Evaluated in large Clinical Trials | site |


    NIH trial enrolling people hospitalized with COVID-19


    (Information contained in National Institutes of Health [NIH] press release: December 17, 2020) Two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with moderate COVID-19. The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. One sub-study is evaluating VIR-7831, a monoclonal antibody developed through a partnership between GlaxoSmithKline plc (Brentford, United Kingdom) and Vir Biotechnology, Inc. (San Francisco). T...
    See more | Go to post

  • FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

    U.S. Food and Drug Administration Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development | site |




    (November 9, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:


    November 09, 2020

    Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations. We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, a
    ...
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  • NIH Study aims to Identify promising COVID-19 Treatments for larger Clinical Trials

    National Institutes of Health Study aims to Identify promising COVID-19 Treatments for larger Clinical Trials | site |



    (October 13, 2020) - - Today, the National Institutes of Health published the following information:

    The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show




    This scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. The virus shown was isolated from a patient in the U.S.
    Graphic courtesy NIAID

    promise against COVID-19 and merit...
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  • Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials

    Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials | site |



    (October 12, 2020) - - Today, October 12, 2020, Johnson & Johnson published the following information:



    Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials


    At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.

    We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines,
    ...
    See more | Go to post

  • NIH expands Clinical Trials to Test Convalescent Plasma against COVID-19

    National Institutes of Health expands Clinical Trials to Test Convalescent Plasma against COVID-19 | site |


    Rigorous studies to build on earlier efforts to test the experimental treatment


    (September 22, 2020) - - Today the National Institutes of Health published the following information: Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19. Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and
    ...
    See more | Go to post

  • U.S. Food and Drug Administration Awards 12 Grants to Fund New Clinical Trials to Advance the Development of Medical Products for the Treatment of Rare Diseases

    U.S. Food and Drug Administration Awards 12 Grants to Fund New Clinical Trials to Advance the Development of Medical Products for the Treatment of Rare Diseases



    (September 24, 2018) - - The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country. “Developing a treatment for a rare disease can be especially challenging. Given the often small number of patients affected by certain very rare diseases, there can be limited markets for new treatments, and as a result fewer resources devoted to researching these opportunities,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to doing it...
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  • Staff Reporter 1
    NIH says Investigational COVID-19 Therapeutics to be Evaluated in large Clinical Trials
    by Staff Reporter 1
    National Institutes of Health says Investigational COVID-19 Therapeutics to be Evaluated in large Clinical Trials | site |


    NIH trial enrolling people hospitalized with COVID-19


    (Information contained in National Institutes of Health [NIH] press release: December 17, 2020) Two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with moderate COVID-19. The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. One sub-study is evaluating VIR-7831, a monoclonal antibody developed through a partnership between GlaxoSmithKline plc (Brentford, United Kingdom) and Vir Biotechnology, Inc. (San Francisco). T...
    12-18-2020, 02:51 PM
  • Staff Reporter 1
    FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development
    by Staff Reporter 1
    U.S. Food and Drug Administration Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development | site |




    (November 9, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:


    November 09, 2020

    Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations. We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, a
    ...
    11-09-2020, 09:31 PM
  • Staff Reporter 1
    NIH Study aims to Identify promising COVID-19 Treatments for larger Clinical Trials
    by Staff Reporter 1
    National Institutes of Health Study aims to Identify promising COVID-19 Treatments for larger Clinical Trials | site |



    (October 13, 2020) - - Today, the National Institutes of Health published the following information:

    The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show




    This scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. The virus shown was isolated from a patient in the U.S.
    Graphic courtesy NIAID

    promise against COVID-19 and merit...
    10-13-2020, 11:24 PM
  • Staff Reporter 1
    Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials
    by Staff Reporter 1
    Announcement says Johnson & Johnson Temporarily Pauses All Dosing in their Janssen COVID-19 Vaccine Candidate Clinical Trials | site |



    (October 12, 2020) - - Today, October 12, 2020, Johnson & Johnson published the following information:



    Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials


    At Johnson & Johnson, there is no greater priority than the safety and well being of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles.

    We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines,
    ...
    10-13-2020, 10:47 PM
  • Staff Reporter 1
    NIH expands Clinical Trials to Test Convalescent Plasma against COVID-19
    by Staff Reporter 1
    National Institutes of Health expands Clinical Trials to Test Convalescent Plasma against COVID-19 | site |


    Rigorous studies to build on earlier efforts to test the experimental treatment


    (September 22, 2020) - - Today the National Institutes of Health published the following information: Two randomized, placebo-controlled clinical trials funded by the National Institutes of Health (NIH) are expanding enrollment to further evaluate convalescent plasma as a treatment for patients hospitalized with COVID-19. Preliminary observational studies indicate that convalescent plasma may improve outcomes among severely ill and hospitalized patients with COVID-19. Prospective, well-controlled randomized trials are needed to generate sufficient data on whether convalescent plasma is effective and safe for the treatment of COVID-19. Convalescent plasma is blood plasma taken from people who have recovered from COVID-19. It contains antibodies that can recognize and
    ...
    09-22-2020, 08:17 PM

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