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  • Centers for Medicare and Medicaid Services Increases Medicare Payment for COVID-19 Monoclonal Antibody Infusions

    Centers for Medicare and Medicaid Services Increases Medicare Payment for COVID-19 Monoclonal Antibody Infusions | site |


    New payment policy for at-home administration


    (Information contained in Centers for Medicare and Medicaid Services press release dated: May 6, 2021) As part of the ongoing response to address the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) has increased the Medicare payment rate for administering monoclonal antibodies to treat beneficiaries with COVID-19, continuing coverage under the Medicare Part B COVID-19 vaccine benefit. Beneficiaries pay nothing out of pocket, regardless of where the service is furnished – including in a physician’s office, healthcare facility or at home. Effective today, the national average payment rate will increase from $310 to $450 for most health care settings. In support of providers’ efforts to prevent the spread of COVID-19, CMS will also establish...
    See more | Go to post

  • FDA Coronavirus COVID-19 Update - - - FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



    FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: April 16, 2021)

    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential
    ...
    See more | Go to post

  • Clinical Trial in Hospitalized COVID-19 Patients evaluates long-acting Antibody Therapy

    Clinical Trial in Hospitalized COVID-19 Patients evaluates long-acting Antibody Therapy| site |


    NIH trial has begun enrolling participants.


    (Information contained in National Institutes of Health [NIH] press release dated: February 8, 2021) An international randomized, controlled Phase 3 clinical trial has begun evaluating the safety and efficacy of an investigational long-acting antibody combination for treating people hospitalized with COVID-19. The trial, part of a master protocol known as ACTIV-3, 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. The new sub-study is evaluating AZD7442, an investigational long-acting antibody combination developed by biopharmaceutical company AstraZeneca (Cambridge, United Kingdom). Antibodies are infection-fighting ...
    See more | Go to post

  • NIH says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19

    National Institutes of Health says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19 | site |



    (Information contained in National Institutes of Health [NIH] press release: January 5, 2021)

    A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for its safety and efficacy in people who have mild or moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

    NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates. ACTIV-2 is a master protocol
    ...
    See more | Go to post

  • CMS Takes Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment

    Centers for Medicare and Medicaid Services Takes Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment | site |


    (November 10 - 13, 2020) - - In a release dated November 10, 2020 and updated November 13, 2020, the Centers for Medicare and Medicaid Services (CMS) published the following information: The Centers for Medicare & Medicaid Services announced that starting today, Medicare beneficiaries can receive coverage of monoclonal antibodies to treat coronavirus disease 2019 (COVID-19) with no cost-sharing during the public health emergency (PHE). CMS’ coverage of monoclonal antibody infusions applies to bamlanivimab, which received an emergency use authorization (EUA) from the U.S. Food and Drug Administration yesterday. “Today, CMS is announcing a historic, first-of-its kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost sharing,” said CMS Administrator Seema Verma. “Our tim...
    See more | Go to post

  • Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

    Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Authorizes Monoclonal Antibody for Treatment of COVID-19 | site |



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

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivima
    ...
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  • U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests

    U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests| site |



    (May 21, 2020) - - The U.S. Food and Drug Administration (FDA) published today (May 21, 2020) the following information:

    Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on
    ...
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  • Staff Reporter 1
    Centers for Medicare and Medicaid Services Increases Medicare Payment for COVID-19 Monoclonal Antibody Infusions
    by Staff Reporter 1
    Centers for Medicare and Medicaid Services Increases Medicare Payment for COVID-19 Monoclonal Antibody Infusions | site |


    New payment policy for at-home administration


    (Information contained in Centers for Medicare and Medicaid Services press release dated: May 6, 2021) As part of the ongoing response to address the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) has increased the Medicare payment rate for administering monoclonal antibodies to treat beneficiaries with COVID-19, continuing coverage under the Medicare Part B COVID-19 vaccine benefit. Beneficiaries pay nothing out of pocket, regardless of where the service is furnished – including in a physician’s office, healthcare facility or at home. Effective today, the national average payment rate will increase from $310 to $450 for most health care settings. In support of providers’ efforts to prevent the spread of COVID-19, CMS will also establish...
    05-07-2021, 02:28 AM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



    FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: April 16, 2021)

    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential
    ...
    04-18-2021, 04:36 AM
  • Staff Reporter 1
    Clinical Trial in Hospitalized COVID-19 Patients evaluates long-acting Antibody Therapy
    by Staff Reporter 1
    Clinical Trial in Hospitalized COVID-19 Patients evaluates long-acting Antibody Therapy| site |


    NIH trial has begun enrolling participants.


    (Information contained in National Institutes of Health [NIH] press release dated: February 8, 2021) An international randomized, controlled Phase 3 clinical trial has begun evaluating the safety and efficacy of an investigational long-acting antibody combination for treating people hospitalized with COVID-19. The trial, part of a master protocol known as ACTIV-3, 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. The new sub-study is evaluating AZD7442, an investigational long-acting antibody combination developed by biopharmaceutical company AstraZeneca (Cambridge, United Kingdom). Antibodies are infection-fighting ...
    02-09-2021, 01:10 AM
  • Staff Reporter 1
    NIH says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19
    by Staff Reporter 1
    National Institutes of Health says Large Clinical Trial will Test Combination Monoclonal Antibody Therapy for mild/moderate COVID-19 | site |



    (Information contained in National Institutes of Health [NIH] press release: January 5, 2021)

    A Phase 2/3 clinical trial has begun to evaluate a combination investigational monoclonal antibody therapy for its safety and efficacy in people who have mild or moderate COVID-19. The two experimental antibodies, BRII-196 and BRII-198, target SARS-CoV-2, the virus that causes COVID-19. The trial, known as ACTIV-2, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

    NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program is a public-private partnership to develop a coordinated research strategy for speeding development of the most promising treatments and vaccine candidates. ACTIV-2 is a master protocol
    ...
    01-06-2021, 01:56 AM
  • Staff Reporter 1
    CMS Takes Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment
    by Staff Reporter 1
    Centers for Medicare and Medicaid Services Takes Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment | site |


    (November 10 - 13, 2020) - - In a release dated November 10, 2020 and updated November 13, 2020, the Centers for Medicare and Medicaid Services (CMS) published the following information: The Centers for Medicare & Medicaid Services announced that starting today, Medicare beneficiaries can receive coverage of monoclonal antibodies to treat coronavirus disease 2019 (COVID-19) with no cost-sharing during the public health emergency (PHE). CMS’ coverage of monoclonal antibody infusions applies to bamlanivimab, which received an emergency use authorization (EUA) from the U.S. Food and Drug Administration yesterday. “Today, CMS is announcing a historic, first-of-its kind policy that drastically expands access to COVID-19 monoclonal antibodies to beneficiaries without cost sharing,” said CMS Administrator Seema Verma. “Our tim...
    11-13-2020, 09:24 PM

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