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  • NIH says Fourth Iteration of COVID-19 Treatment Trial underway

    NIH says Fourth Iteration of COVID-19 Treatment Trial underway

    National Institutes of Health says Fourth Iteration of COVID-19 Treatment Trial underway| site |


    (Information contained in National Institutes of Health [NIH] press release: November 25, 2020) The National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health, today announced that the fourth iteration of the Adaptive COVID-19 Treatment Trial (ACTT-4) has begun to enroll hospitalized adults with coronavirus disease 2019 (COVID-19) who require supplemental oxygen. The NIAID-sponsored trial will enroll up to 1,500 patients at approximately 100 sites in the United States and other countries. Participants will be assigned at random to one of two treatment arms of equal size. One group will receive both dexamethasone, a corticosteroid available as a generic drug, and remdesivir, a broad-spectrum antiviral discovered and developed by Gilead Sciences, Inc., of Foster City, California. Remdesivir, also known as Veklury, was r...
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  • NIH says Commonly used Antibiotic shows Promise for Combating Zika Infections

    NIH says Commonly used Antibiotic shows Promise for Combating Zika Infections

    National Institutes of Health says Commonly used Antibiotic shows Promise for Combating Zika Infections | site |


    NIH preclinical study suggests FDA-approved tetracycline-based antibiotics may slow infection and reduce neurological problems.


    (Information contained in National Institutes of Health [NIH] press release: November 24, 2020)

    In 2015, hundreds of children were born with brain deformities resulting from a global outbreak of Zika virus infections. Recently, National Institutes of Health researchers used a variety of advanced drug screening techniques to test out more than 10,000 compounds in search of a cure. To their surprise, they found that the widely used antibiotic methacycline was effective at preventing brain infections and reducing neurological problems associated with the virus in mice. In addition, they found that drugs originally designed to combat Alzheimer’s disease and inflammation may also help fight infections. ...
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  • American Hospital Association Statement on Most Favored Nation Model Interim Final Rule

    American Hospital Association Statement on Most Favored Nation Model Interim Final Rule | site |


    (Information contained in American Hospital Association [AHA] press release: November 20, 2020)



    AHA Statement on Most Favored Nation Model Interim Final Rule


    Tom Nickels
    Executive Vice President
    American Hospital Association


    November 20, 2020


    America’s hospitals and health systems have very deep concerns about the substance and legality of today’s Most Favored Nation Model interim final rule. Instead of holding drug companies accountable for drug prices, it slashes reimbursement to hospitals for drugs. In addition to the continued concerns we have expressed about the impact this model has on the 340B drug pricing program, we strongly question whether attempting to institute such a sweeping and controversial policy in an interim final rule is legally permissible. B...
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  • FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

    FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

    U.S. Food and Drug Administration Expands Approval of Influenza Treatment to Post-Exposure Prevention | site |


    (Information contained in U.S. Food and Drug Administration press release: November 23, 2020)

    Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra
    ...
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  • HHS Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19

    U.S. Department of Health and Human Services Allocates Regeneron Therapeutic to Treat Patients With Mild to Moderate COVID-19 | site |


    (Information contained in U.S. Department of Health and Human Services press release: November 23, 2020)

    The U.S. Department of Health and Human Services today announced plans to allocate initial doses of Regeneron’s investigational monoclonal antibody therapeutic, casirivimab and imdevimab, which received emergency use authorization from the U.S. Food and Drug Administration on November 21, 2020, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization.

    In July, the federal government announced federal funding to support large-scale manufacturing of casirivimab and imdevimab with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses to state and territorial health
    ...
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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

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


    (Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di
    ...
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  • Coronavirus COVID-19 Update - - - FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

    Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: November 20, 2020)

    The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

    “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and
    ...
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  • Statement from HHS Chief of Staff Brian Harrison on Unapproved Drugs Initiative

    Statement from HHS Chief of Staff Brian Harrison on Unapproved Drugs Initiative

    Statement from U.S. Department of Health and Human Services Chief of Staff Brian Harrison on Unapproved Drugs Initiative | site |


    (Information contained in U.S. Department of Health and Human Services press release: November 20, 2020)


    Statement from HHS Chief of Staff Brian Harrison on Unapproved Drugs Initiative

    Today, the Department of Health and Human Services (HHS) through a Notice published in the Federal Register announced the withdrawal of guidance documents issued as part of the Unapproved Drugs Initiative. HHS Chief of Staff Brian Harrison issued the following statement:

    “We are committed to putting American patients first by ending government programs like the Unapproved Drugs Initiative that, while well-intentioned, have distorted markets and produced the unintended consequences of price spikes and drug shortages.” – HHS Chief of Staff Brian Harrison

    Read the Frequently Asked Questions Regarding
    ...
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  • CMS Announces Historic Changes to Physician Self-Referral Regulations

    CMS Announces Historic Changes to Physician Self-Referral Regulations

    Centers for Medicare & Medicaid Services Announces Historic Changes to Physician Self-Referral Regulations| site |



    (Information contained in Centers for Medicare & Medicaid Services press release: November 20, 2020) Today, the Centers for Medicare & Medicaid Services (CMS) finalized changes to outdated federal regulations that have burdened health care providers with added administrative costs and impeded the health care system’s move toward value-based reimbursement. The Physician Self-Referral Law, also known as the “Stark Law,” generally prohibits a physician from making referrals to an entity for certain healthcare services, if the physician has a financial relationship with the entity. The old federal regulations that interpret and implement this law were designed for a health care system that reimburses providers on a fee-for-service basis, where the financial incentives are to deliver more services. However, the 21st century American health care...
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  • Coronavirus COVID-19 Update - - - FDA Authorizes Drug Combination for Treatment of COVID-19

    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |



    (Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)


    November 19, 2020


    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...
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