Tag Archives: FDA

Regeneron REGN-COV2 monoclonal antibody reported better in (non-hospitalized) patients who lack their own antibodies to SARS-CoV-2

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By Daniel R. Lucey M.D., MPH, FIDSA In assessing any potential benefit on symptom duration or viral load reduction, let alone “cure,” it is important to know whether non-hospitalized patients are already making their own antibodies against SARS-CoV-2 at the time they receive the Regeneron ”REGN-COV2 cocktail” of two monoclonal antibodies against the spike protein […]

Science, not politics, must lead to COVID vaccine approvals

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Political pressure to speed the introduction of COVID vaccines threatens scientifically proven systems to protect public safety and research integrity The following is a guest post from Uché Blackstock, MD, Founder & CEO, Advancing Health Equity, and Mitchell Warren, Executive Director, AVAC COVID-19 has devastated communities and health systems around the world – but it […]

COVID-19: FDA Emergency Use Authorization for a vaccine in the fall of 2020 means the time for public dialogue is August      

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By Daniel R. Lucey M.D., MPH, FIDSA The only past U.S. Food and Drug Administration Emergency Use Authorization for any vaccine was in January 2005 for the licensed (since 1970) anthrax vaccine to be used in military personnel “for prevention of inhalation anthrax for individuals between 18 and 65 years of age who are deemed […]

Study highlights “missed opportunities” to prevent HIV infections with PrEP

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In the three years following the U.S. Food and Drug Administration’s approval of a daily oral antiretroviral medicine to prevent HIV infection, records show that 885 South Carolina residents older than 13 were diagnosed with HIV. About two-thirds of them had visited health care facilities before their diagnoses — for a combined total of more […]

FDA TB drug approval a milestone, with caveats

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The U.S. Food and Drug Administration’s approval of the first new drug to treat tuberculosis in nearly half a century and the agency’s first use of its accelerated approval process to speed availability of TB medicine comes with cautions, and with a direction of work yet to be done, agency officials and treatment advocates agree. […]

FDA panel finds new type of TB drug effective, raising hopes for treatment of drug-resistant strains

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Dr. Dalene von Delft had a choice between dying  or going deaf, and that was a choice only if the arduous treatment she was undergoing for drug-resistant tuberculosis worked. The South African pediatrician had contracted a resistant strain of the disease caring for patients, and the only potentially effective treatment was showing one of its […]

Guns — or medicine? A doctor’s call, survey responses, and more in a presidential campaign edition of what we’re reading

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A doctor’s call for healthy foreign policy debate: John May, a South Florida corrections physician and founder of Health through Walls, a nonprofit that brings medical system support to prisons in developing countries, wrote this op-ed piece for the local newspaper in the county where the candidates were scheduled to hold their final debate on […]

Drug maker seeks approval for use against multidrug-resistant tuberculosis

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Makers of an investigational tuberculosis drug that has been urged for “compassionate use” approval in South Africa have applied to the European Medicines Agency to market the medicine as part of a combination therapy for multidrug-resistant tuberculosis. “If approved, bedaquiline could be one of the first drugs with a new mechanism of action for tuberculosis […]

Public and Private Sector Partners Help to Jump Start Development of New TB Drug Combinations

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This post is by Global Center Director Christine Lubinski. The excitement in the room was palatable today as FDA Commissioner Margaret Hamburg joined representatives from the Global Alliance for TB Drug Development, the Bill & Melinda Gates Foundation, the Treatment Action Campaign, and representatives from the pharmaceutical industry to announce a new collaboration to accelerate […]

100th Antiretroviral Drug approved by FDA for PEPFAR

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Federal officials today celebrated the approval of the 100th antiretroviral drug authorized under an expedited regulatory framework created five years ago, as a way to fast-track the delivery of cheap HIV drugs to the developing world through the PEPFAR program. A panel discussion, held at the Pan American Health Organization Headquarters to mark the milestone, […]