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The Challenge of Defining HIV Remission

Supportive regulatory guidance for cure research requires a clear understanding of all possible outcomes, including remission By Richard Jefferys The term remission is increasingly being invoked in the context of cure research and, by extension, is an issue for regulatory…

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PrEP: The Pathway to Global Access

Regulatory filing and review delays keep Truvada as pre-exposure prophylaxis out of reach of those who need it most By Scott Morgan Pre-exposure prophylaxis (PrEP) is the use of antiretroviral medication to prevent HIV acquisition. The U.S. Food and Drug…

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TAGline Fall 2015

In Defense of Stringency: In response to growing public concern with health risks posed by approved drugs, a 2006 landmark report by the Institute of Medicine (IOM) argued that the U.S. Food and Drug Administration (FDA) lacks the unambiguous authority necessary to ensure the safety and efficacy of the country’s medicinal products.
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TB R&D’s Shift to the Left

As the Bill & Melinda Gates Foundation realigns its TB vaccine strategy to focus on early-stage candidate development, equitable access priorities must also be established before large-scale trials are conducted By Mike Frick The Bill & Melinda Gates Foundation has…

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C U L8ter: Hepatitis C Eradication

Hepatitis C is now curable. Now all we need is surveillance to monitor it, global funding to fight it, and targets set to address it By Tracy Swan The first global targets for eliminating hepatitis C virus (HCV) will be…

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Toward an Ambitious National HIV/AIDS Strategy

We won’t end HIV as an epidemic with anemic goals, delayed surveillance data, feeble support of state policies and resource needs, and an inadequate implementation science agenda By Kenyon Farrow The U.S. National HIV/AIDS Strategy (NHAS) ends its five-year run…

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On Targets and Timelines

By Tim Horn With growing recognition that science and discovery have forged the tools necessary to effectively diagnose, treat, and, indeed, eliminate three of the world’s most lethal infectious diseases—HIV/AIDS, tuberculosis, and hepatitis C—there is a need for greater mobilization…

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