Tag Archives: FDA

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, […]

An Easier Path to New TB Tools?

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The search for new TB drugs and diagnostics is a long and windy road, paved with regulatory bumps and expensive R & D hurdles. But the path could get a little smoother under an amendment recently added to the Senate’s fiscal year 2010 funding bill for the Food and Drug Administration and other related programs. […]

FDA Panel Says Threat of MDR-TB Warrants Fast-Track for New Drugs

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A Food and Drug Administration advisory committee has decided that the threat posed by MDR-TB merits a fast-track approval process for potential new treatments. The clock is ticking, as drug-resistant TB spreads across the globe and scientists search for new drugs to combat this virulent germ. Given that background, the FDA’s Anti-Infective Drugs Advisory Committee […]