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As multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.
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The Superbug Threat explores the emergence of antibiotic resistant bacteria and its impact on human health, as well as the shrinking pipeline of new antibiotics.
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The Generating Antibiotic Incentives Now (GAIN) Act of 2011 (H.R. 2182) seeks to create incentives to encourage the development of products to treat, prevent, detect and diagnose antibiotic-resistant infections. It extends the length of time an approved drug is free from competition and clarifies the regulatory pathway for new antibiotics.
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The lack of new antibiotics and the rise in drug resistance have rendered some serious and life-threatening infections untreatable, and the health care community is searching for ways to bring innovative new drugs to patients whose treatment options are limited or nonexistent.
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Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
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Hiking the Appalachian Trail, Steve Weisel thought little of the blisters on his feet until he discovered they were infected with life-threatening methicillin-resistant Staphylococcus aureus (MRSA) -- an increasingly common "superbug" that does not respond to first-line antibiotics. Mr. Weisel's story demonstrates the urgent need for new and innovative therapies to treat this growing threat.
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Staphylococcus aureus, or staph, is a common bacterium that exists in our environment and our bodies. Most of the time it does no harm. Sometimes, however, it can cause infection and require treatment. MRSA refers to strains of S. aureus that are resistant to the antibiotic methicillin and a host of other drugs used to treat infection.
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National and international headlines warn that multidrug-resistant superbugs are on the rise and the pipeline of new antibiotics is running dry.
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This year's celebration of National Public Health Week (NPHW) focuses on the theme, "Public Health is ROI: Save Lives, Save Money." Join us in recognizing the work of Pew's Health Initiatives.
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One of the most notorious multidrug-resistant superbugs, MRSA is responsible for an estimated 19,000 deaths and 360,000 hospitalizations each year in this country. Jamel’s story illustrates the twin dangers presented by emerging multidrug-resistant bacterial infections and the waning effectiveness and availability of drugs to treat them.
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On August 22, researchers at the National Institute of Health released a scientific paper detailing the use of advanced genetic technology to trace a deadly infection, untreatable by nearly every antibiotic, that spread through the NIH’s Clinical Center last year.
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Antibiotic-resistant infections are a growing public health threat. At the same time, antibiotic innovation is waning. Pew, the IIDSA and PhRMA hosted a one-day conference, Reviving the Pipeline of Life-Saving Antibiotics: Exploring Solutions to Spur Innovation on September 22, 2011, exploring ways to overcome the challenges that hinder the development of new antibiotics.
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Nearly nine in 10 Americans recognize that antibiotics are effective treatments for fighting bacterial infections like strep throat, but more than a third mistakenly believe the drugs are also appropriate treatments for viral infections such as the common cold. Test your antibiotics IQ and take the quiz.
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Allan Coukell, Director of Medical Programs, and Sharon Ladin, Director of the Antibiotics and Innovation Project, testify before the House Committee on Energy and Commerce, Subcommittee on Health on stimulating the development of new antibiotics urgently needed to fight serious and life-threatening bacterial infections.
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Since Operations Iraqi Freedom and Enduring Freedom began, many American servicemen and women have been infected with antibiotic-resistant bacteria. While our men and women in uniform increasingly survive severe wounds sustained in combat, their injuries leave them susceptible to life-threatening, hard-to-treat infections. Marine Lance Corporal Jonathan Gadsden’s story reflects the growing need for new antibiotics that can treat these dangerous diseases, against which most drugs are useless.
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