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Test Your Knowledge of Antibiotics


Date added:
Nov 12, 2012

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The Super Bugs Causing Unmet Need and the Drugs to Fight Them

Issue Brief

Testing new antibiotics to treat highly resistant bacterial infections is especially difficult, since only a small number of patients contract such infections or meet the requirements to participate in clinical trials. Following are examples of hard-to-treat pathogens that present the greatest unmet needs today, and the types of drugs that are most likely to address them.

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Pew Testimony Before The President’s Council of Advisors on Science and Technology

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The President’s Council of Advisors on Science and Technology held a public meeting on April 4 to discuss the issue of antimicrobial resistance. Drug safety and innovation director Elizabeth Jungman testified on the need to spur the development of new antibacterial drugs.

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IDSA, Pew Support Regulatory Pathway for Antibiotic Development

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Today, Pew applauds increasing bipartisan support in Congress to spur antibiotic development and meet the needs of patients facing the growing threat of drug-resistant pathogens. More

Tracking the Pipeline of Antibiotics in Development

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Drug-resistant bacteria, or superbugs, present a serious and worsening threat to human health. According to a Centers for Disease Control and Prevention report, 2 million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and 23,000 of them die. Doctors routinely encounter patients with infections that do not respond to available treatment, and when new drugs come to market, bacteria quickly develop resistance. To ensure that the supply of new antibiotics keeps pace with these evolving pathogens, it is necessary to have a robust pipeline of new drugs and innovative pathways to get this medicine to the patients who need it the most

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From Lab Bench to Bedside: A Backgrounder on Drug Development

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The process of creating new medicines is complex, time-consuming, and costly. Moving a potential therapy from concept to market can take between 10 and 15 years and cost developers as much as $1 billion. Indeed, industry also bears the cost of failure: For every drug that ultimately receives approval from the U.S. Food and Drug Administration, some 5,000 to 10,000 compounds don’t make it through the process.

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Antibiotics Currently in Clinical Development

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As of February 2014, there are at least 45 new antibiotics with the potential to treat serious bacterial infections in clinical development for the U.S. market. The success rate for drug development is low; at best, only 1 in 5 candidates that enter human testing will be approved for patients. This snapshot of the antibiotic pipeline will be updated periodically as products advance or are known to drop out of development. More

Pew, 31 Other Organizations Send Letter of Support for the ADAPT Act

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The Pew Charitable Trusts sent a letter to Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) of qualified support of the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, a welcome step towards establishing a new regulatory pathway to bring desperately-needed antibiotics to the patients who need them most. The letter was also signed by 31 organizations representing healthcare providers, hospitals, pharmacists, clinical laboratory scientists and medical microbiologists, public health experts, patients and advocates. More

'ADAPT': A Regulatory Pathway to Develop Antibiotics and Fight Drug Resistant Infections

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On Dec. 12, 2013, a bipartisan bill was introduced in the U.S. House of Representatives to encourage development of antibiotics for patients with serious or life-threatening bacterial infections. The new legislation would direct the U.S. Food and Drug Administration, or FDA, to approve new antibiotics and antifungal drugs for specific, limited populations of patients who have infections for which few or no suitable options exist. More

To Take on Superbugs, Prime the Antibiotics Pipeline

Opinion

In the State of the Union address, President Barack Obama recognized the need to “stay ahead of drug-resistant bacteria” and that developing therapies to fight these threats is an opportunity for American innovation and discovery. The threat of drug-resistant bacteria is real, and the need for antibiotic development clear.

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Biocentury: Reps. Introduce Bill for Antibiotic Approval Pathway, Breakpoints

Media Coverage

A bipartisan group of representatives introduced in the U.S. House of Representatives a bill that would create an accelerated approval pathway for antibiotics and antifungals for use in limited populations and would update the criteria that HHS uses to determine breakpoints for drugs.

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Letter from Pew Thanking Representatives Gingrey and Green for Leadership on New Antibiotics Legislation

Issue Brief
Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) introduced legislation intended to bring antibiotics to patients with few other treatment options. In a letter, Pew called the bill, named the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, “a welcome step towards establishing a new regulatory pathway to bring desperately-needed antibiotics to the patients who need them the most.” More

Getting Smart is a Group Effort: Addressing the Crisis of Antibiotic Resistance

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More and more, we hear about drug-resistant bacteria—superbugs that few, if any, available therapies can kill. Recently, the Centers for Disease Control and Prevention, or CDC, released a report warning that infections from these pathogens result in at least 2 million illnesses and 23,000 deaths every year in the United States. More

GAIN: How a New Law is Stimulating the Development of Antibiotics

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On July 9, 2012, the Generating Antibiotic Incentives Now, or GAIN, provisions were signed into law by President Barack Obama as part of the Food and Drug Administration Safety and Innovation Act. This bipartisan legislation extends by five years the exclusivity period during which certain antibiotics—those that treat serious or life-threatening infections—can be sold without generic competition. This additional period of exclusivity increases the potential for profits from new antibiotics by giving innovative companies more time to recoup their investment costs.

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Washington Post: ‘Nightmare’ Bacteria are Real, and the U.S. Needs to Act Fast

Opinion

Last spring, Arjun Srinivasan, an associate director of the CDC, delivered a presentation to state health officials with some alarming information. Before the year 2000, he said, it was rare to find cases of bacteria resistant to carbapenems, a class of powerful, last-resort antibiotics. But by February 2013 they had been seen in almost every state. On March 5, Thomas Frieden, director of the CDC, issued a public warning about “nightmare” bacteria, a family of germs known as CREs. They can kill up to half the patients who get bloodstream infections from them, resist most or all antibiotics and spread resistance to other strains.

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The Lancet: Antibiotic Resistance: A Final Warning

Opinion

"On Sept 16, the US Centers for Disease Control and Prevention (CDC) released its report  Antibiotic Resistance Threats in the United States, 2013 —their first ever reporton this subject. From the outset the tone is clear: in his foreword, Tom Frieden, director of the CDC, states that "antimicrobial resistance is one of our most serious health threats. Infections from resistant bacteria are now too common." The stated aim of this report is to increase awareness of the threat resistance poses and to encourage immediat e action to address this threat."

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