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Putting Patients First: Paving a Path to Useful CER

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Comparative effectiveness research (CER) has the potential to improve health outcomes by helping people make better-informed decisions. But how do we know that CER will generate information that is useful? On September 30, in Washington, DC, you can be part of a conversation featuring a broad range of health care stakeholders—patients, providers, policymakers, payers, researchers, and those who fund research–by participating in an effort led by the National Health Council to create a framework to Read More >

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FDA Consumer Update: Advances in Saving Lives with Blood

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Every two seconds in the U.S., someone needs a blood transfusion or blood product—people of all ages who are injured, need surgery or who are suffering from illness. The Food and Drug Administration’s primary responsibility with regard to blood and blood products is to assure the safety of patients who receive these life-saving products. In this interview, Richard Davey, M.D., director of the Division of Blood Applications, Office of Blood Research and Review at FDA Read More >

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Exploring New Solutions For Neglected Diseases in Developing Countries

SBIR Reauthorization Moves Forward

On Tuesday, BIO Ventures for Global Health (BVGH) announced the completion of the 30th research agreement as part of its partnership with the World Intellectual Property Organization (WIPO) to better enable drug companies to assist researchers in addressing infectious diseases worldwide. The partnership aims to accelerate development of drugs, diagnostics and vaccines for more than 1.5 billion people suffering from malaria, tuberculosis, and other neglected tropical diseases including dengue in developing nations. A recent publication in Read More >

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CTTI: Use of Central IRBs in Multi-Center Trials to Streamline Clinical Research

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Multi-center clinical trials can provide high-quality, statistically-sound evidence to answer medical questions. Earlier this year, the Clinical Trials Transformation Initiative (CTTI) launched a new tool and provided recommendations to improve the efficiency and quality of multi-center clinical trials. Typically, each participating center submits the study protocol to its institutional review board (IRB). Thus in a multi-center trial, the same protocol is submitted to as many IRBs as there are sites. The process of multiple reviews Read More >

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New PhRMA Report: Nearly 300 Vaccines Currently in Development

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Today, the Pharmaceutical Research and Manufacturers of America released a report, Medicines in Development: Vaccines – A Report on the Prevention and Treatment of Disease Through Vaccines. The report shows that U.S. biopharma companies are currently developing 271 vaccines to prevent and treat numerous conditions, including infectious diseases and various forms of cancer and neurological disorders. Vaccines have successfully prevented devastating infectious diseases such as smallpox, measles and polio. According to data from the Centers Read More >

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