Tag Archives: Food and Drug Administration

Tekmira Pharmaceuticals Ebola Drug Gets Nod From FDA

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The U.S. Food and Drug Administration has authorized Canada’s Tekmira Pharmaceuticals to provide an experimental drug to people with confirmed or suspected Ebola virus infections, according to an article in The Wall Street Journal. “Our TKM-Ebola drug supplies are limited, but we will continue to help where we can,” Tekmira Chief Executive Mark J. Murray said in a press release. The drug is still in clinical testing to assess whether it is safe and effective. BIO Read More >

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Chicago Tribune Makes a Case for GMOs

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The editorial board of the Chicago Tribune recently wrote a great piece arguing why this state-by-state push for mandatory labeling of genetically modified food would do more to “frighten people than to inform them.” Editorial: The case for genetically modified food “Vermont recently joined two other New England states and passed a law to require labels on food that contains genetically modifed ingredients. Similar labeling laws have been proposed in two dozen other states, including Illinois. Read More >

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U.S. Rep. Charlie Dent Discusses PDUFA and NIH Funding at #BIOCEO14

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During the 16th Annual BIO CEO & Investor Conference, U.S. Representative Charlie Dent of Pennsylvania, co- chair of the Congressional Biomedical Research Caucus, joined BIO’s Fritz Bittenbender to discuss the biotech industry in Pennsylvania as well as recent legislative developments affecting the industry. Dent points to the recent omnibus spending agreement which allowed the Food and Drug Administration (FDA) to access user $85 million in user fees sequestered in 2013. These fees are paid to Read More >

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National Traceability System Moves into Implementation

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Last week, President Obama signed into law the Drug Quality and Security Act (H.R. 3204), which created a single, uniform and national solution to safeguard the nation’s pharmaceutical supply chain against criminal counterfeiting. Inside Health Policy’s Alaina Busch highlighted implementation plans in this November 20 story, “Drug Security Bill Ushers In Compounder Market Shift, 10-Year Effort To Implement Rx Tracing,” which can be accessed here with a subscription. Below are details on implementation based on Read More >

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Legislative Hopes, Fears

PNNL Research Scientist Heather Brown

Biotechnology advances are poised now more than ever to help policymakers achieve their goals of supporting innovation in health care, renewable energy, and green technologies. How can they help us? Here are our six hopes (and one big concern) for the term ahead. HOPE 1: Cultivate an atmosphere for patient access to our products While the Congress considers finding savings, do it in a way that does not threaten patient access to drug products by Read More >

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