Tag Archives: Food and Drug Administration

New PhRMA report: Nearly 800 Cancer Medicines in Development

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A new report from the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that biopharma companies are currently developing nearly 800 new medicines and vaccines for cancer. “In recent decades, we have seen great progress in developing effective cancer treatments that help extend lives, improve quality of life and increase productivity,” said PhRMA President and CEO John J. Castellani. “Continued research has expanded our knowledge of how cancer develops and how to target medicines for Read More >

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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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