2013/2/1 - Biotechnology Industry Soars in 2012 as FDA Drug Approvals at a 15-Year High

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Bloomberg recently reported drug approvals by the U.S. Food and Drug Administration reached a 15 year high in 2012. The FDA approved a total of 39 novel medicines last year, an increase of 30 percent when compared to a year ago. Oncology drugs lead the way with 11 new drugs approved last year. Over the last ten years the number of FDA approvals had averaged roughly 23 a year. The passage of the Prescription Drug User Fee Act (PDUFA) played a major role in the sharp increase in approvals.

The PDUFA "has provided critical resources for improving the quality and timeliness of premarket review of drugs," said FDA spokeswoman, Sandy Walsh. "These accomplishments could not have been achieved without the innovations of the biopharmaceutical industry and the dedication and skill of FDA's drug review staff."

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Biosante Pharmaceuticals' portfolio of cancer vaccines includes four vaccines that have been granted Orphan Drug designation by the FDA. BioSante's other products include an FDA-approved testosterone gel for male hypogonadism. The company recently reported that it will hold will hold a special meeting of its stockholders on Friday, March 15th to discuss and vote on the proposed merger with ANI Pharmaceuticals, Inc.

Celsion is focused on advancing its heat-mediated, tumor-targeting drug delivery platform to address difficult-to-treat cancers. Celsion's HEAT study has been designated as a Priority Trial for liver cancer by the National Institutes of Health, received Fast Track Designation from the FDA and has received Orphan Drug Designation in both the U.S. and Europe.

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