SOURCE: Research Driven Investing

Research Driven Investing

February 08, 2013 08:20 ET

Sharp Increase in FDA Drug Approvals a Major Factor in Biotech Industry's Success

Research Driven Investing Provides Stocks Research on Amicus Therapeutics and Novavax

NEW YORK, NY--(Marketwire - Feb 8, 2013) - A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index (IBB), the SPDR S&P Biotech ETF (XBI) and the First Trust Amex Biotechnology Index ETF (FBT) have all gained over 20 percent in the past year, outperforming the broader markets by a good margin. Research Driven Investing examines investing opportunities in the Biotech Industry and provides equity research on Amicus Therapeutics, Inc. (NASDAQ: FOLD) and Novavax, Inc. (NASDAQ: NVAX).

Access to the full company reports can be found at:
www.RDInvesting.com/FOLD
www.RDInvesting.com/NVAX

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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Amicus Therapeutics has a robust pipeline of novel, first-in-class, small molecules called pharmacological chaperones for the treatment of lysosomal storage diseases (LSDs). These chaperones may offer a dual-treatment approach for Fabry, Pompe, Gaucher and other LSDs. During 2013, Amicus and GSK are committed to advancing migalastat HCl for Fabry disease.

Novavax is a clinical-stage biopharmaceutical company creating recombinant protein nanoparticle vaccines to address a broad range of infectious diseases. The company's recombinant nanoparticle protein micelle technology targeted at RSV has been tested in various preclinical studies and has now advanced into clinical testing.

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