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Biotech Industry Sees Gains After New FDA Legislation Signed Into Law

NEW YORK, NY--(Marketwire - Sep 25, 2012) - Despite concerns of a global economic slowdown the Biotech Industry has impressed investors with strong gains in 2012. Patent expirations, favorable legislation, and a faster review process have been some of the contributing factors for the industry's current boom. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Threshold Pharmaceuticals, Inc. ( NASDAQ : THLD ) and ISIS Pharmaceuticals, Inc. ( NASDAQ : ISIS ).

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The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 by President Obama. The law allows the FDA to collect "user fees" to help fund reviews of innovator drugs, medical devices, generic drugs and biosimilars.

"The legislation will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase the Food and Drug Administration's (FDA) access to external expertise to improve the drug review process," Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood said in a statement.

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Threshold is a biotechnology company focused on the discovery and development of drugs targeting Tumor Hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of some hematologic malignancies. This approach offers broad potential to treat a variety of cancers. Shares of the company fell sharply after reporting weak trial results for TH-302.

Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 25 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, and cancer. Isis' partner, Genzyme, plans to commercialize Isis' lead product, KYNAMRO, following regulatory approval. 

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: