Sharp Increase in FDA Drug Approvals a Major Factor in Biotech Industry's Success
RDInvesting Provides Stocks Research on NPS Pharmaceuticals and Oncothyreon
NEW YORK, NY -- (Marketwire) -- 02/18/13 -- 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 NPS Pharmaceuticals, Inc. (NASDAQ: NPSP) and Oncothyreon Inc. (NASDAQ: ONTY).
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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NPS Pharmaceuticals is focused on the development of orphan products for patients with rare gastrointestinal and endocrine disorders and high unmet medical needs. NPS clinical programs involve two therapeutic peptides to restore or replace biological function: Gattex (teduglutide), which was approved by the FDA in December, and Natpara.
Oncothyreon is a biotechnology company specializing in the development of innovative therapeutic products for the treatment of cancer. Oncothyreon's goal is to develop and commercialize novel synthetic vaccines and targeted small molecules that have the potential to improve the lives and outcomes of cancer patients. The company in December reported that L-BLP25 did not meet its primary endpoint in a pivotal Phase 3 clinical.
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