FDA Approved a Total of 39 New Drugs in 2012 -- Fifteen Year High
February 05 2013 - 8:20AM
Marketwired
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 Idenix Pharmaceuticals, Inc.
(NASDAQ: IDIX) and Orexigen Therapeutics, Inc. (NASDAQ: OREX).
Access to the full company reports can be found at:
www.RDInvesting.com/IDIX www.RDInvesting.com/OREX
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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Biotech Industry so investors can stay ahead of the crowd and make
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Idenix has focused its efforts towards HCV due to the global
unmet medical need for this viral disease. It is estimated that
more than 170 million people worldwide are chronically infected
with HCV. The company has previously discovered and developed
antivirals for the treatment of hepatitis B virus and HIV/AIDS. The
company has recently announced a non-exclusive collaboration with
Janssen Pharmaceuticals, Inc. for the clinical development of
all-oral direct-acting antiviral HCV combination therapies.
Orexigen Therapeutics is a biopharmaceutical company focused on
the treatment of obesity. The Company's lead product candidate is
Contrave, which has completed Phase III clinical trials and for
which a New Drug Application has been submitted and reviewed by the
FDA. The company earlier this month reported progress with the FDA
on a faster path to resubmission of the Contrave NDA.
Research Driven Investing 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
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