Improving Trend in FDA First Cycle Review Approvals a Major Factor for Biotech Industry's Success in 2012
November 20 2012 - 8:20AM
Marketwired
The Biotech Industry has skyrocketed in 2012 as an increase in the
number of new drug approvals has boosted investor optimism within
the industry. The iShares Nasdaq Biotechnology Index Fund (IBB) and
the SPDR S&P Biotech ETF (XBI) have both gained over 25 percent
year-to-date. Five Star Equities examines the outlook for companies
in the Biotech Industry and provides equity research on AEterna
Zentaris Inc. (NASDAQ: AEZS) and Keryx Biopharmaceuticals (NASDAQ:
KERX).
Access to the full company reports can be found at:
www.FiveStarEquities.com/AEZS
www.FiveStarEquities.com/KERX
"In 2011, the U.S. FDA approved 30 new drugs, compared to 21 in
2010," S&P Capital IQ wrote in a note. "Through September 2012,
the year-to-date total was 22. We see an improving trend for FDA
first cycle review approvals and a rise in the rate of new drug
approvals for rare diseases, which we think is helping to boost
investor sentiment for the agency, after years of criticism
stemming from inconsistency in making and communicating its
decisions."
Another key factor in the Biotech Industry's success has been
the "patent cliff" major pharmaceuticals have faced in 2012. Major
drug manufacturers have looked to biotech companies to help offset
major revenue losses from expiring patents as it is less time
consuming than developing new drugs through R&D.
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Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The company has recently announced the
initiation of the Phase 2 portion of its ongoing Phase 1/2 study in
castration- and taxane-resistant prostate cancer (CRPC) with
AEZS-108.
Keryx Biopharmaceuticals is focused on the acquisition,
development and commercialization of medically important
pharmaceutical products for the treatment of renal disease. The
company has recently announced the initiation of a Phase 2 study of
Zerenex for the treatment of patients with non-dialysis dependent
chronic kidney disease.
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