Regulatory Process an Ongoing Challenge for Speculative Biotech Firms
24 Février 2011 - 2:46PM
Marketwired
There is plenty of optimism surrounding the Biotech industry as
firmer pricing and new products have improved sales and earnings
trends. Meanwhile, younger, more speculative biotech firms continue
to garner significant attention with potential blockbuster drugs
working their way through the regulatory process. The Bedford
Report examines the outlook for companies in the Healthcare Sector
and provides research reports on Sunesis Pharmaceuticals, Inc.
(NASDAQ: SNSSD) and Orexigen Therapeutics, Inc. (NASDAQ: OREX).
Access to the full company reports can be found at:
www.bedfordreport.com/2011-02-SNSSD
www.bedfordreport.com/2011-02-OREX
A recent study released by BIO and BioMedTracker claims that the
success rate in bringing new medicines to market in the past six
years is only about half of what it had been previously. The study
claims, however, that biotech drugs are twice more likely to gain
approval than more traditional chemical drugs.
The study finds that drugs moving from early stage Phase I
clinical trials to FDA approval is roughly ten percent, down from
around 20 percent in reports involving earlier years.The report
adds that approval applications were filed for 55 percent of the
drugs that made it to Phase III testing, and 80 percent of those
gained eventual approval -- though only half were approved on
initial review.
The Bedford Report releases regular market updates on the
Healthcare Sector so investors can stay ahead of the crowd and make
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Obesity drugs have proven to be one of the most difficult to
gain approval. The FDA has proven to be very hesitant to approve
prospective obesity drugs due to both safety and efficiency
concerns. Earlier this month the FDA dealt Orexigen a blow when the
FDA declined to approve its obesity drug, Contrave, in the present
form and issued a complete response letter (CRL). The FDA stated
that it is concerned about the long-term cardiovascular safety
profile of the obesity candidate and has asked Orexigen to conduct
an additional study.
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