FDA Considering Allowing Developers of Critical Drugs/Treatments to Conduct Smaller, Faster Clinical Trials
November 02 2012 - 8:20AM
Marketwired
The Food and Drug Administration Commissioner Margaret Hamburg has
told scientific advisers that the FDA is considering a faster
pathway for obesity treatments, life-saving antibiotics and other
drugs deemed to offer societal benefit. The Paragon Report examines
investing opportunities in the Biotech Industry and provides equity
research on ImmunoGen, Inc. (NASDAQ: IMGN) and Orexigen
Therapeutics, Inc. (NASDAQ: OREX).
Access to the full company reports can be found at:
www.ParagonReport.com/IMGN www.ParagonReport.com/OREX
Under the new pathway the FDA would allow developers of such
drugs to conduct smaller, faster clinical trials, and provide a
"special medical use" label which would allow doctors to administer
drugs to patients with critical need. Hamburg has said that the FDA
needs to take into account the needs people with deadly or
debilitating diseases that may be willing to take on the risks of
unproven drugs.
"A pathway that would allow products to come to market faster
but would ensure they were used only in patients where there was an
applicable risk-benefit situation would be good," said Pew Health
Group's Allan Coukell, deputy director of medical programs. "It
would be good for developers, for companies and it would be good
for public health."
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ImmunoGen develops targeted anticancer therapeutics using
expertise in cancer biology, engineered antibodies and highly
potent cancer-cell killing agents. ImmunoGen's collaborative
partners include Amgen, Bayer HealthCare, Biotest, Lilly, Novartis,
Roche, and Sanofi. The company recently reported that marketing
applications have been submitted for trastuzumab emtansine (T-DM1)
in the U.S. and Europe.
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 is scheduled to release its third quarter 2012
results on November 7, 2012.
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