Drugs and Treatments Deemed to Offer Societal Benefit Could See Faster FDA Pathway
October 18 2012 - 7:20AM
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 Celsion Corporation (NASDAQ: CLSN) and Aastrom
Biosciences, Inc. (NASDAQ: ASTM).
Access to the full company reports can be found at:
www.ParagonReport.com/CLSN
www.ParagonReport.com/ASTM
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."
Paragon Report releases regular market updates on the Biotech
Industry so investors can stay ahead of the crowd and make the best
investment decisions to maximize their returns. Take a few minutes
to register with us free at www.ParagonReport.com and get exclusive
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Celsion is a late-stage biopharmaceutical company dedicated to
the development of innovative, targeted therapies that address
unmet medical needs in oncology. By applying their unique
heat-activated liposomal drug delivery system to proven anti-cancer
agents, they can deliver high concentrations of chemotherapeutics
directly to the tumor site.
Aastrom Biosciences is dedicated to the development of stem cell
treatments for critical cardiovascular diseases. Aastrom is
currently evaluating its autologous cellular therapies in
late-stage U.S. clinical trials in the treatment of critical limb
ischemia (CLI) and dilated cardiomyopathy (DCM). The company
recently reported that their President and CEO Tim M. Mayleben
plans to retire.
The Paragon Report 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
disclaimer at: http://www.paragonreport.com/disclaimer
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