FDA Considering Faster Approval Process for Developers of Drugs for Deadly or Debilitating Diseases
November 01 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 ImmunoCellular Therapeutics Ltd. (NYSE: IMUC) and
Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX).
Access to the full company reports can be found at:
www.ParagonReport.com/IMUC www.ParagonReport.com/IDIX
Under the new pathway the FDA would allow developers of such
drugs to conduct smaller, faster clinical trial, 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
access to our numerous stock reports and industry newsletters.
ImmunoCellular's products and technologies are designed to
harness the power of the immune system to improve the treatment of
cancer. The company is developing active immunotherapies that
target not only regular tumor cells, but also the cancer stem cells
believed to cause cancer growth and recurrence. ImmunoCellular is
scheduled to release it third quarter financial results on November
14, 2012.
Idenix Pharmaceuticals is engaged in the discovery and
development of drugs for the treatment of human viral and other
infectious diseases. Idenix's current focus is on the treatment of
hepatitis C virus infections. The company has previously discovered
and developed antivirals for the treatment of hepatitis B virus and
HIV/AIDS.
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
Add to Digg Bookmark with del.icio.us Add to Newsvine
(MM) (NASDAQ:IDIX)
Historical Stock Chart
From Sep 2024 to Oct 2024
(MM) (NASDAQ:IDIX)
Historical Stock Chart
From Oct 2023 to Oct 2024