FDA Considering Faster Pathway for Treatments of Deadly or Debilitating Diseases
October 17 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 Neuralstem, Inc. (NYSE: CUR) and AEterna Zentaris Inc.
(NASDAQ: AEZS).
Access to the full company reports can be found at:
www.ParagonReport.com/CUR
www.ParagonReport.com/AEZS
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.
Neuralstem's patented technology enables the ability to produce
neural stem cells of the human brain and spinal cord in commercial
quantities, and the ability to control the differentiation of these
cells constitutively into mature, physiologically relevant human
neurons and glia. Shares of the company surged over 8 percent
Monday after reporting positive results for their NSI-566 spiral
cord cells.
Aeterna Zentaris is an oncology and endocrinology drug
development company currently investigating treatments for various
unmet medical needs. The Company's pipeline encompasses compounds
at all stages of development, from drug discovery through to
marketed products. Aeterna recent reported that it expects to file
a New Drug Application early next year, for its oral ghrelin
agonist, AEZS-130.
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
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Aeterna Zentaris (NASDAQ:AEZS)
Historical Stock Chart
From Jul 2023 to Jul 2024