FDA Considering Faster Pathway for Treatments of Deadly or Debilitating Diseases
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).
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."
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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
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