FDA Considering Faster Approval Process for Developers of Drugs for Deadly or Debilitating Diseases
The Paragon Report Provides Stock Research on Amgen and Celgene
(firmenpresse) - NEW YORK, NY -- (Marketwire) -- 11/05/12 -- 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 Amgen, Inc. (NASDAQ: AMGN) and Celgene Corporation (NASDAQ: CELG).
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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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Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. The company reported that revenues in the third quarter of 2012 surged 10 percent to $4.3 billion, which was driven by an 8 percent growth in product sales.
Celgene is focused on the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. The FDA last month approved ABRAXANE for the first-line treatment of advanced non-small cell lung cancer. The company forecasts 2012 EPS to increase approximately 29 percent year-over-year.
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:
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Datum: 05.11.2012 - 13:20 Uhr
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