NEW YORK, NY--(Marketwire - Oct 23, 2012) - 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 PDL BioPharma Inc. (NASDAQ: PDLI) and Sequenom, Inc. (NASDAQ: SQNM).
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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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PDL BioPharma is a biotech company with a patented process to create humanized antibodies. PDL engages in the management of antibody humanization patents and royalty assets, which consist of its Queen et al. patents and license agreements with various biotechnology and pharmaceutical companies. The company earlier this month reported the completion of a royalty transaction with AxoGen, a regenerative medicine company.
Sequenom's proprietary MassARRAY system is a high-performance mass spectrometry based DNA analysis platform that efficiently and precisely measures the amount of genetic target material and variations. The company is scheduled to release their third quarter 2012 financial results on November 1, 2012.
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