Regulatory environment helps small biotech

Small biotechs may be suffering on the economic front [1], but there is some good news for these companies. While the FDA is still cautious, a third of the novel drugs approved between 2005 and 2007 came from small biotech companies, according to the RPM Report. And that's a trend that's likely to continue. "With the passage of the FDA Amendments Act last year, the FDA now has a tool (Risk Evaluation and Mitigation Strategies, or REMS) that allows it more ways to say 'yes' to new drugs--by placing extra restrictions that limit the patient population that can access the product," reports RPM. That means that while the FDA may not be approving these drugs for a broad, billion-dollar market--the kind that Big Pharmas love--biotechs developing drugs for a more select group of patients will do well. Pursuing a REMS approval is by no means easy, but there's an opportunity here for biotechs targeting a smaller specialty market that most Big Pharma companies would ignore

- see the article [2] for more

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