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Fast Track Drugs Come to Market in the U.S. with FDA Cooperation, Business and Industry Trends Analysis

Despite exponential advances in biopharmaceutical knowledge and technology, biotech companies enduring the task of getting new drugs to market continue to face long timeframes, daunting costs and immense risks.  By one count, of every 1,000 experimental drug compounds in some form of pre-clinical testing, only one makes it to clinical trials.  Then, only one in five of those drugs make it to market.  Of the drugs that get to market, only one in three bring in enough revenue to recover their costs.  Meanwhile, the patent expiration clock is ticking—soon enough, manufacturers of generic alternatives steal market share from the firms…

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