Two recent industry developments-Genzyme's delay in gaining approval for its commercial-scale manufacturing of a new drug, and Amgen's announced layoffs-raise concerns about biotech performance at large scale. In the first case, the issue is manufacturing scale-up; in the second, it's how companies sustain long-term success once they become big. But in both cases, industry pundits are extrapolating conclusions from these issues that the facts don't seem to support.
As reported August 9 in The Wall Street Journal, Genzyme has been unable to get FDA approval for its large-scale production of Myozyme, a drug approved last year for Pompe's disease. According to the article, FDA says …
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