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Ironically, the agency encouraged Shire to enter the Fabry disease market in the US in the wake of protracted quality-control problems encountered by Genzyme.
FORBES: Shire Ends Fabry Drug Bid, Giving Sanofi A Boost
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Fabrazyme treats Fabry disease, which afflicts some 3, 000 patients worldwide.
FORBES: Magazine Article
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In a surprise move, Shire Pharmaceuticals has ended its bid for FDA approval for its Replagal biologic for treating Fabry disease, a rare, but life-threatening genetic disorder.
FORBES: Shire Ends Fabry Drug Bid, Giving Sanofi A Boost
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Last week, an Idaho woman has filed a lawsuit against Genzyme, charging that a long-standing shortage of its Fabrazyme treatment for Fabry disease led to the death of her husband two years ago.
FORBES: Shire Ends Fabry Drug Bid, Giving Sanofi A Boost