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Citizen-Petition Ploy Could Become New FDA Bugaboo

By Randall Osborne


Monday, August 22, 2005

Recalling biotechnology battles is almost like re-living boxing matches from the past.

Who could forget when Genzyme Corp. faced off against Transkaryotic Therapies Inc. to get first approval for a Fabry's disease therapy? In a hard-fought showdown, Genzyme had Fabrazyme (agalsidase beta) pitted against TKT's Replagal (agalsidase alfa). At the final bell, the loser was TKT, which gave up efforts to win FDA approval after gaining market clearance in 27 countries, and the FDA gave its nod to Genzyme's drug. Lights out.

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