FDA's request for manufacturing data to delay Protalix's Uplyso
03 February 2010
Asher Mullard
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03 February 2010
Asher Mullard
asher.mullard@informa.com
The US FDA has requested additional chemistry, manufacturing and controls (CMC) data for Protalix/ Pfizer's Uplyso (taliglucerase alfa), delaying the review of the Gaucher's disease therapy.
No additional clinical or preclinical trials have been requested, Protalixemphasised. "The request...
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