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Latest From QOL Medical LLC

Genzyme’s Lumizyme REMS Eliminated Due To Expanded Indication

FDA approves Lumizyme for all Pompe disease patients, making it unnecessary to restrict use to a specific age group; Myozyme, produced at a different scale, will remain available.

BioPharmaceutical Regulation

REMS Modification Studies Could Use Foreign Markets As Controls

A look at the safety record of a drug in foreign countries where REMS elements are not in play could differentiate the impact of a REMS compared to other risk management efforts, Amgen suggests.

BioPharmaceutical North America

Avandia Re-Adjudication Might Result In “Refreshing” Restricted Distribution Roll Back

More than half of a 26-member advisory committee supports eliminating or easing the REMS for GSK’s diabetes drug, but the spilt vote and high-profile of the product’s safety issues suggest that FDA is unlikely to modify Avandia’s risk management.

BioPharmaceutical North America

FDA Drops Restricted Access Requirement For Amgen’s Nplate And GSK’s Promacta

FDA’s decision to modify the risk program for thrombocytopenia treatments may influence CMS to drop Nplate from its list of potential National Coverage Determinations.

BioPharmaceutical Post Market Regulation & Studies
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