Manufacturing Updates in Brief
This article was originally published in The Gold Sheet
GMP issues delayed Boehringer launch; Nigerian firms meet WHO GMPs; Novartis closing Puerto Rico plant; Hospira closing Clayton site; Valeant looks to move Bausch + Lomb manufacturing abroad; these IV bags were training aides.
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Sponsor’s claimed impact on exercise tolerance was not adequately supported and should not serve as a marketing advantage for the chronic obstructive pulmonary disease drug, FDA review staff said. However, Boehringer Ingelheim’s failed attempt for the exercise-related labeling language spurred the agency to clarify the types of studies and endpoints that potentially could support such claims.
Genfit will delay unblinding of data from its nearly complete Phase III study of elafibranor to get insight from the FDA on statistical methods in order to optimize its NDA.