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US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

This article was originally published in Scrip

Executive Summary

This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included new insight into how President Barack Obama's nominee to lead the FDA, Robert Califf, would run the agency and additional questions raised ahead of his confirmation by the Republican and Democratic leaders of the Senate Health Committee; Apotex Inc.'s strategy for winning a lawsuit involving its pegfilgrastim biosimilar brought by Amgen Inc., plus how supporters of the former company think the US Court of Appeals for the Federal Circuit should rule in the case; and the move by Valeant Pharmaceuticals International Inc., which is under investigation by federal prosecutors and Capitol Hill lawmakers, to substitute Howard Schiller for ailing CEO Michael Pearson; plus other Washington news.