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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 a warning to the biopharmaceutical industry by a US senator that the "pitchforks" are out over skyrocketing drug prices and that lawmakers are not done looking at the issue – declaring "something is going to happen;" a win by Amgen Inc. in a jury trial involving two patents on its proprotein convertase subtilisin/kexin 9 inhibitor Repatha (evolocumab) against Sanofi SA and Regeneron Pharmaceuticals Inc., which market a competing drug, Praluent (alirocumab , which stands to impact the profitability of both firms' products, which could impact the long-term value distribution of the class of medicines; a new policy instituted by the FDA to expedite the reviews for applications of generic versions of medicines that are the sole source on the market, which may have just changed the debate over the price hikes of those brand-name products; and a ruling by a three-judge panel from the US Court of Appeals for the Federal Circuit that generic drug makers can be sued for patent infringement in any US jurisdiction where those firms plan to compete; plus other Washington news.

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