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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 the return to Earth of US astronaut Scott Kelly, who had on board with him on the International Space Station hundreds of biomedical experiments, including those from drug makers, which got a free ride to space thanks to American taxpayers; a new lawsuit from Amgen Inc. and Roche AG accusing Novartis AG unit Sandoz Inc. of trying to "reap the commercial benefits" provided to biosimilar manufacturers under the Biologics Price Competition and Innovation Act, while seeking to avoid the obligations Congress established under the 2010 law "to protect innovators" and "piggybacking on the fruits" of the brand-name firms' "trailblazing efforts;" the revelation by Valeant Pharmaceuticals International Inc. that the Securities and Exchange Commission had opened a new investigation and issued a subpoena to the company, which is believed to be related to the firm's previous relationship with Philidor Rx Services Inc.; and an admission by Robert Califf, the new commissioner of the FDA, that if the agency doesn't get its pending biosimilars guidances out soon, "it's going to be difficult for people to navigate and know what they need to do;" plus other Washington news.

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