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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 declaration by the new head of the Pharmaceutical Research and Manufacturers of America that drug makers have played defense long enough in the debate over skyrocketing prices of medicines and it's time to go on the offense and drive the discussion; the start of US astronaut Scott Kelly's Earth-bound portion of tests in NASA's Twins Study after his return from his year on board the International Space Station; a plea by the acting head of the Centers for Medicare & Medicaid Services for biopharmaceutical firms to engage with the agency in figuring out if alternative payment designs that will be tested in a demonstration project will reduce expenditures for Medicare Part B, which covers prescription medicines that are administered in physician's offices or hospital outpatient department; and the filing by Amgen Inc. of another lawsuit against Novartis AG unit Sandoz Inc. accusing it of violating certain aspects of the Biologics Price Competition and Innovation Act patent-dispute-resolution provisions – commonly called the patent dance – with its biosimilar of pegfilgrastim, a product the innovator markets as Neulasta; plus other Washington news.






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