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

Executive Summary

This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included an assertion by the Biotechnology Innovation Organization that if the US Supreme Court permits the process for so-called inter partes reviews to remain on its current course, not only would patent claims held by innovator drug makers likely continue to be invalidated at unprecedented levels, but investment in the biopharmaceutical sector and partnering and acquisition deals among drug companies are at greater risk of falling apart; concerns raised by a panel of biopharmaceutical executives that their efforts for creating vaccines to address emerging infectious diseases may not pay off if there's no guarantee there will be a buyer for their products; an even harsher review in the FDA's revised documents of Sarepta Therapeutics Inc.'s data for its Duchenne muscular dystrophy eteplirsen than the evaluation revealed in January before a snowed-out advisory committee meeting was rescheduled; the release of a new report sponsored by Amgen Inc. that contends 2016 promises to bring greater clarity to the American landscape for the copycat biologics; the shutdown by the National Institutes of Health of two sterile production facilities, which stemmed from an ongoing investigation launched last spring; plus other Washington news.

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