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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 new brief submitted to the Supreme Court in which Amgen Inc. argued the Zarxio biosimilar lawsuit is a "poor vehicle" for interpreting the Biologics Price Competition and Innovation Act, and therefore, Sandoz Inc.'s petition to hear the case should be denied; another eye-opener involving Valeant Pharmaceutical International Inc.'s pricing practices, which this time involved Seconal, a drug used off-label in physician-assisted suicides; a decision by the Patent Trial and Appeal Board of the US Patent & Trademark Office to institute an inter partes review petition from hedge fund manager Kyle Bass challenging a patent held by Biogen Inc. on its 480mg dose of its multiple sclerosis drug Tecfidera (dimethyl fumarate); and the FDA's approval of Pine Brook, NJ-based Elusys Therapeutics Inc.'s Anthim (obiltoxaximab) in combination with appropriate antibacterial drugs to treat inhalational anthrax and prevent the disease when alternative therapies are not available or are not appropriate; plus other Washington news.






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