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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 petition to the US Supreme Court from Novartis AG unit Sandoz Inc. seeking to overturn an appeals court's ruling that a 180-day notice of commercial marketing for biosimilars is mandatory; an assertion by Apotex Inc. in new court documents that a preliminary injunction that prevents it from marketing a biosimilar of Neulasta (pegfilgrastim) for 180 days after the FDA licenses it is an "undisguised ploy" by Amgen Inc. to get an extra six months of "undeserved monopoly profits based on a crabbed reading" of the Biologics Price Competition and Innovation Act; reports by top international health officials that broad interest by industry has led to a rapidly evolving research and development landscape for a Zika virus vaccine; and new efforts by the FDA to more thoroughly examine how it regulates prescription opioids, which has been a hot button issue on Capitol Hill and at the heart of a handful of lawmakers' attempts to try to prevent Robert Califf from becoming the agency's new commissioner; plus other Washington news.

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