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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 assurance by the head of the National Institute of Allergy and Infectious Diseases that his scientists already are hard at work developing two vaccine candidates to prevent the Zika virus, with several biopharmaceutical companies already expressing interest in taking those products through to advanced development, although lawmakers insisted the effort had too slow of a start; questions raised over whether biosimilar makers may face failure-to-warn and design-defect liability claims, as well as lawsuits accusing the firms of making misleading or false advertising claims; a call by some US senators for the FDA to create an "express lane" to approve generics that would compete with single-source brand products whose prices have been substantially increased; and new holds placed on the confirmation of Robert Califf to be FDA commissioner; plus other Washington news.

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