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 new rules unveiled by the US Treasury Department intended to curb the practice of corporate inversion, which ended up killing a deal under which Pfizer Inc. was planning to merge with Allergan PLC in a scheme to significantly lower the taxes New York drug giant was seeking to lower its tax rate; the FDA's approval of Celltrion Inc.'s and Pfizer Inc.'s Inflectra (infliximab-dyyb), the first monoclonal antibody biosimilar licensed in the US and only the second biosimilar approved by the agency; the oral arguments at the US Court of Appeals for the Federal Circuit in Amgen Inc.'s battle against Apotex Inc. over whether Congress intended for it to be mandatory for biosimilar makers to provide 180 days notice of commercial marketing to the reference product sponsor after the FDA licenses a copycat, even when the firms have engaged in the so-called patent dance under the Biologics Price Competition and Innovation Act; the adoption by the Senate Health, Education, Labor and Pensions' a set of 19 bills aimed at improving the efficiency and pace at which the FDA and the National Institutes of Health do their work; and the Obama administration's plan to redirect more than $500m of existing Ebola funds to Zika Virus research and development and preparation activities in light of Congress' failure to act on President Barack Obama's $1.9bn emergency supplemental request; plus other Washington news.
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