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 unveiling at a White House summit of new actions and commitments from government agencies, including the National Institutes of Health and the FDA, and private-sector participants, including Pfizer Inc. and Roche AG unit Genentech Inc., aimed at speeding President Barack Obama's Precision Medicine Initiative forward; the US Senate's confirmation of Robert Califf as the new commissioner of the FDA; oral arguments at the US Supreme Court in a pair of consolidated lawsuits whose outcome could have broad implications for patent litigation and potentially change the way life sciences companies decide whether to launch a product at-risk; and the US Court of Appeals for the Federal Circuit setting April 4 to hear Apotex Inc.'s appeal in a lawsuit brought by Amgen Inc., which has been trying to delay the marketing of the biosimilars maker's version of Neulasta (pegfilgrastim); plus other Washington news