The FDA granted breakthrough device status to Prescient Metabiomics' Lifekit Prevent colorectal neoplasia test. Prescient Metabiomics is a subsidiary of Carlsbad, Calif.-based Prescient Medicine Holdings Inc.

Glaxosmithkline plc has won FDA approval to market Nucala (mepolizumab) for use in children as young as 6 with severe eosinophilic asthma (EA). The therapy already had FDA approval as an add-on maintenance treatment for kids with the same condition ages 12 and older. Approval of the sBLA, submitted last November, catches the U.S. market up to the EU, where Nucala has been approved as an add-on treatment for children ages 6 to 17 since August 2018.

Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).