Six new breakthrough therapy designations have been announced, all for novel agents, but approvals were fewer and limited to new indications and formulations.

New approach that would eliminate the need for animal dosimetry data for some positron emission tomography drugs draws advisory committee support, although some panelists raise concerns about limited existing data and longer half-life for copper 64, one of the six radionuclides under consideration.

Private Company Edition: Third quarter venture capital funding for biopharmaceutical firms fell from Q2, but activity remains near all-time highs year-to-date. Several companies announced VC financings in early October, including Ascidian, which launched with $50m in series A financing.

Private Company Edition: While the tough state of financing for publicly traded drug developers continues, venture capital firms and private biopharma companies revealed billions of dollars in new VC funds and start-up financings, including $100m-plus mega-rounds for Tessa, Alladapt and ImCheck.