Plus alliances involving Xyphos/Kelonia, Nippon Shinyaku/Vicor, Telix/QSAM, Nicox/Kowa, Kyowa Kirin/BridgeBio, as well as deals in brief.

The recent success of Vertex in acute pain merely highlights the agonizingly slow process elsewhere, particularly in chronic pain indications.

Without sponsors willing to work with them and in the absence of legislation giving FDA authority over lab-developed tests, the agency has launched internal programs to both gain more oversight – and spur innovation.

Commissioner says more judges have recently stepped in and ‘acted like they were FDA.’ Concern is heightened as Supreme Court is to rule on whether to overturn or limit Chevron deference to agency decisions.