Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.

Public Company Edition: UroGen raised $120m in a private placement of ordinary shares. Also, Verrica entered into a debt financing for up to $125m upon approval of Ycanth for molluscum contagiosum and job cuts were announced by Homology, Mersana, Infinity and others.

Vertex is closing in on annual revenues of $10bn from its cystic fibrosis drugs, but non-opioid pain therapy candidate VX-548 could open up a whole new blockbuster revenue stream if Phase III studies go to plan.

Although a new FDA guidance recommends difference in pain scores as the primary efficacy endpoint for evaluation of postoperative analgesic effect, data on outcomes such as reduction in hospitalization and deaths from opioid abuse would be valuable and could provide a basis for inclusion in labeling; guidance is part of broader agency effort to reduce opioid use.