McKesson’s exit from the space forced sponsors to switch vendors managing their REMS programs, which in some instances affected patient access to drugs. Omnibus legislation requires GAO report and collection of public input on factors FDA should consider in reviewing vendor changes.

SIGA provides an update on its monkeypox program, while Massive Bio announces progress on its AI platform for connecting cancer patients to trials, with additional updates from BridgeBio, the Oncology Institute, and CROs Caidya, Charles River Labs, Syneos Health and PPD parent Thermo Fisher Scientific.

In Scrip’s new column tracking clinical trial developments, NewAmsterdam, CatalYm, Verve, Bellerophon and Almirall announced new trials or changes to existing ones, while CROs Parexel and PPD announced new programs and CTI appointed a new exec.

Deals show large investors’ appetite for early-stage biotech, but can VC and PE rub along?