FDA advisory committees will weigh concerns that Endo’s reformulated version of oxymorphone extended-release, which does not contain abuse-deterrent labeling, has shifted preferred non-oral route of abuse from intranasal to intravenous, which carries additional safety risks.

CDER schedules an NDAC and DSRMAC joint meeting while also negotiating with industry stakeholders on a potential proposal for a user fee program to support FDA’s work on finalizing monographs or amending monographs with additional ingredients or indications.

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.