AcelRx oversimplified Dsuvia’s ease of use, Office of Prescription Drug Promotion says. Focus on opioid safety comes as critics of Janet Woodcock have pointed to FDA’s decisions in the space as disqualifying her for FDA commissioner. Letter appears to reflect long-standing FDA concerns: Dsuvia was approved with a REMS related to administration issues, and Xeris received a similar warning letter last year for exaggerating the ease of use of its glucagon pre-filled syringe Gvoke PFS.

Public Company Edition: Among other recent large financings, BridgeBio Pharma launched a $650m note sale, CureVac closed a $517.5m follow-on offering and Revolution Medicines raised $260.9m.

Companies claim their technologies provide more precise editing as they raise funds, but CRISPR companies remain in the lead.

Astellas Pharma US accounts for roughly one-third of the parent company’s annual revenues with a growing focus on immuno-oncology. The unit’s president discusses lessons from the pandemic, racial disparities in health care and business development.