FDA leadership has generally seemed apprehensive of going too hard on companies that don’t meet clinical trial diversity goals, but some industry insiders say a stronger FDA is needed to spark real change. Delayed guidance could indicate if the agency will change course.

The Japanese company will await imaging results to see if AC Immune’s candidate ACI-24.060 can help prevent or remove plaques before finalizing the deal.

Private Company Edition: Regeneron launched a $500m venture fund and Canaan added $100m, bringing the venture firm’s recent total to $1bn-plus. Also, incubators plan to grow over the next decade and in recent financings Avenzo raised $150m and Nvelop launched with $100m.

Others have tried and failed to target α-synuclein in Parkinson’s disease, but Roche hopes a Phase II study could deliver success later this year.