Even if the FDA tells a sponsor to do a particular study or a randomized controlled study, if it’s not going to work, “don’t do it,” former CDER Director Janet Woodcock said.
Regulatory uncertainty and US policy issues are constraining dealmaking activity, despite conditions that should be producing a healthy stream of transactions, PwC contends.
Long-term relationships help ease partnership negotiations, Novartis and Anthos said during a panel on the big pharma’s approach to partnering.
With the IPO window closed, Generate is considering its options to finance moving its lead candidate, GB-0895, into Phase III testing.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

Updates From Day 4 Of BIO