With the backdrop of Biogen’s BLA filing, and the FDA’s expected response for aducanumab in Alzheimer’s disease in 2020, the link between efficacy and approval seems to have broken. Conditional FDA approvals can’t help when the conditions are ignored. I met the management of InterMune almost 20 years ago when it was a mid-sized US biotechnology company … Continue reading “Lax Approval Requirements Yield Blockbusters That Don’t Work”