I met the management of InterMune Inc. almost 20 years ago when it was a mid-sized US biotechnology company that had three approved products, two of them interferons. Virtually all of InterMune’s revenues came from one product − Actimmune (interferon gamma 1b), originally licensed from Genentech Inc. in 1998.
Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work
How Sarepta And Biogen Are Following The Actimmune Playbook
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.
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