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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CDER Director Woodcock grants accelerated approval after FDA Commissioner Califf refuses to overturn her finding that the drug's effect on dystrophin is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy.
An early high for Pfizer with its strong first-quarter results was followed by patent waiver worries. At the other end of the spectrum, Esperion reminded us of the challenges in making a commercial success as a small biopharma firm in the pandemic.
Novartis’s comparatively anemic revenue growth and Lilly’s sales shortfall suggest that hopes for an immediate sector recovery from the pandemic are premature.