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.
If demand-side pressures on the life science sector were not enough, generic price erosion, debt repayment and extended restructurings are worsening the generic pharmaceutical investment proposition.
Depending on the therapeutic area, a fall in pharmaceutical sales was an obvious effect of the pandemic, although lower selling and marketing expenses and fewer non-COVID-19 infections were minor positives.