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.
The stock price performances of the top two coronavirus vaccine producers are inversely correlated to their sales and pipelines. There seems to be an expectation of declining coronavirus vaccine sales for some, but not for others.
From clinical trials to in-person sales calls, the pharmaceutical value chain has been tested by the COVID-19 pandemic, but has held up. Nevertheless, recent friction within this chain may be more than a passing irritation.