Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work
How Sarepta And Biogen Are Following The Actimmune Playbook
Executive Summary
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.
You may also be interested in...
Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate
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.
Stock Watch: Risk And The Pharmaceutical Discount Rate
In contrast to the SEC’s view that public companies’ regulatory filings give investors all the information needed to make an investment decision, the discount rate used to value a company may not reflect all its risks.
Stock Watch: Pharma Businesses That Leave Consumer Behind
Healthcare conglomerates that divorce consumer, animal health and even generics businesses from their pure-play branded pharmaceutical groups could leave a less diversified and riskier sector in uncertain times. But the advantages are apparent.