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.
After the differing second-quarter financial performances of Roche, AstraZeneca and Pfizer’s oncology franchises, the reports by Merck & Co and BMS should have helped define the effects of the pandemic on oncology businesses.
Investors in pharmaceutical companies appreciate details such as sales force dynamics, price-volume relationships and channel-stocking effects. Their absence can make investors wary.