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Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni

Executive Summary

Review extension for Alzheimer’s candidate may be positive for Biogen, but it’s not because Woodcock is acting commissioner. To understand the odds, it may be time to get to better know a new generation of US FDA’s drug review leadership.

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Aducanumab Approval Decision Delayed: What’s In The Major Amendment?

From EMBARK data to labeling materials, the potential reasons for the three-month user fee delay are as varied as the ups and downs of the Biogen/Eisai Alzheimer’s candidate’s development saga.

Aducanumab Approval Decision Delayed: What’s In The Major Amendment?

From EMBARK data to labeling materials, the potential reasons for the three-month user fee delay are as varied as the ups and downs of the Biogen/Eisai Alzheimer’s candidate’s development saga.

Biogen’s Aducanumab Falls Hard At Panel Review, Leaving US FDA In A Tight Spot

Successful EMERGE trial does not provide substantial evidence of efficacy in Alzheimer’s because it cannot be divorced from its unsuccessful sister study, advisory committee says; panel’s unequivocal rejection leaves agency’s Office of Neuroscience in a tight spot given its strong support for the drug and the help it gave Biogen to get this far.

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