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Pandemic-Affected Trials Will Need Same Exploratory Analyses That US FDA Used To Save Aducanumab

 
• By Sue Sutter

Use of exploratory methods to understand as much as possible from the two Alzheimer’s disease drug trials that were terminated early for futility is the same type of ‘innovative thinking’ that will be needed to salvage information from neuroscience trials interrupted by the COVID-19, US FDA Office of Neuroscience director Billy Dunn says.

Shipwreck view from above
FDA said it was important to salvage as much information as possible from the terminated Phase III program. • Source: Shutterstock

The types of exploratory analyses that Biogen, Inc. and the US Food and Drug Administration are leaning on to conclude Aduhelm (aducanumab) is an effective Alzheimer’s treatment may offer a preview of the regulatory help and flexibility needed to salvage data from clinical trials disrupted by the COVID-19 pandemic.

However, an advisory committee’s rough reception of the results of these analyses for aducanumab portends the challenges inherent with using...

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AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

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