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Biogen’s Aducanumab: One Positive Phase III Trial Is Good Enough For Demonstrating Efficacy, US FDA Says

 
• By Sue Sutter

Negative results from the Phase III ENGAGE trial – which may have been influenced by imbalance in ‘rapid progressors’ and differential effects of dosing protocol changes – do not negate persuasiveness of positive results from the EMERGE study, agency says in advisory committee briefing document; statistical reviewers dissent, call for a new trial of the Alzheimer's drug.

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US FDA believes the Phase III EMERGE trial can stand on its own as pivotal efficacy evidence for aducanumab. • Source: Shutterstock

Biogen, Inc.’s successful EMERGE study can stand on its own as pivotal efficacy evidence for the Alzheimer’s disease drug aducanumab despite the negative results from a second Phase III trial, the US Food and Drug Administration said.

In advisory committee briefing documents released 4 November, the agency said the negative ENGAGE trial (Study 301) “does not contribute...

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• By Bridget Silverman

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Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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• By Bridget Silverman

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America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

EU CHMP Opinions And MAA Updates

 
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Global Pharma Guidance Tracker - May 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.