1. Pink Sheet

Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent

 
• By Bridget Silverman

Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.

Blueprint-light-bulb

Biogen Inc. and Eisai Co. Ltd.’s decision to move ahead with a BLA submission for aducanumab in Alzheimer’s disease despite mixed clinical results stunned the pharma world, but a look at the history of the Center for Drug Evaluation and Research’s division of neurology products suggests that the application might find reviewers receptive to arguments that look to the totality of the evidence.

The aducanumab BLA will fall short of the gold standard of two well-controlled randomized clinical efficacy trials. Indeed, the Phase...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.

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• By Eliza Slawther

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• By Brian Bossetta

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More from Pathways & Standards

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

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