Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



FDA Neuroscience Director Dunn's Appearance At Tanezumab AdComm Confirms Neurology Office Is Intact

Dunn’s participation at the panel meeting ended speculation that he left the US FDA.

US FDA’s Woodcock Rejects Firewall Between Presubmission Advice And Application Review

Public Citizen proposal that FDA staff who provide presubmission advice on a development program not be involved in reviewing the subsequent product application would cause significant public health repercussions and delay drug development, acting commissioner says; Public Citizen had cited ‘close collaboration’ between the FDA and Biogen on aducanumab in calling for the separation.

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

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.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS143701

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel