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

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

Executive Summary

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.

You may also be interested in...



Merck & Co. Eyes Neuroscience Advancement With US FDA’s New Receptivity To Biomarkers

Company is ‘anxious to understand’ how to utilize the agency’s views on importance of biomarkers, exec notes in earnings call. Merck & Co. and Pfizer advance COVID-19 therapeutics into Phase III. Pfizer is awaiting FDA risk-benefit assessment of JAK-1 inhibitors Xeljanz and abrocitinib.

Aduhelm’s ‘Complex’ Circumstances Drove Extensive In-House Advice Process Before Accelerated Approval, Cavazzoni Says

Accelerated approval was considered as option in response to the negative advisory committee vote, but it was not a ‘default,’ CDER officials say. ‘It fit like a glove.’

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.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS143231

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