Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

European Countries Issue Alzheimer’s Biomarker Warning

Executive Summary

Biogen/Eisai’s Alzheimer’s drug aducanumab could face difficulties with health technology appraisal institutes should it win approval in the EU.

You may also be interested in...



AlzeCure Hunts For Small Molecules In Its Alzheimer’s Quest

Emerging Company Profile: Swedish biotech AlzeCure is developing a portfolio of small-molecule drug candidates for diseases affecting the central nervous system, including Alzheimer’s disease and pain.

Strength in Numbers: EU Cross-Country Drug Pricing Coalitions Join Forces

Two groups of smaller European countries have agreed to collaborate on tackling challenges relating to accessing expensive new medicines.

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA advisory committee; approval raises feasibility questions about confirmatory trial and daunting prospect of market withdrawal if studies fail to verify clinical benefit.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144570

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