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
UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



GemVax's Novel Peptide For Alzheimer’s Set To Advance After Positive Phase II

GemVax unveils positive topline results for South Korean Phase II study of novel peptide drug targeting patients with moderate to severe Alzheimer’s disease, raising hopes for the upcoming US trials.

US FDA's New Neurology Leadership Likely To Face Two Big Reviews In 2020

Eric Bastings will lead Division of Neurology I, which is expected to handle Biogen’s Alzheimer’s drug aducanumab and Sarepta’s refiling of golodirsen for DMD next year.

CNS 'Graveyard Of Drug Development' Needs Oncology-Like FDA Regulatory Approach

Lundbeck executive calls for adaptive trial designs, transdiagnostic approach, and more scientific discussions between sponsors and the US Food and Drug Administration.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141164

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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