Pink Sheet is part of the Business Intelligence Division 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


Biogen Spinraza Approval: The Perfect Antidote To Sarepta Headlines?

Executive Summary

Approval of Biogen/Ionis’ Spinraza gives the drug development community a successful, collaborative model for a rapid pathway to full approval for a rare disease therapy; it also provides a timely, compelling rebuttal to claims that US FDA’s drug review operations are in dire need of reform.


Related Content

Biogen's Experience Highlights Challenges With Expanded Access Programs
BioMarin's Brineura Approval Shows FDA's Open Door For Orphan Drugs
SMA Patient Meeting Showcases FDA Flexibility – And Appreciation From Advocates
'Right To Try' Bill Contradicts US FDA’s Mission, Former Official Says
Patient Pushback On FDA Reform: Efficacy Matters
Biogen/Ionis’s Spinraza Approved; Second Antisense Drug For Neurodegeneration In 2016
Political Appointees Shouldn't Influence Approval Decisions, Califf Says
No More Sarepta-Like Development, FDA Officials Say
Anthem Denies Coverage For Eteplirsen, Citing Lack Of Clinical Efficacy
Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate


Related Companies




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