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

Hexal Sues EMA Over Refusal To Accept Generic Aubagio Filing

Executive Summary

Hexal is challenging a decision by the European Medicines Agency to reject its application for a generic version of Sanofi’s MS drug Aubagio, raising fresh questions about how a new active substance is defined. By contrast, a generic version from Glenmark was recently approved in the US.

You may also be interested in...



CHMP Thinking On Aubagio NAS Status Offers Useful Insights

The EU’s top drug advisory committee was divided on how to interpret regulations on new active substance status when it came to Sanofi's oral MS drug Aubagio, which was only given NAS status by a majority vote after the French group appealed an initial refusal. The CHMP’s thinking on the issue will be useful to others wishing to develop new medicines closely related to already-marketed products.

Denmark Planning To Impose Drug Stockpiling Obligations From July

A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.

National Drug Stockpiles Create ‘False Sense Of Security’

The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124370

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