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


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.

Bavarian Nordic To Supply Vaccine As Monkeypox Appears In UK & Portugal

The monkeypox cases reported this month are evidence of chains of transmission of the virus, according to the European Centre for Disease Prevention and Control, which says that vaccination of high-risk close contacts should be considered after a benefit-risk assessment.

Coronavirus Notebook: WHO Says Extra Vaccine Boosters Confer Some Limited Benefits, Emergex & Zosano Link Up On T Cell Vaccine Patch

International regulators have issued an updated statement on the benefits and safety of COVID-19 vaccines for use by health professionals, while the UK BioIndustry Association has welcomed a MAb licensing deal between AstraZeneca and UK-based biotech firm RQ Bio.


Related Companies




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