Scrip 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

France, Ireland oppose Mysimba EU approval on safety/efficacy grounds

This article was originally published in Scrip

Executive Summary

The EU CHMP's decision to recommend approval of Orexigen's weight loss combination product Mysimba (naltrexone/bupropion) has come under fire from the French and Irish regulatory agencies, whose representatives voted against the product's approval on safety and efficacy grounds at the committee's December meeting and have detailed their objections in a written statement.

You may also be interested in...



Coronavirus Notebook: MHRA Begins Rolling Review Of Moderna Vaccine, Sanofi/GSK Hook Up To COVAX

Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.

UK Confirms It Will Accept EU Marketing Authorizations For Two Years

New guidance from the UK covers the recognition of EU approvals, accelerated assessment, rolling reviews, and much else besides.

Brexit: Life Science Firms In An ‘Impossible Position’

As negotiations between the UK and EU enter a crucial phase, the UK life sciences industry has called for more clarity and guidance on what companies can expect to face at the end of the Brexit transition period. 

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134446

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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