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

EMA Confirms Fast-Track EUA-Style Review For Molnupiravir In COVID-19

Rolling Review Is Under Way But Could Take Some Time

Executive Summary

The EU regulator says it is taking the emergency use route for molnupiravir because of the worrying rise in coronavirus infections and deaths.

You may also be interested in...



COVID-19: French Reimbursement No For MSD’s Lagevrio But Yes For AZ’s Evusheld

The European Medicines Agency’s advice that Lagevrio could be considered for emergency use still stands despite new data.

Coronavirus Notebook: Molnupiravir EU Approval Likely By Year End, Special CHMP Session Due On Comirnaty in 5 to 11-year-olds

The EMA is assessing the Janssen vaccine as a booster, and Switzerland is evaluating the use of the Pfizer/BioNTech and Moderna COVID-19 vaccines in younger age groups. The WHO has announced the first voluntary global license on a COVID-19 antibody detection technology.

GSK/Vir’s Xevudy Begins EU Review For COVID-19

Things are happening very quickly on the COVID-19 front, with sotrovimab, molnupiravir, Paxlovid and Novaxovid all under EU review for marketing authorization or emergency use, and EMA decisions expected on boosters and the use of vaccines in younger age groups.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145221

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