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

UsernamePublicRestriction
UsernamePublicRestriction

European Performance Tracker

Set Alert for European Performance Tracker

European CHMP Opinions And MAA Updates

This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

 

Drug Review Approvals

New EU Approvals

Ten new products including Spark Therapeutics' gene therapy for treating patients with an inherited retinal disease, Luxturna, have been added to the Pink Sheet’s 2018 list of EU centralized approvals of new active substances. The list includes brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).

Approvals Europe

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

European Performance Tracker Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.
Drug Review Europe

EU Accelerated Assessment Tracker: Second Half Trumps First By Far

The first half of the year was pretty bleak for companies seeking fast-track review of their products in the EU. There has been much better news in the second half. The Pink Sheet tracks the winners and losers.

Europe European Performance Tracker

New EU Approvals

Six new products, including Eli Lilly's breast cancer drug Verzenios, have been added to the Pink Sheet’s 2018 list of EU centralized approvals of new active substances. The list includes brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
Approvals Europe
See All
UsernamePublicRestriction

Register