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 Director-Nominee Guido Rasi Brings Track Record For Repairing Regulatory Agency Reputation

This article was originally published in The Pink Sheet Daily

Executive Summary

Rasi leads the Italian Medicines Agency, an agency also known for conditional reimbursement agreements.

You may also be interested in...



EMA’s Heralded Revamp May Be Hampered By Tight Budget And Staffing

The EMA has announced a major restructuring plan to better aid its stakeholders, but tight staffing levels and budget stagnation could hamper the effort.

European Generics Applications Fall, As EMA’s Interim Report Hopes To Herald Funding Renewal

European Commission intervention has stopped duplicate generic applications. EMA hopes to end its budget row with the EU Parliament by focusing on transparency and conflict of interest disclosures.

Biosimilars Guidance On Interferon Beta From EMA Foreshadows Possible Joint EU/U.S. Approach

EMA’s biosimilars interferon beta guideline, which says that magnetic resonance imaging of disease lesions may be enough to demonstrate similarity. More important perhaps, it’s the first guidance issued under the watch of new EMA chief Guido Rasi, who strongly supports allowing single data package for EU and U.S. biosimilar medicines.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS072484

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