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

AbbVie drops lawsuit against EMA after data redaction agreed

This article was originally published in SRA

Executive Summary

AbbVie has withdrawn its lawsuits against the European Medicines Agency after the agency accepted a new set of redacted documents submitted by AbbVie, along with the company's rationale for removing certain commercially confidential information from the clinical study reports that are at the center of the litigation1,2.

You may also be interested in...



Boost For Transparency As EU Court Backs EMA's Approach To Disclosing Clinical Data

The EU General Court has dismissed three cases by pharmaceutical companies that wanted to prevent the European Medicines Agency from disclosing certain data about their marketed medicines on the grounds that it would harm their commercial interests. Firms now have a clearer idea of the standards they will need to meet to claim their information is commercially confidential.

EU Preparing Guidance On Synthetic Oligonucleotides & Peptides

Two new quality guidelines are needed to address the increase in applications for clinical trials and marketing authorizations of oligonucleotide- and peptide-based medicines, says the EU regulator.

EU Gears Up For Compulsory Licensing Reform

The European Commission has laid out a number of possibilities for changing the EU framework on compulsory licensing to improve the availability of products in health emergencies. The options include extending the scope of compulsory licences beyond patents to other forms of protection such as data exclusivity.

Latest News
See All
UsernamePublicRestriction

Register

PS117773

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