Pink Sheet 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

Court Ruling A ‘Sea Change’ For EU Orphan Designation

Executive Summary

A ruling from the EU's top court says the European Medicines Agency was wrong to reject Shire Pharmaceuticals’ application for orphan designation for a new product on the grounds that the active substance it contained already had orphan status. The decision is seen as offering significant opportunities for the R&D-based pharmaceutical industry.

You may also be interested in...



EU Ruling Raises New Questions For Orphan Designation

An EU court has upheld a decision to revoke the orphan designation awarded to GMP-Orphan's trientine product for Wilson's disease, saying that the product no longer met the “significant benefit” criterion on the grounds of lack of availability of another drug. The case has raised questions about the level of evidence needed to justify a significant benefit. 

EU Court Ruling Puts Pressure On Orphan Drug Developers

A recent ruling by the EU’s General Court has backed a decision to strip BMS’s multiple myeloma drug Empliciti of its orphan status on the grounds that it did not offer a “significant benefit” over Amgen’s Kyprolis. The case highlights the difficulty of providing convincing evidence of comparative benefit amid the growing number of orphan drugs coming through the development pipeline.

EU Court Says Orphan Designation Possible For Same But Better Drugs

The European General Court says that companies are entitled to an independent and new period of orphan market exclusivity for a product that is highly similar to a previously authorized orphan drug.

Topics

Related Companies

UsernamePublicRestriction

Register

PS140608

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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