EU Court Says Orphan Designation Possible For Same But Better Drugs
Executive Summary
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.
You may also be interested in...
Court Ruling A ‘Sea Change’ For EU Orphan Designation
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.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.