EMA mulls appeal after EU court rules against trial data disclosure
This article was originally published in SRA
The European Medicines Agency says it may appeal against interim rulings by the EU General Court ordering it to refrain from publishing clinical trial data on AbbVie's Humira (adalimumab) and Intermune's Esbriet (pirfenidone) pending a final decision from the court1.
You may also be interested in...
A legislative provision under which future COVID-19 vaccines can be made available in the UK before they are approved is also being used to offer an unlicensed flu vaccine that officials say has undergone full safety, efficacy and quality tests.
With product shortages made worse by the pandemic, companies in the UK are being asked to use a new system for notifying potential supply disruptions and any plans to discontinue specific medicines.
Two new projects have begun, one on standardizing the assessment of immune responses in individuals vaccinated in clinical trials, the other to improve understanding of potential immunity in patients who have been infected with SARS-CoV-2.