EMA letters reveal extent of Abbvie/InterMune data disclosure concerns
This article was originally published in SRA
In trying to prevent the European Medicines Agency from releasing clinical trial data on its blockbuster product Humira (adalimumab), Abbvie is claiming not only that the documents in question are commercially confidential, but that releasing them would be a breach of copyright law1,2.
You may also be interested in...
A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.
Russia seeks WHO endorsement of its Sputnik V vaccine, a UK BioIndustry Association taskforce identifies potential new antibody cocktails, and the European Centre for Disease Prevention and Control considers the best strategies for targeted vaccination programs.
New guidance from the UK covers the recognition of EU approvals, accelerated assessment, rolling reviews, and much else besides.