The European Commission has dismissed concerns about the operation of its new emergency response body, saying it will ensure the EU is well prepared for tackling future pandemics and other threats. HERA will complement, not duplicate, work conducted by existing agencies such as the European Medicines Agency, delegates heard at this week’s European Health Forum Gastein virtual conference.
The European Health Emergency preparedness and Response Authority (HERA) will be officially established on 1 October, tasked with making sure the EU is prepared for future health emergencies, with a particular focus on the development, availability and affordability of medical countermeasures such as vaccines and therapeutics.
HERA, which will have €6bn ($7bn) in funding over the next six years, will “ensure a solid framework for EU...
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
