Coronavirus Notebook: UK Adds Paxlovid To PANORAMIC Study, Germany Funds Adrecizumab Phase II Trial
RedHill’s opaganib has shown “potent inhibition” of the Omicron variant in early studies, while the EMA has found no links between the mRNA vaccines and autoimmune hepatitis.
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As work continues on vaccines adapted to tackle variants of SARS-CoV-2, the EU regulator says the decision-making on such products should take place at a global level.
The new regulation on cross-border threats to health is the final part of the European Health Union, along with strengthened roles for the European Medicines Agency and the European Centre for Disease Prevention and Control. Its aim is to ensure collective EU action on preparedness, surveillance, risk assessment, and early warning and response in the event of health emergencies.
Experiences during the COVID-19 pandemic are expected to help identify future opportunities for regulatory cooperation on real-world evidence and avoid divergent decision-making for products including advanced therapies and personalized medicines.