EMA Reviews GSK/Vir’s COVID-19 Antibody To Support Early Use By Member States
After preliminary discussions with its pandemic task force, the European Medicines Agency has begun reviewing GSK/Vir Biotechnology’s promising COVID-19 treatment to help EU national competent authorities make evidence-based decisions on its possible early use.
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The European Medicines Agency has extended the time that Comirnaty can spend in a fridge after defrosting and could this week issue advice to member states on sotrovimab for use in COVID-19 patients. Norway’s BerGenBio has published top-line data from a Phase II trial of of bemcentinib, and IcanoMAB has outlined the potential of its anti-IL-1R7 antibody.
Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.
The company announced a $336m series C round, six months after it raised an $80m series B, to support development of an easily administered treatment ADG20.