EU Approves Paxlovid For COVID-19
The European Medicines Agency’s assessment of the oral antiviral combination was conducted under the OPEN Initiative, which involves information sharing among international regulators.
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With the approval of Nuvaxovid, the UK and the EU now each have five COVID-19 vaccines at their disposal. Meanwhile, the European Medicines Agency has given an estimated timeline for the approval of candidate vaccines from Valneva and Sanofi Pasteur, and is looking at which therapeutics could be effective against the Omicron variant. Russia says its Sputnik V vaccine has now been granted full regulatory approval there.
Pfizer gets European Commission approval for Paxlovid after a positive CHMP opinion, while Moderna started a Phase II study of its Omicron-specific vaccine candidate. Meanwhile, China's Junshi enters into a new oral antiviral collaboration while Daiichi Sankyo investigates its mRNA vaccine contender as a booster shot.
Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.