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EU Biosimilar Filings, Opinions And Approvals

Executive Summary

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

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EFPIA On How To Prepare EU For Future Health Crises

A report from industry federation EFPIA and its Vaccines Europe arm says that R&D has produced safe and effective tools for tackling COVID-19 but that the EU needs to address a set of short- to medium-term priorities if it is to be in a position to tackle future health emergencies.

COVID-19 Summit Sees Progress On Test-And-Treat, IP Licensing, & Funding Commitments

Announcements at the second Global COVID-19 Summit included a technology licensing agreement for vaccine and diagnostic products developed by the US NIH, a new partnership to boost the use of testing and antiviral treatments in less wealthy countries, and a flurry of new funding pledges from organizations and companies alike.

EMA To Draw Up 'Critical Medicine' Lists For Future Health Crises

As part of its expanded mandate, the EU regulator is identifying those medicines whose supply will need to be closely monitored during health crisis situations. The lists will draw on various information sources, including real-world evidence databases.

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