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US Vs EU: First Half 2021 Novel Approval Scorecard

 
• By Bridget Silverman and Neena Brizmohun

The Pink Sheet's table of the 55 novel products approved in either the US or EU during H1 2021 includes details on approval dates, use of special review pathways and review status such as orphan product or priority review.

Below are the 55 novel products approved in either the US or the EU during the first half of 2021. The overwhelming majority of these are US-first approvals and the data show much more impact during this period for the US breakthrough therapy designation but less for the the EU PRIME designation. Our accompanying article analyzes these trends. (Also see "US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development" - Pink Sheet, 30 August, 2021.)

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• By Neena Brizmohun

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New EU Approvals

 
• By Neena Brizmohun

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More from Product Reviews

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

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Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
• By Neena Brizmohun

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

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