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2020 Sees Sharp Rise In EU New Drug Approvals

Products Include COVID-19 Vaccine & Remdesivir, Plus Three Gene Therapies

 
• By Ian Schofield

The number of new drugs containing new active substances approved in the EU rose significantly in 2020, underpinned by a strong showing for orphan-designated products and a string of novel medicines for cancer and infectious diseases. Notable among the new clutch of approvals was the first ever COVID-19 vaccine, Pfizer/BioNTech's Comirnaty.

Pills with euro union flag, medicine
The EU approved a range of novel drugs last year • Source: Shutterstock

In 2020, 42 products containing a total of 41 new active substances received an EU marketing authorization, a sharp increase on the 28 NAS-containing products that were cleared in 2019, and just short of the three-year peak of 45 seen in 2018.

Among the most high-profile products to be approved last year were Pfizer Inc./BioNTech SE’s Comirnaty, the first vaccine...

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