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.
2020 Sees Sharp Rise In EU New Drug Approvals
Products Include COVID-19 Vaccine & Remdesivir, Plus Three Gene Therapies
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.
More from Europe
• By
Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.
• By
The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
• By
The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.
• By
While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.
More from Geography
• By
The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration.
• By
The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.
• By
Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.