A comparison of EU approvals of medicines containing a new active substance in the first six months of 2021, 2022 and 2023 shows a sharp decline in the 2023 first-half numbers. Three of the products approved by the European Commission in the first six months of this year were for cancer, while two were for infectious diseases (including HIPRA’s COVID-19 vaccine Bimervax). Two products had orphan drug status.
The number of medicines containing a new active substance (NAS) authorized for marketing by the European Commission fell sharply in the first half of 2023, to just 11. This compares with a total of 27 NAS-containing products approved in the first half of 2022, and 28 in the same period of 2021.
The reasons for the decline in EU marketing authorizations up to the end of June are not clear – while...
<p>Executive Summary</p> <p>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.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
