It’s all go on the EU coronavirus front this week: three new therapies and another vaccine booster have been recommended for use, and a special session on the Novavax vaccine is to be held at the EMA next week. More production capacity has been OKd for three vaccines.
The European Medicines Agency’s human drugs committee, the CHMP, will discuss Novavax, Inc.’s Nuvaxovid at an extraordinary meeting on 20 December where it could well advise that the coronavirus vaccine should be approved. The agency has also recommended the use of a booster dose of Janssen’s approved vaccine.
In addition, the CHMP has given the green light to two potential therapies for COVID-19, Xevudy and Kineret, and has...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
