Cuba is about to begin Phase III trials with one of its four homegrown coronavirus vaccines, Australia has provisionally approved the AstraZeneca/Oxford University product, and the EU has upped its orders from Pfizer/BioNTech and Moderna.
The UK’s clinical trials ethics body has given the go-ahead to the world’s first COVID-19 human challenge study in an effort to better understand how the virus works in the body and help to develop new vaccines and treatments for the disease.
The initial virus characterization study is expected to begin within the next few weeks. It will recruit up to 90...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
