The European Medicines Agency says hacked COVID-19 vaccine data has been leaked online, and Australia’s chief medical officer defends the Oxford/AstraZeneca vaccine against scientists’ claim that it is not effective enough.
This week the European Commission announced that it had concluded exploratory talks with Valneva SE on an advance purchase agreement for 30 million doses of the French firm’s coronavirus vaccine, with the option to buy a further 30 million.
This is the eighth vaccine the commission is purchasing on behalf of the member states, having already signed contracts with...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
