The UK government is proposing to take the "very unusual step" of making COVID-19 vaccines available before they are licensed. The international COVAX initiative is now supporting nine vaccines, and the EU and AstraZeneca have firmed up a vaccine purchase agreement.
In a major move to ensure the UK is ready to make a future COVID-19 vaccine available as quickly as possible, the government has published proposals to amend the medicines regulations to allow the use of an unlicensed vaccine "if there is a compelling case, on public health grounds," for doing so.
In a document published on 28 August, the government says it is "not clear what the earliest date is that...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
