The company manufacturing Russia's Sputnik V vaccine in Brazil has produced the first batch, but has withdrawn a request to run clinical trials there. France is preparing to immunize the over-18s, and Australia has begun evaluating Vir/GSK’s sotrovimab for use in COVID-19 patients.
This week saw the official launch of the UK’s CovBoost study, which is intended to determine which vaccines will be the most effective as booster vaccinations in people who have already had two doses of a vaccine.
As well as studying combinations of seven different COVID-19 vaccines against a control group, the trial will examine whether a...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
