With the approval of Nuvaxovid, the UK and the EU now each have five COVID-19 vaccines at their disposal. Meanwhile, the European Medicines Agency has given an estimated timeline for the approval of candidate vaccines from Valneva and Sanofi Pasteur, and is looking at which therapeutics could be effective against the Omicron variant. Russia says its Sputnik V vaccine has now been granted full regulatory approval there.
This week saw the UK regulator, the MHRA, issue a conditional marketing authorization (CMA) for a fifth COVID-19 vaccine, Novavax, Inc.’s Nuvaxovid. Unlike other vaccines on the market, Nuvaxovid is based on recombinant protein-based technology.
“It is great to see our world renowned medicines regulator approve another COVID-19 vaccine,” said health and social care secretary...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
