A rolling review of an adapted version of Moderna’s COVID-19 vaccine Spikevax aimed at variants of SARS-CoV-2 has begun at the European Medicines Agency. The EMA has also given an update on its latest vaccine safety reviews, including reports of heavy menstrual bleeding with Spikevax and Comirnaty.
The European Medicines Agency has begun a rolling review of a bivalent version of Moderna, Inc.’s COVID-19 vaccine, Spikevax, that targets the original strain of the virus as well as the Omicron variant of concern.
As with the variant-adapted version of Pfizer Inc./BioNTech SE’s Comirnaty, whose rolling review at the EMA began on...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
