EFPIA has welcomed an evidence-based report on the regulatory flexibilities used in Europe during the pandemic and how they could be further employed in future. The EMA’s drug safety committee is looking at more reports of menstrual disorders with mRNA vaccines.
The Access to COVID-19 Tools (ACT) Accelerator has called on higher-income countries to pay their “fair share” of the funding that is still needed to procure COVID-19 vaccines, medicines and other medical products for use in low- and middle-income countries.
“With a significant proportion of the global population still unable to get vaccinated, tested or treated, US$16bn in grant funding...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
