France has reported on side-effect reports concerning the Pfizer/BioNTech vaccine, and the World Health Organization has warned that plans to provide global equitable access to coronavirus vaccines are at risk.
“Someone clearly does not want Europeans to get vaccinated.” So says cybersecurity consultant Lukasz Olejnik, after the European Medicines Agency said that the data on COVID-19 vaccines that was unlawfully accessed on its servers was “manipulated” before being leaked on the internet.
The documents included internal and confidential email correspondence dating from November 2020 and relating to the evaluation processes for COVID-19...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
