A new study shows that the immune response to Pfizer/BioNTech’s Comirnaty in elderly people is 3.5-fold greater when the second dose is given after 12 weeks rather than three. The WHO has OKd the emergency use of a Chinese vaccine.
The European Medicines Agency is taking further action to streamline activities carried out by the EU’s medicines regulatory network to allow experts to deal with a rising number of assessment procedures related to COVID-19 products.
With the “very active pipeline” of upcoming coronavirus vaccines and therapeutics, a number of ongoing procedures, and the rollout of...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
