The European Medicines Agency has extended the time that Comirnaty can spend in a fridge after defrosting and could this week issue advice to member states on sotrovimab for use in COVID-19 patients. Norway’s BerGenBio has published top-line data from a Phase II trial of of bemcentinib, and IcanoMAB has outlined the potential of its anti-IL-1R7 antibody.
It has been shown for the first time that a combination of two different COVID-19 vaccines can produce high immunogenicity in patients, with no unexpected side-effects.
On 18 May, Spain’s Carlos III Institute of Health presented the results of the CombivacS study, a Phase II randomized,...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
