The director of the World Health Organization and the NGO, Médecins Sans Frontières, have both called for monopolies on COVID-19 products to be waived during the pandemic. And confounding critics, new analysis in The Lancet shows the Oxford/AZ vaccine works best with a 12-week dosing interval.
The UK is preparing to conduct a clinical study looking at the effects of giving people a different coronavirus vaccine for their first and second dose, for example the Oxford University/AstraZeneca PLC vaccine followed by the Pfizer Inc./BioNTech SE jab, or vice-versa.
The government said that the study, the first of its kind in the world, was being undertaken to see whether...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
