The pharmaceutical industry in Europe has attacked the US decision to come out in support of a relaxation of IP rights that is designed to boost global production of COVID-19 vaccines. But the move by the Biden administration could well cause other countries to rethink their opposition to the move.
Opposition to a proposed waiver of intellectual property rights to boost the global availability of COVID-19 vaccines appears to be weakening after the EU said it was willing to discuss the proposal in light of the US government’s ground-breaking decision to back the waiver.
The temporary waiver, which was first proposed last year by South Africa and India in a submission to the World...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
