The European Commission is to present the World Health Organization with a set of proposals to tackle the barriers to the global rollout of COVID-19 vaccines. They include allowing the issue of compulsory licenses without consulting the rights holder, encouraging vaccine companies to expand production through licensing deals and contract manufacturing, and eliminating vaccine export restrictions.
The prospects of a waiver of intellectual property rights for COVID-19 products are looking increasingly shaky after the European Commission and the Council of the EU said they would prefer less drastic action, such as voluntary or compulsory licensing, knowledge sharing and expanding vaccine production facilities.
On 19 May, the day that the EU passed the 200 million vaccination mark, the commission outlined a set 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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
