Expectations will be high after the COVID-19 product IP waiver plan took a big step forward and G7 leaders prepare for discussions on the global recovery from coronavirus, tackling climate change and other weighty subjects.
Obstacles to a temporary waiver of intellectual property rights on COVID-19 medical products appear to be falling away after the European Parliament came out in favor of the idea, and a key World Trade Organization body voted to take the proposal forward.
In a resolution adopted on 10 June, the parliament calls for “proactive, constructive and text-based negotiations” on a temporary waiver...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
