As the US firm prepares to ramp up production of the antiviral for use in coronavirus patients, a debate is growing over whether changes could be made to EU rules that prevent the importation of generic drugs produced under a compulsory license.
Amid concern over the availability of sufficient quantities of Gilead Sciences, Inc.’s remdesivir for treating coronavirus patients in Europe, the company says it is discussing "multiple options" with the European Commission “with the goal of getting remdesivir to European patients as quickly as possible.” Remdesivir was recently approved in the EU for use in COVID-19.
The EU health commissioner, Stella Kyriakides, met company executives on 6 July to discuss supplies of remdesivir for 16 EU...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
