Vertex has come under fire for its alleged extreme rigidity on pricing for its cystic fibrosis drug in England.
The national health service in England and the UK health technology assessment body NICE have attacked Vertex Pharmaceuticals Inc. for refusing to budge on the price of its cystic fibrosis drug Orkambi (ivacaftor/lumacaftor) and have criticized the company for instead trying to change the HTA process to secure the revenue that it wants.
The criticism came during a heated public hearing that was held as part of a parliamentary inquiry into the availability...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
