Vertex, NHS (National Health Service) England, and the health technology appraisal body NICE have forgotten about patients in the impasse over access to cystic fibrosis drug Orkambi, says a patient representative who attended the recent hearing on the price of the drug.
The failure by Vertex Pharmaceuticals Inc., NHS England and NICE to find a way to provide access to the cystic fibrosis drug Orkambi (ivacaftor/lumacaftor) has been a huge blow to patients and has become something of a “pantomime”, according to a cystic fibrosis patient witness speaking at a public hearing last week.
“It looks as though the parties have become quite entrenched and dug their heels in, and no one wants to...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
