Bluebird bio’s decision to focus on the US market is being seen as a broader signal of the need for changes in market access policies to enable gene therapies to be made available for European patients. Only collaborative work will create solutions acceptable to payers and companies, and finding an acceptable price that both can live with will be crucial.
Stakeholders from within life sciences say that the decision bluebird bio has made to focus on the US to commercialize its gene therapies sends a worrying signal about the attractiveness of Europe. European payers and companies need to get serious about finding solutions to the pricing challenge to avoid false hope for patients in future, the argue.
That is becoming ever more urgent, with five gene therapies currently under review by the European Medicines Agency. (Also see...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
