Orchard Therapeutics has secured reimbursement in Ireland, the Netherlands and Belgium nearly a year after the collapse of joint pricing talks between the company and the three countries.
Additional long-term data from Orchard Therapeutics has convinced Ireland, the Netherlands and Belgium to reimburse the company’s costly gene therapy Libmeldy (atidarsagene autotemcel). The three countries, working together under the BeNeLuxA cross-country initiative, had previously said the drug was too expensive.
“We are pleased to have reached an agreement with the BeNeluxA consortium that enables sustainable access to treatment. The agreement...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
