The Scottish health technology appraisal body also OKd Janssen's Ponvory and new indications for AstraZeneca’s Tagrisso, Roche’s Tecentriq and MSD’s Keytruda. It also said it could not make recommendations on a number of drugs because manufacturers had not made a submission to the SMC.
In its latest raft of advice, the Scottish Medicines Consortium (SMC), Scotland’s health technology appraisal body, has accepted UCB’s potential mega blockbuster psoriasis drug Bimzelx (bimekizumab) for use on the Scottish National Health Service following a fast-track process.
The SMC made a restricted recommendation for Bimzelx for plaque psoriasis patients who have failed to respond to standard systemic...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
