Lupin and patient groups have slammed NICE’s “unprecedented” preliminary decision not to mandate funding for the repurposed rare disease treatment Namuscla for patients on England’s National Health Service who are already taking the drug. The move could set a precedent and is concerning for patients and R&D investments, says the company.
UK health technology assessment (HTA) body NICE has defended its negative draft guidance that if unchanged would mean that patients receiving Lupin Limited’s repurposed drug Namuscla (mexiletine) for ultra-rare nondystrophic myotonic disorders (NMD) on the National Health System since 2019 would no longer receive the treatment.
NICE says it is the first time it has made such a decision and that recommending that these patients continue...
<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>
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
