Industry keeps up the pressure on UK early access scheme; new 'promising innovation medicine' designation in sight
This article was originally published in Scrip
Executive Summary
The life sciences industry in the UK is continuing to put pressure on the government in an effort to make it deliver on the much-vaunted but still-to-materialize early access to medicines scheme. There is speculation that an announcement on the scheme is not far off, with a new “promising innovation medicine” designation expected to be introduced as part of it.
You may also be interested in...
EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
EU Accelerated Assessment Tracker
The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.
AZ Secures EU Fast-Tack Review For Nirsevimab
There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.