Blog
RSS FeedPosted by Michael Wonder on 27 Sep 2023
Role of registries in Medicare coverage of new Alzheimer disease drugs
27 September 2023 - An amyloid-directed monoclonal antibody, lecanemab-irmb (Leqembi), was approved by the US FDA on 6 July 2023, to ...
Posted by Michael Wonder on 26 Aug 2022
Patient registries: EMA officials highlight opportunities in orphan drug development
25 August 2022 - Officials from the EMA tout the benefits of patient registries to support regulatory decision making for ...
Posted by Michael Wonder on 02 Feb 2022
Register study on gene therapy with Zolgensma starts
1 February 2022 - Experience from clinical practice with Zolgensma, a gene therapy against certain forms of spinal muscular atrophy in ...
Posted by Michael Wonder on 25 Jan 2020
Registry-data – of sufficient quality – are suitable for the extended benefit assessment of drugs
24 January 2020 - Rapid report shows how routine practice data should be collected and processed. ...
Posted by Michael Wonder on 30 Nov 2018
Data from patient registries to replace clinical trials in previously untreated haemophilia patients
30 November 2018 - EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications ...
Posted by Michael Wonder on 15 Nov 2018
EMA seeks feedback on using registries for regulatory purposes
15 November 2018 - The EMA is seeking feedback on the use of patient disease registries for regulatory purposes. ...
Posted by Michael Wonder on 26 Sep 2018
Quality assurance of registries for health technology assessment
25 September 2018 - The aim of this study was to identify guidelines and assessment tools used by health technology agencies ...
Posted by Michael Wonder on 22 May 2018
EMA report makes recommendations for CAR-T patient registries
22 May 2018 - A new report from the EMA lays out recommendations for improving the use of patient registries ...
Posted by Michael Wonder on 13 Oct 2015
Collecting high-quality information on medicines through patient registries
12 October 2015 - The European Medicines Agency (EMA) has launched an initiative on patient registries aimed at making better use ...