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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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.  ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →