Blog
RSS FeedPosted by Michael Wonder on 27 Feb 2019
Celgene Corporation announces key regulatory update for Revlimid in lymphoma
26 February 2019 - U.S. FDA grants priority review for Revlimid (lenalidomide) in combination with rituximab for previously treated follicular and ...
Posted by Michael Wonder on 23 Feb 2019
FDA grants priority review and accepts sBLA of Soliris (eculizumab) as a treatment for patients with neuromyelitis optica spectrum disorder
22 February 2019 - FDA sets action date of 28 June 2019. ...
Posted by Michael Wonder on 05 Feb 2019
EMA grants PRIME eligibility for potential next-generation RSV medicine MEDI8897
5 February 2019 - First EMA PRIME eligibility for AstraZeneca. ...
Posted by Michael Wonder on 18 Dec 2018
Eiger announces PRIME designation granted by European Medicines Agency for lonafarnib for treatment of hepatitis delta virus infection
18 December 2018 - Phase 3 hepatitis D virus “D-LIVR” international study initiating. ...
Posted by Michael Wonder on 17 Dec 2018
PRIME designation granted by European Medicines Agency for Roche’s risdiplam for treatment of spinal muscular atrophy
17 December 2018 - Risdiplam has the potential to be the first oral medicine for the treatment of SMA. ...
Posted by Michael Wonder on 21 Nov 2018
Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy application
20 November 2018 - EMA and the US FDA are organising a workshop on 26 November 2018 to discuss how ...
Posted by Michael Wonder on 15 Nov 2018
Modis Therapeutics announces PRIME designation granted by the EMA to MT1621 for the treatment of TK2 deficiency
13 November 2018 - Modis Therapeutics announced today that the EMA has granted PRIME (PRIority MEdicines) designation to MT1621, Modis’ investigational ...
Posted by Michael Wonder on 06 Nov 2018
Sankyo’s FLT3 inhibitor quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
5 November 2018 - Application based on results of pivotal phase 3 QuANTUM-R study of quizartinib in patients with relapsed/refractory FLT3-ITD ...
Posted by Michael Wonder on 05 Oct 2018
Orchard Therapeutics receives EMA PRIME designation for OTL-300, an investigational lentiviral gene therapy for the treatment of transfusion-dependent beta thalassaemia
4 October 2018 - Orchard Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) designation to OTL-300, an ...
Posted by Michael Wonder on 14 Sep 2018
EMA Priority Medicines scheme (PRIME): will more paying-for-performance agreements be needed due to immature data?
14 September 2018 - The EU’s centralized procedure for the authorization of a new drug is performed by the EMA. ...
Posted by Michael Wonder on 07 Aug 2018
The European Medicines Agency: PRIME’d for access?
7 August 2018 - Regulators around the world have been working for decades to speed up access to the best ...
Posted by Michael Wonder on 04 Aug 2018
EMA grants PRIME status for Roche Huntington's drug
3 August 2018 - The EMA has granted PRIME designation to Roche's RG6042 for treatment of Huntington’s disease. ...
Posted by Michael Wonder on 02 Aug 2018
FDA and EMA to hold workshop on breakthrough therapy and PRIME designations
2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...
Posted by Michael Wonder on 01 Aug 2018
EMA confirms accelerated assessment procedure for Trogarzo
31 July 2018 - Theratechnologies is pleased to announce that the CHMP of the EMA will review the application for marketing ...
Posted by Michael Wonder on 27 Jul 2018
bluebird bio’s LentiGlobin gene therapy granted accelerated assessment by EMA for the treatment of transfusion-dependent β-thalassemia
26 July 2018 - Company on track to submit marketing authorisation application in European Union in 2018. ...