Blog
RSS FeedPosted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...
Posted by Michael Wonder on 30 Jul 2019
Novartis’ Zolgensma joins growing list of medicines to lose accelerated assessment status in EU
29 July 2019 - The EMA's CHMP recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene ...
Posted by Michael Wonder on 30 Jul 2019
EMA grants PRIME access to ProQR’s sepofarsen for Leber’s congenital amaurosis 10
29 July 2019 - Access based on positive interim analysis of clinical data as well as preclinical data to date. ...
Posted by Michael Wonder on 16 Jul 2019
Caladrius Biosciences receives advanced therapy medicinal product classification for CLBS12, its CD34+ cell therapy for critical limb ischaemia
15 July 2019 - Caladrius Biosciences announced today that the EMA has granted Advanced Therapy Medicinal Product classification to the Company’s ...
Posted by Michael Wonder on 04 Apr 2019
EMA grants PRIME designation to Janssen’s investigational CAR-T therapy
4 April 2019 - Johnson & Johnson’s Janssen has announced the granting of a PRIME (PRIority MEdicines) designation for its ...
Posted by Michael Wonder on 02 Apr 2019
EMA grants PRIME eligibility for KB103 to treat dystrophic epidermolysis bullosa
29 March 2019 - First EMA PRIME eligibility for Krystal Biotech. ...
Posted 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 ...