Blog
RSS FeedPosted by Michael Wonder on 24 Jul 2020
Adaptimmune granted access to PRIority MEdicines (PRIME) regulatory support by the European Medicines Agency for ADP-A2M4 for the treatment of synovial sarcoma
23 July 2020 - Adaptimmune Therapeutics today announced that the EMA has granted access to the PRIME initiative to the ...
Posted by Michael Wonder on 06 Jul 2020
EMA validates and grants accelerated assessment for trastuzumab deruxtecan for the treatment of HER2 positive metastatic breast cancer
6 July 2020 - Daiichi Sankyo today announced that the EMA has validated the marketing authorisation application for trastuzumab deruxtecan, ...
Posted by Michael Wonder on 05 May 2020
Acceleron receives PRIME Designation from EMA for sotatercept in pulmonary arterial hypertension
4 May 2020 - PRIME designation comes just three weeks after US FDA granted sotatercept breakthrough therapy designation. ...
Posted by Michael Wonder on 03 Mar 2020
MeiraGTx announces Priority Medicines (PRIME) and Advanced Therapy Medicinal Product designations granted by the EMA to AAV-RPGR gene therapy for the treatment of X-linked retinitis pigmentosa
2 March 2020 - PRIME designation granted based on clinical data from ongoing Phase 1/2 trial of AAV-RPGR. ...
Posted by Michael Wonder on 24 Dec 2019
European Medicines Agency validates BioMarin's marketing authorisation application for valoctocogene roxaparvovec to treat severe haemophilia A
23 December 2019 - Potential first gene therapy in Europe directed at any type of haemophilia. ...
Posted by Michael Wonder on 17 Dec 2019
Rocket Pharmaceuticals receives EMA PRIME eligibility for RP-L102 gene therapy for Fanconi anaemia
16 December 2019 - Milestone gives Fanconi anaemia program all accelerated regulatory tools in U.S. and EU, including FDA regenerative medicine ...
Posted by Michael Wonder on 02 Dec 2019
Orchard Therapeutics announces the filing and validation of marketing authorisation application by EMA for OTL-200 for the treatment of metachromatic leukodystrophy
2 December 2019 - Application Being Evaluated Under Accelerated Assessment. ...
Posted by Michael Wonder on 19 Nov 2019
European Medicines Agency grants Orchard Therapeutics accelerated assessment of OTL-200 for patients with metachromatic leukodystrophy
18 November 2019 - Orchard Therapeutics today announced that the CHMP of the EMA has granted an accelerated assessment for OTL-200, ...
Posted by Michael Wonder on 10 Oct 2019
Emergent BioSolutions receives EMA Prime Designation for its Chikungunya virus vaccine candidate
10 October 2019 - Emergent BioSolutions today announced that the company’s chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, ...
Posted 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. ...