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RSS FeedPosted by Michael Wonder on 19 Jan 2021
Tessa Therapeutics receives PRIME designation from European Medicines Agency for CD30 CAR-T therapy
18 January 2021 - Tessa Therapeutics today announced that the EMA has granted PRiority MEdicines (PRIME) designation to the company's lead ...
Posted by Michael Wonder on 14 Dec 2020
ExCellThera receives Priority Medicines (PRIME) designation from European Medicines Agency for ECT-001 cell therapy
11 December 2020 - ExCellThera announced today that ECT-001 cell therapy has been granted PRIority MEdicines (PRIME) designation by the EMA ...
Posted by Michael Wonder on 15 Nov 2020
Insmed receives Priority Medicines (PRIME) designation from EMA for brensocatib in patients with non-cystic fibrosis bronchiectasis
13 November 2020 - Insmed today announced that the EMA has granted Priority Medicines (PRIME) designation to brensocatib for the ...
Posted by Michael Wonder on 08 Oct 2020
Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
7 October 2020 - The investigators of the study set out to characterise the therapeutic value of new drugs approved ...
Posted by Michael Wonder on 28 Sep 2020
Orchard Therapeutics receives EMA PRIME designation for OTL-203 for the treatment of MPS-I
28 September 2020 - Orchard Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) designation to OTL-203, an investigational ...
Posted by Michael Wonder on 25 Sep 2020
CRISPR Therapeutics and Vertex Pharmaceuticals announce Priority Medicines (PRIME) designation granted by the EMA to CTX001 for the treatment of sickle cell disease
24 September 2020 - CRISPR Therapeutics and Vertex Pharmaceuticals today announced the EMA has granted Priority Medicines (PRIME) designation to ...
Posted by Michael Wonder on 24 Sep 2020
bluebird bio’s LentiGlobin for sickle cell disease gene therapy (bb1111) granted priority medicines (PRIME) designation by European Medicines Agency
23 September 2020 - EMA’s PRIME program designed to optimise development and expedite evaluation of innovative medicines for patients with high ...
Posted by Michael Wonder on 30 Jul 2020
Imago BioSciences granted access by European Medicines Agency to PRIME scheme for IMG-7289 (bomedemstat) in myelofibrosis
30 July 2020 - Access granted on positive primary analysis of the ongoing Phase 2 trial to evaluate the safety and ...
Posted 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. ...