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RSS FeedPosted by Michael Wonder on 03 Aug 2021
Mustang Bio receives European Medicines Agency PRIME designation for MB-107 to treat X-linked severe combined immunodeficiency in newly diagnosed infants
2 August 2021 - Mustang Bio today announced that the EMA has granted Priority Medicines designation to MB-107, its lentiviral ...
Posted by Michael Wonder on 26 Apr 2021
Vertex and CRISPR Therapeutics announce Priority Medicines (PRIME) designation granted by the European Medicines Agency to CTX001 for transfusion-dependent beta thalassaemia
26 April 2021 - Vertex Pharmaceuticals and CRISPR Therapeutics today announced the EMA has granted Priority Medicines (PRIME) designation to ...
Posted by Michael Wonder on 03 Apr 2021
Autolus Therapeutics receives PRIME designation for AUTO1 for the treatment of adult ALL
1 April 2021 - Autolus Therapeutics today announced that it has received PRIority MEdicines (PRIME) designation from the EMA for AUTO1, ...
Posted by Michael Wonder on 29 Mar 2021
Rocket Pharmaceuticals receives EMA Priority Medicines (PRIME) designation for RP-L201 gene therapy for treatment of leukocyte adhesion deficiency-I
29 March 2021 - LAD-I program now holds all available accelerated regulatory designations in the U.S. and EU. ...
Posted by Michael Wonder on 26 Mar 2021
EMA validates marketing authorisation application for sacituzumab govitecan-hziy for the treatment of metastatic triple negative breast cancer
25 March 2021 - Agency grants accelerated assessment based on positive results of Phase 3 ASCENT trial. ...
Posted by Michael Wonder on 04 Feb 2021
Aruvant announces the EMA granted PRIME designation to ARU-1801 for the treatment of sickle cell disease
3 February 2021 - Aruvant Sciences today announced that the EMA granted PRIME designation to ARU-1801, a one-time investigational gene therapy ...
Posted by Michael Wonder on 02 Feb 2021
Janssen announces CAR-T therapy ciltacabtagene autoleucel (cilta-cel) accepted for accelerated assessment in Europe for the treatment of patients with heavily pretreated multiple myeloma
1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...
Posted 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 ...