Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2024
GSK’s B7-H3 targeted antibody drug conjugate, GSK’227, receives EMA Priority Medicines (PRIME) designation in relapsed extensive-stage small-cell lung cancer
16 December 2024 - Regulatory designation based on promising preliminary clinical data. ...
Posted by Michael Wonder on 13 Dec 2024
Vir Biotechnology receives FDA breakthrough therapy designation and EMA PRIME designation for tobevibart and elebsiran in chronic hepatitis delta
12 December 2024 - Phase 3 ECLIPSE registrational program in chronic hepatitis delta to begin in the first half of 2025. ...
Posted by Michael Wonder on 30 Nov 2024
Nurix Therapeutics receives PRIME designation from the EMA for NX-5948 for the treatment of relapsed or refractory chronic lymphocytic leukaemia
20 November 2024 - Pivotal trials of NX-5948 are planned to initiate in 2025. ...
Posted by Michael Wonder on 01 Jul 2024
Sipavibart EMA regulatory submission accepted under accelerated assessment for COVID-19 prevention
1 July 2024 - Submission based on positive SUPERNOVA Phase 3 trial data which demonstrated a statistically significant reduction in ...
Posted by Michael Wonder on 26 Jun 2024
ExCellThera announces EMA’s acceptance under accelerated assessment of market authorisation application for UM171 cell therapy for patients with haematological malignancies who lack a readily available suitable donor
25 June 2024 - ExCellThera announced today that the market authorisation application for UM171 cell therapy (INN-dorocubicel) has been accepted under ...
Posted by Michael Wonder on 21 May 2024
Wugen announces RMAT and PRIME designations for WU-CART-007 to accelerate regulatory reviews
20 May 2024 - Researchers to present new Phase 2 data showing safety and anti-leukaemic activity with WU-CART-007 and additional new ...
Posted by Michael Wonder on 06 Feb 2024
Ultragenyx receives PRIME designation from EMA for GTX-102 for the treatment of Angelman syndrome
5 February 2024 - GTX-102 is the first Angelman syndrome therapeutic candidate to receive PRIME designation. ...
Posted by Michael Wonder on 27 Nov 2023
EMA accepts Valneva’s Chikungunya vaccine marketing authorisation application for accelerated assessment
27 November 2023 - Valneva today announced that the EMA has performed a technical validation of the marketing authorisation application ...
Posted by Michael Wonder on 23 Nov 2023
Praxis Precision Medicines receives PRIME designation from the EMA for elsunersen (PRAX-222) for treatment of SCN2A gain of function developmental epilepsies
16 November 2023 - IRE) -- Praxis Precision Medicines today announced that the EMA has awarded its Priority Medicines (PRIME) designation ...
Posted by Michael Wonder on 26 Oct 2023
Valneva submits Chikungunya vaccine marketing application to EMA and announces CHMP accelerated assessment
25 October 2023 - Valneva today announces the submission of a marketing application with the EMA for approval of the ...
Posted by Michael Wonder on 25 Oct 2023
Annexon receives PRIME designation from the EMA for ANX007 for the treatment of geographic atrophy
24 October 2023 - PRIME designation granted based on Phase 2 ARCHER trial results, which showed meaningful preservation of visual function ...
Posted by Michael Wonder on 24 Oct 2023
4DMT receives EMA Priority Medicines (PRIME) designation for 4D-150 clinical stage genetic medicine for treatment of wet AMD
23 October 2023 - 4D-150 combines a novel, targeted intravitreal next generation AAV vector with a dual transgene that inhibits four ...
Posted by Michael Wonder on 14 Oct 2023
Intellia Therapeutics receives Priority Medicines (PRIME) designation from the EMA for NTLA-2002, an investigational in vivo CRISPR genome editing treatment for hereditary angioedema
13 October 2023 - Intellia Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to NTLA-2002 for ...
Posted by Michael Wonder on 19 Sep 2023
Cellectar Biosciences receives European Medicines Agency Priority Medicines (PRIME) designation for iopofosine for Waldenstrom’s macroglobulinaemia
18 September 2023 - The EMA’s PRIME status is granted to drug candidates that may offer a major therapeutic advantage over ...
Posted by Michael Wonder on 01 Jun 2023
Rocket Pharmaceuticals receives EMA Priority Medicines (PRIME) designation for RP-A501 gene therapy for Danon disease
31 May 2023 - Rocket Pharmaceuticals today announced that the EMA has granted Priority Medicines (PRIME) designation to RP-A501, the ...