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RSS FeedPosted by Michael Wonder on 24 Oct 2022
European Medicines Agency grants PRIME designation to BIT Pharma’s NicaPlant for treatment of non-traumatic subarachnoid haemorrhage in patients undergoing surgery.
19 October 2022 - BIT Pharma today announced that the EMA has granted access to the Priority Medicines (PRIME) scheme for ...
Posted by Michael Wonder on 01 Aug 2022
Pharming receives accelerated assessment in Europe for leniolisib for the treatment of rare immunodeficiency, APDS
1 August 2022 - Pharming is on track to submit its marketing authorisation application for leniolisib in H2 2022. ...
Posted by Michael Wonder on 29 Jun 2022
Bavarian Nordic announces grant of PRIME eligibility from the EMA for its RSV vaccine candidate for the prevention of respiratory syncytial virus in older adults
28 June 2022 - Bavarian Nordic announced today that the EMA has granted access to its priority medicines (PRIME) scheme for ...
Posted by Michael Wonder on 28 Jun 2022
Adverum Biotechnologies granted Priority Medicines (PRIME) designation by EMA for ADVM-022 in wet AMD
24 June 2022 - Adverum Biotechnologies today announced that the EMA has granted ADVM-022 Priority Medicines (PRIME) designation for the treatment ...
Posted by Michael Wonder on 24 Jun 2022
BioNTech Receives Priority Medicines (PRIME) designation from EMA for enhanced regulatory support of CAR-T candidate BNT211 in testicular cancer
23 June 2022 - Designation follows positive interim Phase 1/2 data for BNT211 demonstrating an encouraging safety profile and early signs ...
Posted by Michael Wonder on 08 Jun 2022
Vertex announces inaxaplin (VX-147) granted breakthrough therapy designation by U.S. FDA and PRIME designation by the EMA
8 June 2022 - Vertex granted nine breakthrough therapy designations and three PRIME designations across its pipeline programs to date. ...
Posted by Michael Wonder on 27 Apr 2022
European Medicines Agency grants PRIME designation to BioCryst’s ALK-2 inhibitor, BCX9250, for treatment of fibrodysplasia ossificans progressiva
27 April 2022 - BCX9250 is first investigational drug for FOP to be eligible for program. ...
Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...
Posted by Michael Wonder on 15 Mar 2022
Drug industry says EMA’s PRIME scheme useful but could be improved
14 March 2022 - Eligibility criteria for admission to the EMA's priority medicines (PRIME) scheme are too strict to facilitate ...
Posted by Michael Wonder on 03 Mar 2022
PRIME enables earlier availability of life-changing medicines
3 March 2022 - EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that ...
Posted by Michael Wonder on 16 Dec 2021
CSL Behring receives accelerated CHMP assessment for etranacogene dezaparvovec for European patients living with haemophilia B
15 December 2021 - CSL Behring today announced that the CHMP, the chief scientific body of the EMA accepted its ...
Posted by Michael Wonder on 16 Nov 2021
CARsgen announces CAR T-cell product candidate CT041 granted PRIME eligibility by the EMA
15 November 2021 - CARsgen Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) eligibility to CT041 for the ...
Posted by Michael Wonder on 18 Oct 2021
EMA grants PRIME designation for JR-141 for the treatment of mucopolysaccharidosis type II (Hunter syndrome)
18 October 2021 - JCR Pharmaceuticals announced today that the EMA has granted PRIME designation for the investigational drug JR-141 (pabinafusp ...
Posted by Michael Wonder on 28 Sep 2021
European Medicines Agency grants Atara Biotherapeutics accelerated assessment of tab-cel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
27 September 2021 - Atara on track to submit MAA in November 2021. ...
Posted by Michael Wonder on 28 Aug 2021
European Medicines Agency grants Marinus Pharmaceuticals accelerated assessment of ganaxolone for treatment of CDKL5 deficiency disorder
26 August 2021 - Marinus Pharmaceuticals today announced that the CHMP of the EMA has granted its request for accelerated ...