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RSS FeedPosted by Michael Wonder on 08 Mar 2023
Genethon given PRIME status by EMA for gene therapy to treat Crigler-Najjar syndrome, a rare liver disease
7 March 2023 - Genethon today announced that the EMA has granted PRIME (Priority Medicines) status to the gene therapy, ...
Posted by Michael Wonder on 21 Feb 2023
US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
21 February 2023 - US FDA has set an action date for August 2023. ...
Posted by Michael Wonder on 18 Jan 2023
Forge Biologics receives PRIME designation from the EMA for novel gene therapy FBX-101 for the treatment of patients with Krabbe disease
17 January 2023 - FBX-101 is granted priority medicines (PRIME) designation by the EMA after review of Phase 1/2 RESKUE clinical ...
Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
Posted by Michael Wonder on 09 Nov 2022
Study: high concordance in breakthrough therapy, PRIME decisions
8 November 2022 - The US FDA and the EMA agreed on nearly two-thirds of decisions to grant or deny ...
Posted by Michael Wonder on 28 Oct 2022
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment
28 October 2022 - Application based on positive pivotal Phase 3 data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract ...
Posted 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 ...