Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)

31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...

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Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy application

20 November 2018 - EMA and the US FDA are organising a workshop on 26 November 2018 to discuss how ...

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FDA and EMA to hold workshop on breakthrough therapy and PRIME designations

2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...

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Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma

16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...

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Juno Therapeutics' and Celgene Corporation's investigational drug JCAR017 granted breakthrough therapy designation from FDA and priority medicines eligibility from EMA for relapsed/refractory diffuse large B cell lymphoma

20 December 2016 - Early results recently announced with JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia. ...

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Merck receives breakthrough therapy designation from FDA and PRIME status from EMA for investigational Ebola Zaire vaccine (V920)

25 July 2016 - Merck today announced two regulatory milestones for the company’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live ...

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