By sonia ziouani ammor In Events Tagged Adaptive Pathways, Clinical Trials, Drug Development, Early Access, Early dialogue, EMA, Europe, MHRA, Patient Access, PIM, PRIME, regulatory affairs
With the increasing acknowledgement of the need to develop an overarching scheme to enhance support for sponsors developing medicines, tackling unmet medical needs to ensure timely access to beneficial therapies, the EMA launched the PRIME scheme in March 2016. This
By sonia ziouani ammor In Events Tagged Adcetris, ALXN1210, ASH, CAR-T cell, Clinical Trials, Crizanlizumab, CTL019, Glasdegib, Hematology, Highlights, IASLC, Ibrutinib, KTE-C19, Lenalidomide, Obinutuzumab, Oncology, SABCS, WCLC
ASH 2016 Highlights, December 3-6 2016AbbVie Inc. & Janssen – Ibrutinib (IMBRUVICA®). PCYC-1121-CA Phase II trial assessed ibrutinib as a single-agent treatment for marginal zone lymphoma patients that received one or more prior therapies including at least one CD20-directed regimen. In the study, 79% of
