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
Join top regulators, clinical, safety, and research professionals in health care and drug development. Discuss the biggest challenges, gain new, invaluable insights, and leave inspired to take action. The DIA EuroMeeting goal is to bring together key healthcare stakeholder
By sonia ziouani ammor In Kinesys News Tagged CTCL, Drug Development, Early Access, Early dialogue, MHRA, Oncology, Orphan Drug, Patient Access, PIM, Real-World Evidence, regulatory affairs
Kinesys Consulting last month secured another PIM designation, this time for a new oncology product, on behalf of a US partner. The product, successfully designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for the treatment of
Kinesys Consulting has secured its first PIM designation, for a novel oncology supportive care product, on behalf of a US partner. The product, designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for
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
