Acknowledgement for APICES collaboration in GREKO study published in «Clinical and Translational Oncology«

We want to share the acknowledgment that APICES has received in the recent publication titled “Open-label phase II clinical trial of ketoconazole as CYP17 inhibitor in metastatic or advanced non-resectable granulosa cell ovarian tumors: the GREKO (Granulosa Et Ketoconazole) trial, GETHI 2011-03”. published in Clinical and Translational Oncology in which APICES has collaborated in project…

Acknowledgement for APICES collaboration in DART 01/05 study published in «The Lancet Oncology»

Once more time we are privileged to share the acknowledgment that APICES has received in the recent publication titled: “High-dose radiotherapy and risk-adapted androgen deprivation in localized prostate cancer (DART 01/05): 10-year results of a phase 3 randomised, controlled trial”. This is an extra motivation for the whole APICES team. These achievements would not be…

Acknowledgement for APICES collaboration in FDO-LMA-2016-01 study published in «Medicine International»

This month, we want to share the acknowledgment that APICES has received in the recent publication titled “Biomarker-driven phase IB clinical trial of OPB-111077 in acute myeloid leukemia”, published in Medicine International in which APICES has collaborated in several tasks of the project as design, setup, coordination and project management, monitoring, statistical analysis and preparation of the manuscript. This…

Acknowledgment for APICES collaboration in a study published in Blood Cells, Molecules, and Diseases.

This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A decade of changes in management of immune thrombocytopenia, with special focus on elderly patients” published in Blood Cells, Molecules, and Diseases in which APICES has collaborated in several tasks of the project. This means an extra motivation…

Acknowledgment for APICES collaboration in STREAM study published in Clinical and Translational Oncology.

This month, we want to share the acknowledgment that APICES has received in a recent publication in Clinical and Translational Oncology in which APICES has collaborated in several tasks of the project. This means to all APICES team an extra motivation in order to give continuity to the implication we have in every project in…

EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES

EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing decisions on 107 new medicine applications at the…

Call for all sponsors to publish clinical trial results in EU database

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT). Transparency and public access to clinical trial results, whether positive or negative, are fundamental…