lunedì, 14 settembre 2026

Notizie AIOM – anno XVI n. 695

19 Ottobre 2018

FDA Grants Priority Review to Ibrutinib Plus Obinutuzumab in Frontline CLL

October 17, 2018 - The FDA has granted a priority designation to a supplemental new drug application (sNDA) for ibrutinib for use in combination with obinutuzumab for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma ...
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19 Ottobre 2018

Sales of antibiotics for use in food-producing animals drop across the EU

October 15, 2018 - A report published today by the European Medicines Agency (EMA) shows that the overall sales of veterinary antimicrobials across Europe have decreased by more than 20% between 2011 and 2016. This continues the downward trend seen over the last few years ...
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19 Ottobre 2018

Shaping regulatory science to 2025

October 17, 2018 - EMA is hosting a workshop on Wednesday, 24 October to gather insight from stakeholders on the key areas in human medicines to be covered in its ‘Regulatory Science Strategy to 2025’, a proposed new high-level plan for advancing its engagement ...
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19 Ottobre 2018

Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018

October 18, 2018 - Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 1.7% as of 18 October 2018, to reflect the inflation rate adjustments of 2017. All applications received by or having a data lock ...
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19 Ottobre 2018

INfluenza Vaccine Indication During therapy with Immune checkpoint inhibitors: a transversal challenge. The INVIDIa study

Considering the unmet need for the counseling of cancer patients treated with immune checkpoint inhibitors (CKI) about influenza vaccination, an explorative study was planned to assess flu vaccine efficacy in this population. INVIDIa was a retrospective, multicenter study, ...
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19 Ottobre 2018

Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer

Standard first-line therapy for metastatic, squamous non–small-cell lung cancer (NSCLC) is platinum-based chemotherapy or pembrolizumab (for patients with programmed death ligand 1 expression on ≥50% of tumor cells). More recently, pembrolizumab plus chemotherapy ...
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19 Ottobre 2018

Scheda informativa condivisa da ISS, PMA, AIMAC e AIOM

Suggerimenti semplici su come preservare la fertilità prima dei trattamenti antitumorali, cofirmati da Istituto Superiore di Sanità (ISS), Registro Nazionale di Procreazione Medicalmente Assistita (PMA), Associazione Italiana Malati di Cancro, parenti e amici ...
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19 Ottobre 2018

Dal Soroptimist International Club Genova a favore delle ragazze STEM

Il Premio, del valore di 2.000 Euro, sarà attribuito ad una Tesi di Laurea Magistrale in campo Emato-Oncologico, discussa da una studentessa dell’Università degli Studi di Genova negli anni accademici 2016-17 o 2017-18, in una delle seguenti discipline: ...
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19 Ottobre 2018

Deficiencies in health-related quality of life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016

Quality of life (QoL) is a relevant endpoint and a topic of growing interest by both scientific community and regulatory authorities. Our aim was to review QoL prevalence as an endpoint in cancer phase III trials published in major journals and to evaluate QoL reporting ...
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19 Ottobre 2018

15 ottobre 2018 – EMA raccomanda un nuovo medicinale per una serie di infezioni