Notizie AIOM – anno XV – Pagina 6

4 Dicembre 2017

Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

December 1, 2017 - The European Medicines Agency (EMA) and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union (EU). Companies are reminded to plan in advance ...
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4 Dicembre 2017

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017

December 1, 2017 - PRAC starts two safety referrals and reaches conclusion on re-examination. PRAC issues warning about use of prostate cancer medicine Radium-223 dichloride in combination with Abiraterone acetate and prednisone or prednisolone. The PRAC has started an investigation ...
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1 Dicembre 2017

Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial

Adjuvant chemotherapy for resected early-stage non-small-cell lung cancer (NSCLC) provides a modest survival benefit. Bevacizumab, a monoclonal antibody directed against VEGF, improves outcomes when added to platinum-based chemotherapy in advanced-stage non-squamous NSCLC. ...
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1 Dicembre 2017

Procedural guidance to help pharma companies prepare for Brexit

November 28, 2017 - The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). The guidance document outlines the practical and simplified requirements ...
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1 Dicembre 2017

Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202

Adherence to aromatase inhibitor (AI) therapy for early-stage breast cancer is limited by AI-associated musculoskeletal symptoms (AIMSS). Duloxetine is US Food and Drug Administration approved for treatment of multiple chronic pain disorders. We hypothesized that treatment ...
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1 Dicembre 2017

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

November 30, 2017 - The U.S. Food and Drug Administration today approved buprenorphine, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal ...
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1 Dicembre 2017

EU Expert Group Releases Position Statement on Lung Cancer Screening in Europe

November 30, 2017 - As reported in The Lancet Oncology by Oudkerk et al, a European Union (EU) expert group has issued a position statement on low-dose computed tomography (CT) screening for lung cancer, proposing a near-term phased implementation of screening in high-risk ...
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1 Dicembre 2017

Luminal-like HER2-negative stage IA breast cancer: a multicenter retrospective study on long-term outcome with propensity score analysis

The benefit of adding chemotherapy (CT) to adjuvant hormone therapy (HT) in stage IA luminal-like HER2-negative breast cancer (BC) is unclear. We retrospectively evaluated predictive factors and clinical outcome of 1,222 patients from 4 oncologic centers. Three hundred and ...
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1 Dicembre 2017

Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer

Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients ...
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1 Dicembre 2017

27 novembre 2017 – Nota Informativa Importante su Midazolam

LAVORIAMO CON

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TUMORE AL SENO: METASTASI SI DIFFONDONO COME GOCCE SU UNA SUPERFICIE. LA CAPACITÀ INVASIVA DIPENDE DALLA “FLUIDITÀ” DEL CANCRO

ONE HEALTH FOUNDATION: AL VIA IL PROGETTO IN 36 CENTRI ESTIVI IN ALBANIA. SULLA “NAVE DELLA SALUTE” SVOLTI PIU’ DI 550 TEST E VISITE MEDICHE

AL VIA LA TERZA EDIZIONE DELLA “NAVE DELLA SALUTE” ITALIA-ALBANIA. LA PREVENZIONE SALE A BORDO CON 17 MEDICI SPECIALISTI E 10 AMBULATORI

TOVORAFENIB È LA PRIMA TERAPIA MIRATA APPROVATA IN EUROPA NEL GLIOMA PEDIATRICO DI BASSO GRADO RECIDIVATO O REFRATTARIO, INDIPENDENTEMENTE DAL TIPO DI ALTERAZIONE DI BRAF

TOZORAKIMAB HA SODDISFATTO L’ENDPOINT PRIMARIO DELLO STUDIO DI FASE III MIRANDA NEI PAZIENTI CON BPCO

MIASTENIA GRAVIS, 15MILA PERSONE COLPITE IN ITALIA. “UN’INSTALLAZIONE IMMERSIVA PER COMPRENDERE LA VITA DEI PAZIENTI E AUMENTARE LA CONSAPEVOLEZZA”

MELANOMA, IN ITALIA POSSONO ESSERE “EREDITARI” 2.600 CASI L’ANNO. IMI: “LA PREVENZIONE SIA ANCHE ESAMI GENETICI E SORVEGLIANZA CUTANEA”

Notizie AIOM – anno XV

Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017

Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial

Procedural guidance to help pharma companies prepare for Brexit

Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder

EU Expert Group Releases Position Statement on Lung Cancer Screening in Europe

Luminal-like HER2-negative stage IA breast cancer: a multicenter retrospective study on long-term outcome with propensity score analysis

Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer

27 novembre 2017 – Nota Informativa Importante su Midazolam