Notizie AIOM – anno XVII – Pagina 61

3 Maggio 2019

FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway

April 30, 2019 - The U.S. Food and Drug Administration today announced it has authorized the marketing of new tobacco products manufactured by Philip Morris Products S.A. for the IQOS “Tobacco Heating System” – an electronic device that heats tobacco-filled ...
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3 Maggio 2019

EU Panel Backs Olaparib Approval for Frontline Maintenance in Ovarian Cancer

April 29, 2019 - The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of olaparib as a frontline maintenance treatment for patients with BRCA-mutant advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer ...
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3 Maggio 2019

Cemiplimab Nears EU Approval for CSCC

April 29, 2019 - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of cemiplimab for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma ...
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3 Maggio 2019

Two additional countries to benefit from EU-US mutual recognition agreement for inspections

April 30, 2019 - In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus ...
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29 Aprile 2019

New long-lasting implant to treat opioid dependence

April 26, 2019 - EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine ...
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29 Aprile 2019

Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial

The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative ...
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29 Aprile 2019

Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial

First-line pembrolizumab monotherapy improves overall and progression-free survival in patients with untreated metastatic non-small-cell lung cancer with a programmed death ligand 1 (PD-L1) tumour proportion score (TPS) of 50% or greater. We investigated overall survival ...
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29 Aprile 2019

Assessment of Health Care Utilization and Cost of Targeted Drug Delivery and Conventional Medical Management vs Conventional Medical Management Alone for Patients With Cancer-Related Pain

Targeted drug delivery (TDD) has potential for cost savings compared with conventional medical management (CMM). Despite positive clinical and economic evidence, TDD remains underused to treat cancer pain. To assess the cost of TDD and CMM in treating cancer-related pain. ...
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29 Aprile 2019

23 aprile 2019 – Nota Informativa Importante su Alemtuzumab (Genzyme)

29 Aprile 2019

24 aprile 2019 – Carenza fludrocortisone acetato – modalità di richiesta d’importazione dall’estero

LAVORIAMO CON

News

LA PREVENZIONE DEL MELANOMA: AL VIA UNA CAMPAGNA NEI COOP.FI

TUMORI: “AIFA APPROVA LA FORMULAZIONE SOTTOCUTANEA E TRE NUOVE INDICAZIONI TERAPEUTICHE DI NIVOLUMAB”

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

Notizie AIOM – anno XVII

FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway

EU Panel Backs Olaparib Approval for Frontline Maintenance in Ovarian Cancer

Cemiplimab Nears EU Approval for CSCC

Two additional countries to benefit from EU-US mutual recognition agreement for inspections

New long-lasting implant to treat opioid dependence

Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial

Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial

Assessment of Health Care Utilization and Cost of Targeted Drug Delivery and Conventional Medical Management vs Conventional Medical Management Alone for Patients With Cancer-Related Pain

23 aprile 2019 – Nota Informativa Importante su Alemtuzumab (Genzyme)

24 aprile 2019 – Carenza fludrocortisone acetato – modalità di richiesta d’importazione dall’estero