Notizie AIOM – anno XVII – Pagina 82

19 Febbraio 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

February 15, 2019 - EMA’s safety committee (PRAC) has started a review of the risk of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances) with fenspiride medicines. Fenspiride is ...
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14 Febbraio 2019

FDA Grants Pembrolizumab Priority Review for Frontline HNSCC

February 11, 2019 - The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for pembrolizumab alone or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy as a first-line treatment for patients with recurrent ...
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14 Febbraio 2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use

February 11, 2019 - Today, the U.S. Centers for Disease Control and Prevention (CDC) released additional data from our joint FDA/CDC 2018 National Youth Tobacco Survey. These data are a sobering reminder of the initial results we shared last fall indicating a rampant rise ...
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14 Febbraio 2019

FDA Grants Avelumab/Axitinib Combo Priority Review for RCC

February 12, 2019 - The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for the combination of avelumab and axitinib as a treatment for patients with advanced renal cell carcinoma (RCC). The decision is based on findings ...
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14 Febbraio 2019

Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

February 13, 2019 - Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. One of the fundamental elements of overseeing the quality and safety of pharmaceuticals is having a clear understanding of the specific processes ...
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14 Febbraio 2019

Brentuximab Vedotin Approved in Europe for Frontline CD30+ Hodgkin Lymphoma

February 11, 2019 - The European Commission has approved brentuximab vedotin for use in combination with chemotherapy as a frontline treatment for adult patients with CD30+ stage IV Hodgkin lymphoma. The approval is based on findings from the phase III ECHELON-1 trial, which ...
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14 Febbraio 2019

New online platform for parallel distribution

February 11, 2019 - EMA has launched a secure online platform for submitting and managing parallel distribution notifications through the recently implemented IRIS Regulatory & Scientific Information Management Platform. Starting today, 11 February, parallel distributors ...
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14 Febbraio 2019

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

February 11, 2019 - In February 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). Poland and ...
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14 Febbraio 2019

The IMPACT study: early loss of skeletal muscle mass in advanced pancreatic cancer patients

Pancreatic cancer (PC) patients have multiple risk factors for sarcopenia and loss of skeletal muscle mass (LSMM), which may cause greater treatment toxicities, reduced response to cancer therapy, prolonged hospitalization, impaired quality of life, and worse prognosis. ...
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14 Febbraio 2019

Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028

To evaluate safety, tolerability, and antitumor activity of pembrolizumab monotherapy in patients with programmed death ligand 1 (PD-L1)-expressing advanced ovarian cancer enrolled in the multicohort, phase Ib KEYNOTE-028 trial. Key inclusion criteria were age ≥18 years; ...
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LAVORIAMO CON

News

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 XVII

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

FDA Grants Pembrolizumab Priority Review for Frontline HNSCC

Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use

FDA Grants Avelumab/Axitinib Combo Priority Review for RCC

Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs

Brentuximab Vedotin Approved in Europe for Frontline CD30+ Hodgkin Lymphoma

New online platform for parallel distribution

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

The IMPACT study: early loss of skeletal muscle mass in advanced pancreatic cancer patients

Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028