mercoledì, 12 agosto 2026

Notizie AIOM – anno XVI n. 701

4 Dicembre 2018

Revised guideline to assess risk of human medicines for the environment

November 30, 2018 - EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders are invited to send their comments by 30 June 2019 to era_dg@ema.europa.eu using the Microsoft ...
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3 Dicembre 2018

Compromising Patient Protections to Lower Drug Costs Could Harm People with Cancer

November 27, 2018 - “While ASCO supports efforts to control drug prices, we are keenly aware that optimal cancer care requires patient access to the most medically appropriate drug, at the most opportune time, based on the highest quality evidence. Therefore, ASCO ...
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3 Dicembre 2018

FDA Approves First Biosimilar for Non-Hodgkin Lymphoma

November 28, 2018 - The FDA has approved the first rituximab biosimilar, CT-P10 (rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy. This is the first biosimilar ...
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3 Dicembre 2018

Brigatinib Approved in Europe for ALK+ NSCLC

November 27, 2018 - The European Commission has approved brigatinib for the treatment of adult patients with ALK-positive non–small cell lung cancer (NSCLC) who were previously treated with crizotinib, according to Takeda Pharmaceutical Company, the developer of the ...
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3 Dicembre 2018

Pegfilgrastim Biosimilar Approved in Europe

November 27, 2018 - The European Commission has granted approval to the biosimilar LA-EP2006, a biosimilar for pegfilgrastim, as a treatment to reduce the duration of neutropenia and incidence of febrile neutropenia that is associated with anticancer chemotherapy, according ...
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3 Dicembre 2018

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

November 29, 2018 - In November 2018, the US Food and Drug Administration (FDA) confirmed the capability of five additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Belgium, Denmark, Finland ...
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3 Dicembre 2018

A Subset of Mesotheliomas With Improved Survival Occurring in Carriers of BAP1 and Other Germline Mutations

We hypothesized that four criteria could help identify malignant mesotheliomas (MMs) most likely linked to germline mutations of BAP1 or of other genes: family history of MM, BAP1-associated cancers, or multiple malignancies; or age younger than 50 years. Over the course ...
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3 Dicembre 2018

BRCA Reversion Mutations in Circulating Tumor DNA Predict Primary and Acquired Resistance to the PARP Inhibitor Rucaparib in High-Grade Ovarian Carcinoma

A key resistance mechanism to platinum-based chemotherapies and PARP inhibitors in BRCA-mutant cancers is the acquisition of BRCA reversion mutations that restore protein function. To estimate the prevalence of BRCA reversion mutations in high-gradeovarian carcinoma (HGOC), ...
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3 Dicembre 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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3 Dicembre 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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