lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

TAS-102 Nabs Japanese Approval for Gastric Cancer

Aug 23, 2019 - The Japanese Ministry of Health, Labour and Welfare has approved TAS-102 (trifluridine/tipiracil) for the treatment of patients with unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy, according to Taiho Pharmaceutical ...
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EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

Aug 16, 2019 - EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. This is one of the findings of a joint EMA/FDA analysis comparing decisions on 107 new medicine applications at the two agencies ...
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FDA proposes new required health warnings with color images for cigarette packages and advertisements to promote greater public understanding of negative health consequences of smoking

Aug 15, 2019 - Today, the U.S. Food and Drug Administration issued a proposed rule to require new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The proposed warnings, which ...
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NCCN Guidelines Set New Pace for Pediatric ALL

Aug 4, 2019 - With the recent publication of an inaugural set of guidelines for treatment of pediatric acute lymphoblastic leukemia (ALL), the National Comprehensive Cancer Network (NCCN) seeks to introduce standards to a branch of care long dominated by clinical trial protocols. ...
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CAR T-Cell Therapy Coverage Decision Improves Medicare Beneficiary Access to Cancer Care

Aug 8, 2019 - “ASCO applauds the Centers for Medicare & Medicaid Services (CMS) for releasing a national coverage determination (NCD) on CAR T-cell therapy that provides increased access to an innovative cancer treatment to Medicare beneficiaries nationwide. The ...
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USPSTF Recommendation on Screening for Pancreatic Cancer in Asymptomatic Adults

Aug 13, 2019 - As reported in JAMA, the U.S. Preventive Services Task Force (USPSTF), in a reaffirmation of its 2004 recommendation, has recommended against screening for pancreatic cancer in asymptomatic adults (a grade D recommendation). In developing the current recommendation, ...
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NCORP Expands to More Sites

Aug 20, 2019 - The National Cancer Institute (NCI) has awarded 53 grants to researchers in the NCI Community Oncology Research Program (NCORP) to conduct multisite cancer clinical trials and cancer care delivery studies in their communities. In addition to seven research ...
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FDA Approves Darolutamide for Nonmetastatic CRPC

July 31, 2019 - The FDA has approved darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer. The approval of the androgen receptor inhibitor is based on data from the phase III ARAMIS trial, in which darolutamide in combination ...
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Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published

July 31, 2019 - EMA and the US Food and Drug Administration (FDA) have published today a report on their joint workshop with stakeholders held on 26 November 2018. The aim of this workshop was to discuss scientific and regulatory approaches to address quality and manufacturing ...
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30 luglio 2019 – AIFA pubblica Rapporto Vaccini 2018