lunedì, 4 maggio 2026

Notizie AIOM – anno XVII

NCCN Guidelines Gain Traction Around the Globe

March 4, 2019 - Global use of cancer management guidelines from the National Comprehensive Cancer Network (NCCN) has climbed rapidly in recent years. A release from the NCCN, whose members include 28 high-ranking academic cancer centers, indicated that downloads of the guidelines ...
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Panel Proposes Standards for Reporting Data From Immuno-Oncology Trials

March 6, 2019 - The standards for reporting findings from immunotherapy studies should reflect the unique efficacy and toxicity characteristics of this rapidily emerging modality, with detailed and transparent explanations of definitions, according to a panel of experts. ...
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FDA Commissioner Scott Gottlieb, MD, Resigns

March 6, 2019 - On March 5, 2019, Scott Gottlieb, MD, announced his resignation as Commissioner of the U.S. Food and Drug Administration (FDA), a post he began in 2017. Dr. Gottlieb’s resignation will be effective next month. In a resignation letter to Alex M. Azar ...
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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

March 7, 2019 - We’re at a critical point for the future of biosimilars in the U.S. Millions of American patients stand to benefit from increased utilization of these lower-cost, high-quality products. At the FDA, we’re committed to helping patients realize the ...
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Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

March 4, 2019 - As the number of children using e-cigarettes remains at epidemic levels, our enforcement work has been one cornerstone of our efforts to protect youth from the dangers of tobacco products. In recent months our vigorous enforcement efforts as part of the agency’s ...
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FDA Grants Fedratinib Priority Review for Myelofibrosis

March 5, 2019 - The FDA has granted a priority review designation to a new drug application (NDA) for fedratinib as a treatment for patients with myelofibrosis. The designation is based on results from the phase III JAKARTA2 and phase II JAKARTA-2 trials3, which evaluated ...
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EU Panel Backs Extended Pembrolizumab Dosing Schedule for Single-Agent Indications

March 4, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a new extended dosing schedule for pembrolizumab for all of the PD-1 inhibitor’s monotherapy indications in the European Union. ...
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1 marzo 2019 – Monitoraggio della Spesa Farmaceutica Nazionale e Regionale (gennaio / ottobre 2018)

Change of time zone due to EMA’s relocation in March 2019

March 1, 2019 - EMA leaves its London premises on 1 March 2019 and relocate to Amsterdam, the Netherlands. During EMA's period of reduced virtual presence from 4 March to 8 March inclusive, EMA's working hours will continue to follow Greenwich Mean Time (GMT). From 11 March ...
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019

March 1, 2019 - EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including two orphan medicines1, at its February 2019 meeting. For three of the eight new medicines the CHMP recommended a conditional marketing authorisation. This was ...
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