venerdì, 16 ottobre 2026

Notizie AIOM – anno XVII n. 746

19 Novembre 2019

A first version of the Pan-European Indoor Radon Map

A hypothetical Pan-European Indoor Radon Map has been developed using summary statistics estimated from 1.2 million indoor radon samples. In this study we have used the arithmetic mean (AM) over grid cells of 10 km × 10 km to predict a mean indoor radon concentration ...
Leggi tutto

18 Novembre 2019

Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

November 15, 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant cells, ...
Leggi tutto

18 Novembre 2019

‘Regulatory science to 2025’: live broadcast of post-consultation workshop

November 11, 2019 - The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its draft ‘Regulatory Science Strategy to 2025’ on 18-19 November. The draft strategy sets out working proposals on the key areas with which ...
Leggi tutto

18 Novembre 2019

Dutch authorities hand over final building to EMA in Amsterdam

November 15, 2019 - Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in the Zuidas area of Amsterdam. Guido Rasi, EMA’s Executive Director, signed the lease agreement and thanked the Dutch authorities for reaching this ...
Leggi tutto

18 Novembre 2019

Adjuvant T-DM1 Approaches EU Approval for HER2+ Early Breast Cancer

November 15, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of trastuzumab emtansine (T-DM1) for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual ...
Leggi tutto

18 Novembre 2019

Lenalidomide/Rituximab Combo Nears EU Approval for Follicular Lymphoma

November 15, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the combination of lenalidomide and rituximab for the treatment of adult patients with grade 1 to 3a previously treated follicular lymphoma. The ...
Leggi tutto

18 Novembre 2019

EU Panel Backs Polatuzumab Vedotin Approval for DLBCL

November 15, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the antibody-drug conjugate (ADC) polatuzumab vedotin for use in combination with bendamustine and rituximab (BR) for the treatment ...
Leggi tutto

18 Novembre 2019

Fostamatinib Slated for EU Approval in Chronic ITP

November 15, 2019 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for a Marketing Authorization Application of fostamatinib disodium hexahydrate (fostamatinib) for the treatment of adult patients ...
Leggi tutto

15 Novembre 2019

FDA Grants Priority Review to Nivolumab/Ipilimumab in Advanced HCC

November 11, 2019 - The FDA has granted a priority review designation to a supplemental biologics license application for the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma (HCC) who received prior therapy with ...
Leggi tutto

15 Novembre 2019

Regulators’ advice can make a difference for faster patient access to highly innovative therapies

November 12, 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed to enable accelerated access of patients to highly innovative ...
Leggi tutto