News

Revised EMA fee reductions for orphan drug sponsors

Revised EMA fee reductions for orphan drug sponsors

The European Medicines Agency’s policy on fee reductions for orphan medicinal products has been revised: from January 2014 non-SMEs sponsor gaining an ‘orphan drug’ designation will benefit of additional fee reductions. This should push the development and the...

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The AIFA medicinal products database is available online

The AIFA medicinal products database is available online

On 13th November 2013 the first certified database on medicinal products marketed in Italy has been released online and is available here. The Medicinal Products Database has been created by the Italian Medicine Agency (AIFA) and contains the Summary of Product...

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EMA addendum on antibacterial agents and resistance

EMA addendum on antibacterial agents and resistance

The European Medicines Agency (EMA) has released an Addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections. Among the key issues, this document outlines new approaches for the development of antibacterial...

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Paclitaxel-induced neuropathy: our research efforts

Paclitaxel-induced neuropathy: our research efforts

Fondazione Gianni Benzi has always addressed particular attention to the study of chronic neuropathies: besides supporting research projects with grants and scholarships, the Foundation sponsored a pilot study for the implementation of a Registry of Neuropathies and...

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Ethical challenges in DEEP clinical trials for thalassaemia

Ethical challenges in DEEP clinical trials for thalassaemia

Prof. Adriana Ceci, President of Fondazione Gianni Benzi, participated in the Thalassemia International Federation World Congress 2013, that has been held in Abu Dhabi from 20 to 23 October 2013, with a presentation entitled ‘A multi-ethnic multi-national approach to...

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