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Notizie Newsletter

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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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15 Novembre 2019

14 novembre 2019 – Aggiornamento EMA per le aziende sulle impurezze da nitrosammine

15 Novembre 2019

Growing Field of Cardio-Oncology Boosted by Collaboration Between Leading Oncology and Cardiovascular Health Organizations

November 14, 2019 - Providing researchers with access to real-world cancer patient data has the potential to improve care and impact quality of life for cardio-oncology patients everywhere. To accomplish this, two science-based organizations, CancerLinQ LLC, a nonprofit ...
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