UK trailing Europe on access to cancer drugs

23 June 2016 - The UK is trailing Europe on cancer spend, survival rates and patient access to new oncology medicines, ...

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EMA and FDA reinforce collaboration on patient engagement

22 June 2016 - New working group established to exchange best practices. ...

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Santhera’s marketing authorization application for Raxone in Duchenne muscular dystrophy validated by the European Medicines Agency

21 June 2016 - Santhera Pharmaceuticals announces that the EMA has validated its marketing authorization application for Raxone (idebenone) for ...

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Agenda for June 2016 CHMP meeting

20 June 2016 - The agenda for the 20-23 June 2016 CHMP meeting is now available. ...

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EU Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States

17 June 2016 - The EU wants patients to have access to essential medicines. ...

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‘Brexit’ could relocate EU drug and banking agencies

20 June 2016 - The European Medicines Agency and European Banking Authority are both in London. ...

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EMA publishes list of applications for new human medicines under evaluation by the CHMP

16 June 2016 - This document lists information on applications for centralised marketing authorisation for human medicines that the EMA ...

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Roche’s Gazyvaro approved in Europe in combination with bendamustine for people with previously treated follicular lymphoma

16 June 2016 - This is the second approval in Europe for Gazyvaro based on a positive phase III study. ...

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EMA publishes EPAR for Neparvis (sacubitril with valsartan)

13 June 2016 - The EMA has published an EPAR for Novartis' second brand of sacubitril with valsartan. ...

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EMA celebrates ten years of its patients and consumers working party

10 June 2016 - Join the live broadcast on Tuesday, 14 June from 14:00 to 17:00. ...

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EMA publishes EPAR for Galafold (migalastat hydrochloride)

9 June 2016 - The EMA has published an EPAR for Amicus Therapeutics' Galafold (migalastat hydrochloride). ...

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EMA publishes EPAR for Flixabi (infliximab)

9 June 2016 - The EMA has published an EPAR for Samsung Bioepis' Flixabi (infliximab). ...

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EMA publishes EPAR for autologous CD34+ enriched cell fraction (Strimvelis)

8 June 2016 - The EMA has published an EPAR for autologous CD34+ enriched cell fraction that contains CD34+ cells transduced ...

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Roche receives EU approval of Avastin in combination with Tarceva for patients with a specific type of advanced lung cancer

8 June 2016 - This marks the first approval for Avastin in combination with another targeted therapy. ...

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EU agrees tighter standards for medical devices

1 June 2016 - The European Union has agreed major changes to its 20 year old regulatory framework for medical devices. ...

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