Workshop on paediatric regulation – stakeholders to discuss how to boost development of medicines for children

19 March 2018 - Event to be broadcast live on 20 March. ...

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Europe follows FDA with plans to help early Alzheimer's drugs

28 February 2018 - European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans ...

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How to better apply the paediatric legislation to boost development of medicines for children

31 January 2018 - EMA and European Commission invite stakeholders to register for joint workshop and support development of an ...

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Competition in pharmaceuticals: more product- than price-oriented?

23 January 2018 - Competition is a subject always open to debate in health care, and pharmaceuticals are no exception, with ...

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EMA surveys pharma companies on their preparedness for Brexit

23 January 2018 - Planning of regulatory steps needed to ensure medicines remain on EU market. ...

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Towards a single development programme for new antibiotics in EU, Japan and US

17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...

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New action plan to foster development of advanced therapies

20 October 2017 - Actions address specific challenges identified by stakeholders. ...

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Is the NHS being held to ransom by big pharma?

7 October 2017 - Late last year Britain’s competition watchdog slapped a record £90m worth of fines on US drugs ...

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Drug makers' hopes for gene therapy rise despite tiny sales in Europe

8 August 2017 - The science of gene therapy is finally delivering on its potential, and drug makers are now ...

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EMA encourages tailored development of medicines for older people

1 August 2017 - EMA invites comments on reflection paper by 31 January 2018. ...

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Concept paper on development and lifecycle of personalised medicines and companion diagnostic

28 July 2017 - Public consultation to end on 31 October 2017. ...

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Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study

26 July 2017 - Goldacre et al. set out to identify the policies of major pharmaceutical companies on transparency of trials, ...

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EU watchdog concerned drug agency EMA may be too close to companies

19 July 2017 - The EMA, eager to accelerate access to promising new drugs, may be getting too cosy with ...

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Brexit must not disrupt drug R&D, say pharma chiefs

6 July 2017 - Industry lobbying began shortly after British referendum last June. ...

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Workshop: addressing unmet needs of children with pulmonary arterial hypertension

6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...

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