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EMA

This page shows the latest EMA news and features for those working in and with pharma, biotech and healthcare.

New chair for Europe’s key medicines committee

New chair for Europe’s key medicines committee

Like other major regulators, such as the US FDA, the EMA is updating its structures and review processes as new technologies such as gene and cell therapy emerge from industry pipelines. ... The CHMP has just recommended Luxturna, Spark's gene therapy,

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  • The European Medicines Agency: PRIME’d for access? The European Medicines Agency: PRIME’d for access?

    The European Medicines Agency (EMA) is no different offering five routes that can hasten approval, under certain conditions. ... n = 36. Figure 2: Acceptance rates by therapeutic area. Source: Analysis using EMA data.

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... He says Bluebird found the EMA more engaged, and clinical sites were willing

  • Protecting patient privacy Protecting patient privacy

    is left to chance. Stay focused. Undoubtedly, the demands of EMA Policy 0070 are considerable. ... is EMA policy 0070 regulation and compliance expert at Kinapse. 3rd June 2018.

  • The NHS and ABPI at 70: inching closer to the triple win The NHS and ABPI at 70: inching closer to the triple win

    Mike Thompson told a Parliamentary committee last year he could see no upsides to Brexit: losing EMA membership, EU research funding and diminished access to scientific talent, and relegation as a

  • Uncertainty, austerity and Brexit Uncertainty, austerity and Brexit

    or where clinical trials are placed. Recognising the potentially negative consequences, the UK Government has moved away from its hard-line position on the EMA and now seems keen to remain

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  • The gene therapy revolution

    As an example, in the case of Strimvelis (autologous CD34. cells transduced to express adenosine deaminase [ADA]), the first ex vivo stem cell gene therapy approved by the EMA (European Medicines

  • Raising Awareness: Rare Disease Day

    Available at: . Last accessed: February 2017. 3.EMA. Orphan designation. Available at: Last accessed: February 2017.

  • Brexit and Pharma: A match made in hell.

    More than 600 full-time staff currently deliver this service in London, but many people are now asking whether the EMA has been made homeless. ... The EMA is just one example of the huge changes required in this whole adaptation process.

  • Wordbird tops the leader chart at the OTC awards

    Wordbird worked with HRA Pharma on the centralised EU switch of ellaOne from prescription to pharmacy, developing promotional materials for women and pharmacists as part of the EMA submission.

  • Life at the end of the Brexit tunnel

    We know that the EMA will be moving to mainland Europe, though we don't know the destination.

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