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

Settlement clears path for Biogen, Samsung’s Humira biosimilar

Settlement clears path for Biogen, Samsung’s Humira biosimilar

The three companies have reached a settlement in patent litigation that sets out definitive launch dates for the new Imraldi biosimilar, which was approved by the EMA last August, on both

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  • 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

  • Brexit Means Brexit Brexit Means Brexit

    The Prime Minister specifically cited the importance of regulatory alignment for the pharmaceutical industry, indicating a determination to explore how the UK can remain a member of the EMA. ... At the headline level it seems the EMA is encouraging

  • Deal Watch January 2018

    Ablynx submitted its MAA to the EMA for approval of caplacizumab in February last year and, according to Reuters, Ablynx has forecast peak caplacizumab sales of 1.2bn. ... GSK's malarial vaccine, Mosquirix which also contains Agenus’QS-21 Stimulon, was

  • Accelerating innovation Accelerating innovation

    While the company waits to hear from the EMA, there is also work underway to explore the use of Ipsen’s tyrosine-kinase inhibitor (TKI) Cabometyx in combination with some of

  • Avoiding data pitfalls in clinical research Avoiding data pitfalls in clinical research

    EMA guidance in recent years has touched on the role of genetics in pharmacovigilance and the importance of being able to identify patient populations with increased sensitivity to medicines. ... Clinical research sponsors need a comprehensive data

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