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paediatric medicines

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

EC approves Otsuka and Astex’s Inaqovi for acute myeloid leukaemia

EC approves Otsuka and Astex’s Inaqovi for acute myeloid leukaemia

In addition to the EC approval, the European Medicines Agency previously agreed to a paediatric investigation plan for the oral combination treatment, which the partners say represents “an important milestone for ... A paediatric investigation plan is

Latest news

  • EU’s 10-year paediatric meds report - not bad, but can do better EU’s 10-year paediatric meds report - not bad, but can do better

    Measures to promote the testing of medicines in paediatric patients have resulted in a significant reduction in the off-label use of adult medicines in children, says the European Commission. ... The MEP who was rapporteur for the Paediatric Regulation -

  • Clinical research in children lagging, says report Clinical research in children lagging, says report

    The report has been welcomed by the Institute of Cancer Research (ICR), which has been campaigning for a change to the 2007 EU Paediatric Regulation for some time. ... The Nuffield report also calls for incentives to be introduced for paediatric clinical

  • EMA and FDA create pharmacovigilance 'cluster' EMA and FDA create pharmacovigilance 'cluster'

    The development follows heightened efforts in medicines safety from the EMA, centred around the launch of new pharmacovigilance legislation in 2012. ... The new cluster builds on these efforts, and the EMA and FDA have experience in similar arrangements

  • EU rules 'deny cancer therapy to children' EU rules 'deny cancer therapy to children'

    Cancer groups demand change to loophole that allows drugs to be excluded from paediatric trials. ... Children with cancer in Europe are being denied access to potentially life-saving drugs because a loophole in EU law means that pharma companies can

  • EMA prepares for digital signature introduction EMA prepares for digital signature introduction

    From next month will accept digital signatures for certain procedures. The European Medicines Agency (EMA) will next month start to accept digitally signed documents for the first time. ... In a phased introduction, the regulator will begin with

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Latest appointments

  • EMA’s Paediatric Committee elects new leaders EMA’s Paediatric Committee elects new leaders

    The European Medicines Agency's (EMA) Paediatric Committee (PDCO) last week elected Dirk Mentzer and Henk van den Berg chair and vice-chair, respectively, at its September meeting. ... Dr Van den Berg is a consultant in paediatric haematology / oncology

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Latest from PMHub

  • Precision paediatrics: Treating patients with CAR-T

    Dr Stuart Adams specialises in using T-cell therapy to treat paediatric patients at Great Ormond Street Hospital. ... Dr Stuart Adams is among the scientists leading the quest to develop precision medicines for seriously ill paediatric patients.

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