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European Medicines Agency

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

FDA sets January decision date for Xalkori in ALK-positive lymphoma

FDA sets January decision date for Xalkori in ALK-positive lymphoma

In addition to the FDA priority review, the European Medicines Agency (EMA) has agreed on a paediatric investigational plan for Xalkori, including the treatment of paediatric patients with relapsed or refractory

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Latest Intelligence

  • Guiding star of science leads AstraZeneca to breakthrough in child tumour therapy Guiding star of science leads AstraZeneca to breakthrough in child tumour therapy

    Selumetinib, taken as a twice-daily oral capsule, sparked huge interest when it was granted Orphan Drug Designation by the US FDA in February 2018 and by the European Medicines Agency

  • Developing a COVID-19 vaccine Developing a COVID-19 vaccine

    The European Medicines Agency (EMA) and The US Food and Drug Administration (FDA) have both provided guidance on how to manage clinical trials during the COVID-19 pandemic. ... The impact of the pandemic on European health systems and more broadly on

  • Novel endpoints in the digital age Novel endpoints in the digital age

    A European Medicines Agency spokesperson said: “Novel endpoints have the potential to be more precise and even more inclusive, meaning patients who would otherwise have been unwilling to enrol in a

  • Rethinking trials: the pros and cons of protocol amendments Rethinking trials: the pros and cons of protocol amendments

    The European Medicines Agency is not responsible for approving or overseeing the conduct of clinical trials, and therefore is not involved in clinical trial protocol amendments. ... However, when it comes to paediatric trials, the agency does get involved

  • Integrating patient reported outcomes into clinical trials Integrating patient reported outcomes into clinical trials

    How capturing the patient voice is unlocking medicines’ commercial potential. Patient-reported outcomes (PRO) are now critical to commercial success in many indications. . ... Regulators have sought to help sponsors work PROs into trials, for example

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Latest appointments

  • New hires at EMA, Gilead and BeiGene New hires at EMA, Gilead and BeiGene

    European Medicines Agency (EMA). The European Medicines Agency (EMA) management board has nominated Emer Cooke (pictured above) as its new executive director. ... Cooke worked for the pharmaceutical unit of the European Commission from 1998 to 2002, and

  • Emotive grows medical writing capacity Emotive grows medical writing capacity

    Dr Silvana Bardelli and Dr Ann Gilliat join the agency. Healthcare Communications agency Emotive has strengthened its medical writing team with the addition of two new hires. ... Dr Silvana Bardelli (pictured right) joins as a senior medical writer

  • Zelluna appoints Miguel Forte as CEO Zelluna appoints Miguel Forte as CEO

    Prior to his new role, Forte has held roles for Bone Therapeutics, TxCell, the European Medicines Agency, and  UCB to name a few.

  • Bone Therapeutics strengthens clinical development team Bone Therapeutics strengthens clinical development team

    His career to date has also seen him hold positions such as vice president, global medical affairs at UCB, as well as senior positions at the European Medicines agency, Bristol-Myers

  • EMA’s head of international affairs steps down EMA’s head of international affairs steps down

    The European Medicines Agency's (EMA) Emer Cooke has resigned as head of international affairs, to be replaced ad interim by Agnès Saint-Raymond. ... She has served as head of international affairs since 2013, and is leaving the agency to pursue a new

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