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EMA

This page shows the latest EMA 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

  • Gut instincts lead Takeda to GI pipeline success Gut instincts lead Takeda to GI pipeline success

    The recent EMA approval of the subcutaneous formulation of its Inflammatory Bowel Disease (IBD) drug Entyvio was another milestone, as well as an important boost for patients. ... It has been a game changer for IBD patients and the EMA decision means

  • The search for treatments for Parkinson’s disease The search for treatments for Parkinson’s disease

    We have to work with the FDA and EMA to find more appropriate ways to do tests to get these drugs approved. ... The regulators haven’t yet gotten around to saying exactly what kind of results from wearable data they will consider, but you get the

  • The impact of COVID-19 on clinical trials The impact of COVID-19 on clinical trials

    Managing the impact of COVID-19 in the near term. The FDA, EMA and several national-level European governments have all issued guidance on conducting clinical trials during the pandemic, recognising ... Consistent with guidance from the FDA and EMA,

  • Biopharma and orphan drugs Biopharma and orphan drugs

    Nevertheless, the consensus is that EMA and FDA programmes designed to encourage biopharma to develop medicines for smaller patient populations – primarily the orphan designation – are working. ... Now there are over 160 orphan medicinal products

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

    COVID-19: managing clinical trials during the pandemic. EMA and FDA provide guidance as impact of virus intensifies. ... The EMA has acknowledged the impact the pandemic may have on clinical trails and trial participants.

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Latest appointments

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

    EMA gains a new executive director, Gilead appoints a new senior vice president and BeiGene hires a new chief business exec. ... European Medicines Agency (EMA). The European Medicines Agency (EMA) management board has nominated Emer Cooke (pictured above

  • New faces at Synergy Vision, Makara Health and JPA Health New faces at Synergy Vision, Makara Health and JPA Health

    regional health communications campaigns. In her new role, she will leverage her expertise in FDA/EMA communications, patient and physician education, scientific communications, issues management and celebrity engagement to serve JPA

  • NDA Group appoints Alison McGregor as its principal consultant NDA Group appoints Alison McGregor as its principal consultant

    Johan Stromquist, chief executive officer, NDA Group, said: “The US expansion is our main focus in 2018 and we are planning expanding our support for FDA and EMA submissions, milestone meetings

  • Dr Paula Salmikangas joins NDA Group Dr Paula Salmikangas joins NDA Group

    She is the former chair of the EMA’s Committee for Advanced Therapies and comes to NDA from the Finnish Medicines Agency, where she served as a research professor.

  • Dr Desiree Luthman joins Verona Pharma Dr Desiree Luthman joins Verona Pharma

    She has an accomplished track record of working closely with the FDA and EMA on behalf of international healthcare companies to achieve key regulatory milestones.

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Latest from PMHub

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COVID-19 Updates and Daily News

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