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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.

Mundipharma adds breast cancer biosimilar to its portfolio with Celltrion deal

Mundipharma adds breast cancer biosimilar to its portfolio with Celltrion deal

As per terms of the deal, Mundipharma - a global network of privately owned independent companies - has acquired distribution and marketing rights in seven European countries for Herzuma (trastuzumab), a biosimilar of ... The biosimilar was granted

Latest news

  • NICE reverses its rejection of Eisai’s Lenvima NICE reverses its rejection of Eisai’s Lenvima

    This particular subset of patients in Scotland and Wales can already access Eisai’s medicine due to approvals from the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy. ... The positive recommendation comes three years after the

  • EMA set to review Teva’s migraine injection EMA set to review Teva’s migraine injection

    The European Medicines Agency (EMA) has accepted Teva’s marketing authorisation application (MAA) for its migraine prevention medicine fremanezumab.

  • EMA’s Amsterdam home will not be ready in time EMA’s Amsterdam home will not be ready in time

    The European Medicines Agency’s relocation from the UK to the Netherlands is being complicated by a need to move into temporary accommodation in the first instance. ... Of course, questions still remain about the role of the UK Medicines and Healthcare

  • EMA hands UniQure orphan status first in Huntington's EMA hands UniQure orphan status first in Huntington's

    The European Medicines Agency (EMA) has granted UniQure’s investigational gene therapy an orphan medicinal product designation (OMPD). ... European Union of no more than 5 in 10, 000.

  • Novo Nordisk makes improved €2.6bn offer for Ablynx Novo Nordisk makes improved €2.6bn offer for Ablynx

    The medicine in question - which received an orphan drug designation in Europe and the US - was submitted to the European Medicines Agency (EMA) back in February last year, and is currently ... awaiting a decision from the European regulatory body.

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Latest Intelligence

  • Drug R&D

    Healthcare terms - Drug R&D.

  • The tipping point The tipping point

    The second factor is the exponential increase in biosimilar approvals. In 2016/17, the European Medicines Agency approved around 20 biosimilars - that’s as many as were approved in the preceding ... is director of the biosimilar medical education

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

    The European Medicines Agency released draft guidance last year to offer new thinking on how the industry can incorporate genetic factors into understanding disease and therapeutic response. ... EMA guidance in recent years has touched on the role of

  • Building a bright future Building a bright future

    Herceptin while taking a buffeting over trading in the US, despite European growth contributing strongly to $2.96bn second quarter revenues. ... The European Commission and European Medicines Agency should have a role in encouraging faster work from

  • Brexit implications for UK pharma legislation Brexit implications for UK pharma legislation

    For pharmaceuticals, it will be impossible to simply ‘copy and paste’EU medicines law into UK law because EU law so heavily references the European Medicines Agency (EMA) and a ... Given that the UK’s medicines agency, the Medicines and Healthcare

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Latest appointments

  • Emotive grows medical writing capacity Emotive grows medical writing capacity

    Emotive grows medical writing capacity. Dr Silvana Bardelli and Dr Ann Gilliat join the agency. ... Dr Silvana Bardelli (pictured right) joins as a senior medical writer following a five year career at the Italian Medicines Agency serving as its young

  • 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

  • EMA appoints Luc Vanheel as head of administration EMA appoints Luc Vanheel as head of administration

    The European Medicines Agency (EMA) has named Luc Vanheel as the new head of its administration division. ... Vanheel has previously worked as finance and business services director and deputy director and head of plans and programmes at the European

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Latest from PMHub

  • Getting ready for the Identification of Medicinal Products

    Europe will be the first region to implement IDMP standards; the European Medicines Agency (EMA) will publish the full implementation guidelines for IDMP in 2015, leaving those who wait little time

  • Brexit and Pharma: A match made in hell.

    The demand for efficiency and expediency won out when the European Medicines Agency (EMA), a decentralized agency of the EU, began operating in 1995 from its base in London. ... 1. European Federation of Pharmaceutical Industries and Associations. The

  • The Heart of the Matter 7: Reality Dawns

    Likewise, European pharmacovigilance legislation implemented in 2012 means the European Medicines Agency (EMA) is now requesting post-marketing observational studies as part of its approval processes. ... In tandem, as the limitations of the 'gold

  • The Heart of the Matter 7: Reality Dawns

    Likewise, European pharmacovigilance legislation implemented in 2012 means the European Medicines Agency (EMA) is now requesting post-marketing observational studies as part of its approval processes. ... In tandem, as the limitations of the 'gold

  • A forward march for adaptive designs

    Very recently the European Medicines Agency (EMA) issued a qualification opinion on a novel statistical methodology for dose finding trials which employs adaptive modelling to optimise the analysis of dose-response ... Also late last year, the Center for

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