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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.

Vertex scores FDA approval for CF triple therapy Trikafta

Vertex scores FDA approval for CF triple therapy Trikafta

Vertex has also submitted the triple therapy to the European Medicines Agency, with a decision expected in 2020. ... With the subsequent rows over Vertex’s new medicines, it looks likely that these will also extend to the triple therapy.

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  • 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

  • The evolution of real-world studies The evolution of real-world studies

    The European Medicines Agency has shown a willingness to consider data from outside RCTs, noting in 2018 guidance on factor VIII products that changes to the patient population have made it ... The UK has high hopes for the study, which the Medicines

  • Bluebird: on a mission to ‘recode’ the DNA of healthcare Bluebird: on a mission to ‘recode’ the DNA of healthcare

    The European Medicines Agency’s CHMP committee recommended conditional marketing authorisation for Zynteglo (autologous CD34+ cells encoding β A-T87Q-globin gene) at the end of March, setting it up for ... All the European countries are testing

  • From lay summaries to patient engagement programmes: how patient-centricity is finally becoming a reality From lay summaries to patient engagement programmes: how patient-centricity is finally becoming a reality

    How pharma is progressing their commitment in patient engagement. In 2014, the European Medicines Agency (EMA) gave the first indication that layperson summaries of the results of pharma-sponsored clinical trials ... results. The European Meeting of

  • Drug launches to watch in 2019 Drug launches to watch in 2019

    In Europe, the company expects to file with the European Medicines Agency (EMA) in the first half of 2019. ... The company is rapidly establishing a European corporate infrastructure, led by Chief Operating Officer Chris Tovey, who is hiring staff in

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Latest appointments

  • 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

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

    He joins with immediate effect. 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

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Latest from PMHub

  • World Ovarian Cancer Day: Current treatments and future hopes for ovarian cancer

    10.          European Medicines Agency. Lynparza. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza. Accessed April 2019. 11.          European Medicines Agency. ... Zejula. Available at:

  • Solaris Health looks at the gene therapy revolution

    As an example, in the case of Strimvelis (autologous CD34. cells transduced to express adenosine deaminase [ADA]), the first ex vivo stem cell gene therapy approved by the EMA (European Medicines ... and the Italian Medicines Agency, known as AIFA,

  • 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

  • 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

  • Clinical data Transparency

    Amidst extensive criticism the pharmaceutical industry has called for more carrot as an incentive for companies to begin releasing their data; and in the face of two lawsuits even the European ... Medicines Agency (EMA) has had to defend its position on

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