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European Commission

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

Pfizer gets EU nod for Tagrisso rival Vizimpro

Pfizer gets EU nod for Tagrisso rival Vizimpro

Five year survival still only 12%. Pfizer’s Vizimpro, a drug that could challenge AstraZeneca’s fast-growing Tagrisso in lung cancer, has been approved for marketing by the European Commission.

Latest news

  • Bluebird gets European recommendation for gene therapy Zynteglo Bluebird gets European recommendation for gene therapy Zynteglo

    The European Medicines Agency’s CHMP committee has recommended conditional marketing authorisation for Zynteglo (autologous CD34+ cells encoding β A-T87Q-globin gene), setting it up for full European Commission approval ... We look forward to the

  • Bluebird plays down report of EU gene therapy approval Bluebird plays down report of EU gene therapy approval

    They say Zynteglo “is now approved for use in all European countries covered by the EMA”  for the treatment of adolescents and adults with transfusion-dependent beta-thalassaemia (TDT) who do ... not have a specific genetic profile, although full

  • Pharma fears “lack of focus” on no-deal Brexit preparations Pharma fears “lack of focus” on no-deal Brexit preparations

    Theresa May with European leaders yesterday in Brussels: Brexit is delayed, but no-deal remains a possibility. ... The blog also notes that the European Commission and European Medicines Agency have said that any action to resolve these issues is a

  • Sanofi gets cardio outcomes claim for Praluent in EU Sanofi gets cardio outcomes claim for Praluent in EU

    The European Commission cleared Praluent (alirocumab) to reduce cardiovascular risk in adults with established atherosclerotic cardiovascular disease (ASCVD), almost a year after Amgen got the green light to include its own

  • CHMP recommends new Keytruda dosing schedule CHMP recommends new Keytruda dosing schedule

    If approved by the European Commission, the Keytruda 400 mg every six weeks dose will provide both physicians and patients with greater flexibility in their treatment plans.”.

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Latest Intelligence

  • The Orkambi row explained The Orkambi row explained

    European Commission approves a label extension for Orkambi for two-to-five year-old children with CF who have two copies of the F508del mutation, the most common form of the

  • Innovation in merger control and the impact on the pharmaceutical sector Innovation in merger control and the impact on the pharmaceutical sector

    Is focusing on pipeline products enough to assess regulatory risks? The European Commission is increasingly concerned with how market consolidation could harm innovation. ... How the European Commission looks at the effect of horizontal mergers on

  • Changes to look out for in Medical Devices Regulations Changes to look out for in Medical Devices Regulations

    do their job. The European Commission has stated on its website that ‘the incident concerning fraudulent production of the PIP silicone breast implants highlighted weaknesses in the legal system in place ... Unlike PIP, DePuy is not expressly mentioned

  • Tools for the digital world Tools for the digital world

    Ada2020, funded by the European Commission, provides ‘a unique visual reasoning support for medical professionals during the diagnosis process’, with the aim of reducing the costs and patient suffering associated with

  • Building a bright future Building a bright future

    its report for the European Commission in May this year comments. ... The European Commission and European Medicines Agency should have a role in encouraging faster work from governments.”.

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Latest appointments

  • CureVac’s CEO appointed to EC High Level Group CureVac’s CEO appointed to EC High Level Group

    Dr Ingmar Hoerr, chief executive officer of clinical-stage mRNA technology specialist CureVac, has been appointed to the European Commission's High Level Group for research and innovation programmes. ... Dr Hoerr said: “It is a tremendous honor to be

  • New EC health director general takes office New EC health director general takes office

    XavierPrats Monné will report to health commissioner Dr Vytenis Andriukaitis. The European Commission's health and food safety directorate has a new director general, with Xavier Prats Monné taking over from ... A Spanish national, he has also served

  • European Commissioner for health and food safety elected European Commissioner for health and food safety elected

    Juncker said: “In the new European Commission, form follows function. We have to be open to change. ... We have to show that the Commission can change. What I present to you today is a political, dynamic and effective European Commission, geared to

  • MHRA appoints director of licensing MHRA appoints director of licensing

    Over his career he was worked with European and international partners on a number of European directives for pharmaceuticals and he has been the UK delegate to a number of European ... Commission Working Parties.

  • IDF appoints new CEO IDF appoints new CEO

    She gained experience in this role working with the World Heath Organization, the European Commission and governments on the use of communications technologies in healthcare systems. ... Her other healthcare roles include serving as director of the

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