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EC
This page shows the latest EC news and features for those working in and with pharma, biotech and healthcare.
Roche wins European approval for bleeding disorder treatment Hemlibra
The European Commission (EC) has approved Roche’s highly anticipated haemophilia treatment Hemlibra (emicizumab).
Latest news
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Roche faces biosimilar blitz in 2018
bevacizumab copycat approved by the EC.
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EC grants MSD’s Prevymis orphan product designation
EC grants MSD’ s Prevymis orphan product designation. The product will gain some market exclusivity benefits in CMV infection. ... The EC’s decision came on the back of phase III data showing that after 24 weeks following a transplant, only 37.5% of
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BMS' Yervoy picks up another indication in Europe
BMS' Yervoy picks up another indication in Europe. The EC licenses the immuno-oncology treatment for children with skin cancer.
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Amgen and Allergan win first EU approval for Avastin biosimilar
Sean Harper, executive vice president of research and development at Amgen, said: “The EC’s approval of Mvasi marks a significant milestone for both Amgen and the oncology community, providing a
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UK pharma welcomes Brexit breakthrough
UK pharma has welcomed last night’s breakthrough in the Brexit talks between the UK and the European Commission (EC) that saw agreement reached on the Irish border, EU citizens’rights ... The EC-UK agreement comes as the European life sciences sector
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Latest Intelligence
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The sound of silence puts the squeeze on generics and biosimilars
EFPIA issued a statement on its position, stating: “The SPC regime is part of the current EC review of incentives.
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European CTR implementation advances ethical assessment of clinical trials
well as a clear process of selection of a Central ‘EC’that will be dealing with a trial. ... who would deal with a selection of the appropriate EC, timelines and financial aspects.
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Europe vs the US: New drug product approvals
pending approval by the European Commission (EC) in January 2017 (compared to no biosimilars gaining EU approval in 2015).
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Real-world evidence: It’s all in the approach
the EC point out the uses of such data in supporting pharmacovigilance, comparative efficacy and pricing negotiations for new treatments.
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Brexit: Implications for the pharma industry
20/EC), (ii) the Medical Devices Directive (EU Directive 93/42/EC), (iii) the Active Implantable Medical Devices Directive (EU Directive 90/385/EC) and (iv) the In Vitro Medical Devices ... Marketing Authorisations, pricing and reimbursement. Most
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Latest appointments
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CureVac’s CEO appointed to EC High Level Group
CureVac’ s CEO appointed to EC High Level Group. Dr Ingmar Hoerr will advise on Horizon 2020 and future innovation programmes. ... Dr Hoerr joins a panel of 15 group members who will advise the EC on how to strengthen support for breakthrough,
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New EC health director general takes office
New EC health director general takes office. XavierPrats Monné will report to health commissioner Dr Vytenis Andriukaitis. ... Prats Monné's appointment was part of a reshuffle of the Commission's senior management by president Jean-Claude Juncker and,
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IMI appoints new chair of scientific committee
IMI appoints new chair of scientific committee. Portugal’ s Maria Beatriz da Silva Lima to join EC’ s collaborative research group. ... the EC and the industry to improve health innovation in Europe.
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Jonathan Dickinson joins Ariad from BMS
He joins at an important time for Ariad in Europe as it prepares to launch its chronic myeloid leukaemia treatment Iclusig (ponatinib), pending approval from the European Commission (EC).
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Tonio Borg nominated to replace John Dalli as EC Health Commissioner
Tonio Borg nominated to replace John Dalli as EC Health Commissioner.
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Latest from PMHub
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Ensuring quality in medical translation when working ‘blind’
There is also often the need for a review by an Ethics Committee (EC), which can remove some errors, but can introduce spelling or grammar errors too. ... Any EC or client changes should be sent back to the original translators to be checked again.
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Can rare diseases be a viable option for the pharma industry?
EU has enacted similar legislation, Regulation (EC) No 141/2000, in which pharmaceuticals developed to treat rare diseases are referred to as “ orphan medicinal products”.
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What we learnt from taking a mobile app through MHRA compliance
Mobile app medical compliance. We launched an app that conforms to the EU Medical Device Directive 2007/47 EC for Rosemont Pharmaceuticals who are now registered as a Class 1 device
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EC Meetings Company Ltd.
EC Meetings Company Ltd. ECMeetings Malta gives you the opportunity of looking at Malta with a fresh set of eyes, gaining a new perspective on how things could, should and would ... EC Meetings Company Ltd..
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