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EU marketing authorisation
This page shows the latest EU marketing authorisation news and features for those working in and with pharma, biotech and healthcare.
Time running out for ‘no-deal’ Brexit medicines laws
It says it will allow the parallel import of medicinal products that hold a marketing authorisation from an EU or EEA country, along with continuing to recognise prescriptions issued in EU ... UK to continue functioning should it have to leave the EU
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Daily Brief: Andrew Witty's replacement on Accelerated Access initiative, Blincyto gains full EU approval and more
Blincyto gains full approval in Europe. Amgen’s leukemia treatment Blincyto, has been given full marketing authorisation in Europe, two years on from its first launch. ... The novel immunotherapy was first granted conditional marketing authorisation in
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MSD launches EU’s first biosimilar Herceptin in UK
Ontruzant isn’t the only Herceptin biosimilar approved for marketing in Europe. ... Ontruzant was the fourth biosimilar developed by the Korean company to receive marketing authorisation in the EU, after Benepali (etanercept), Flixabi (infliximab), and
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First Herceptin biosimilar cleared in Europe
Roche is claiming patent protection for Herceptin in the US out to 2019, but its EU patents expired in 2014. ... Ontruzant is the fourth biosimilar developed by the Korean company to receive marketing authorisation in the EU.
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NICE backs Sanofi's Kevzara for routine NHS use
The product - which was developed jointly by Sanofi and Regeneron - was granted EU marketing authorisation for the same indication back in June 2017, but now can be made available for use
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Chiesi Group's Trimbow wins European licence
Alessandro Chiesi, region Europe Head of Chiesi Group, said: “The marketing authorisation of Trimbow in the EU is a significant treatment advance for COPD patients and reinforces the Chiesi Group’s ... Although the first medicine of its type approved
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Brexit implications for UK pharma legislation
require a significant increase in resourcing, met (mostly) by fees for assessing marketing authorisation applications and other services. ... Companies must be established in the EU to hold an EU/EEA marketing authorisation, and exports from the UK would
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Shoring up the framework
Marketing authorisation holders for medicines, including orphan drugs, must be established in the EU or EEA. ... So for centrally authorised products the marketing authorisation holder will therefore normally need to transfer its marketing authorisation
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Pharma deals during September 2012
Biotie will receive additional sales milestones on achievement of undisclosed sales target in Japan, increasing total reward to 89m ($120m). Lundbeck filed a marketing authorisation application for Selincro in the EU
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Best practice in regulatory outsourcing: top tips
Holding a national or an EU Marketing Authorisation. Distribution that requires a licence (a Wholesale Dealers Licence and the services of a Responsible Person in the UK). ... Regulatory as a function has, in the past, been seen as the 'police' that says
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