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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.

Bayer’s Vitrakvi scores first EU tumour-agnostic drug approval

The European Commission has given Vitrakvi conditional marketing authorisation in the EU for the treatment of adult and paediatric patients with solid tumours that display a NTRK gene fusion, which occurs ... The EU approval is good news for Bayer, as it

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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
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
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
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.
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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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
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
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
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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