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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.
Pfizer/BioNTech’s COVID-19 vaccine is 100% effective in adolescents
emergency use authorisation for the vaccine in the US and the conditional marketing authorisation currently in place in the EU.
Latest news
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J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval
J&J's pharma division Janssen announced today that the CHMP recommends approval of the marketing authorisation for Ponvory (ponesimod), for the treatment of adult patients with relapsing MS (RMS), with ... The EU marketing authorisation application for
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UPDATED: Regeneron’s COVID-19 antibody cocktail shows ‘clear efficacy’
When this review is finalised, it will be used as the basis for an EU marketing authorisation for the treatment. ... Last November, the US Food and Drug Administration (FDA) granted REGEN-COV an emergency use authorisation (EUA) for the treatment of mild
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EU announces agreement with Gilead for remdesivir supply
Drug was granted conditional marketing authorisation in the EU in July. ... The JPA replaces the initial deal funded by the EU’s emergency support instrument that ran from August through to October 2020.
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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
J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval
UPDATED: Regeneron’s COVID-19 antibody cocktail shows ‘clear efficacy’
EU announces agreement with Gilead for remdesivir supply
Bayer’s Vitrakvi scores first EU tumour-agnostic drug approval
Time running out for ‘no-deal’ Brexit medicines laws
More from news
Approximately 1 fully matching, plus 59 partially matching documents found.
Latest Intelligence
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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
Brexit implications for UK pharma legislation
Shoring up the framework
Pharma deals during September 2012
Best practice in regulatory outsourcing: top tips
More from intelligence
Approximately 0 fully matching, plus 4 partially matching documents found.
COVID-19 Updates and Daily News
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