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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.
Roche’s spinal muscular atrophy therapy Evrysdi approved by EC for newborns
The EC’s decision to extend the EU marketing authorisation for the therapy follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by an
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Novavax’s updated COVID-19 vaccine candidate shows promise against emerging subvariants
Last month, Novavax’s COVID-19 vaccine, Nuvaxovid, was granted full marketing authorisation in the EU for use as a primary series in individuals aged 12 years and older, and as ... The protein-based vaccine, which was originally granted a conditional
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Roche’s spinal muscular atrophy therapy recommended by CHMP for newborns
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the existing EU marketing authorisation for Evrysdi (risdiplam), which is approved to treat patients aged two months or older, ... The CHMP’s recommendation will now be
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Merck granted positive CHMP opinion for Keytruda combination in gastric cancer
or GEJ cancer, whose tumours express PD-L1 with a combined positive score one or more, in the EU.”. ... The CHMP’s recommendation will now be reviewed by the European Commission (EC) for marketing authorisation in the EU, with a final decision from
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Novavax’s COVID-19 vaccine granted full marketing authorisation in EU
Novavax has announced that its COVID-19 vaccine, Nuvaxovid, has been granted full marketing authorisation in the EU. ... Novavax’s protein-based vaccine, which was originally granted a conditional marketing authorisation in the EU for these indications,
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Gilead’s chronic hepatitis D antiviral shows long-term efficacy in late-stage trial
The treatment was initially granted conditional marketing authorisation in the EU in 2020 and has recently been recommended by the European Medicines Agency’s human medicines committee for full marketing authorisation ... The 96-week data not only
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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
Lundbeck filed a marketing authorisation application for Selincro in the EU with European Medicines Agency and a decision is expected later this year.
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Best practice in regulatory outsourcing: top tips
Activities requiring an EU presence include:. Holding a national or an EU Marketing Authorisation. ... Regulatory as a function has, in the past, been seen as the 'police' that says “no” to commercial and marketing plans.
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- Impacting Lives with Rare Disease Education
- Sandoz biosimilar receives EC approval to treat MS
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