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European Commission approves contract with BioNTech-Pfizer alliance
worldpharmanews
November 12, 2020
Yesterday, the European Commission approved a fourth contract with pharmaceutical companies BioNTech and Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to request up to a further ...
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UK and EU agree on phased process for Northern Ireland medicines regulation
pharmatimes
November 10, 2020
The UK government and the European Commission (EC) have reached an agreed approach on a phased process for implementing medicines regulation in Northern Ireland following Brexit (31 December).
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Lynparza scores two new EU approvals
pharmatimes
November 09, 2020
AstraZeneca and MSD's immunotherapy Lynparza (olaparib) has scored two new approvals in the European Union.
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Vertex’s Kalydeco scores another label extension in EU
pharmatimes
November 09, 2020
Vertex has scored approval from the European Commission to extend the label for Kalydeco (ivacaftor) to include the treatment o infants with cystic fibrosis (CF) aged four months or older.
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EU signs contract with J&J on Covid-19 vaccine candidate
pharmaceutical-technology
October 23, 2020
The European Commission (EC) has signed a contract on behalf of European Union (EU) states with Johnson & Johnson (J&J) for the supply of 400 million doses of its Covid-19 vaccine candidate.
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CHMP recommends AstraZeneca’s Forxiga for approval in EU
pharmaceutical-technology
October 21, 2020
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended AstraZeneca’s Forxiga (dapagliflozin) for an indication extension of its marketing authorisation in the European Union (EU).
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ABPI chief exec says no-deal Brexit is ‘not in the interest of patients’
pharmatimes
October 21, 2020
Following prime minister Boris Johnson’s announcement last week that he was preparing for a no-deal with the EU, the Association for the British Pharmaceutical Industry (ABPI) has warned against such an outcome.
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Ten new medicines backed for EU approval
pharmatimes
October 21, 2020
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended ten new medicines for approval at its October 2020 meeting.
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COVID-19 to influence the outcome of Brexit: Poll
pharmaceutical-technology
October 15, 2020
The Brexit transition deadline of 31 December 2020 is fast approaching, but a trade deal between the UK and European Union (EU) is yet to be finalised.
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EU to receive 300 million COVID-19 vaccine doses from Sanofi and GSK
europeanpharmaceuticalreview
September 27, 2020
A contract for 300 doses of the investigational COVID-19 vaccine candidate has been signed by the European Commission (EC).