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Imfinzi approved in the EU for less-frequent, fixed-dose use in unresectable non-small cell lung cancer pharmaceutical-business-review
January 20, 2021
New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience.
EU OK for Roche’s oral flu treatment Xofluza pharmatimes
January 12, 2021
The European Commission (EC) has approved Roche’s oral treatment Xofluza (baloxavir marboxil) for the treatment of influenza.
EU authorises intramuscular administration of Biogen’s Plegridy for MS pharmatimes
January 07, 2021
A new intramuscular (IM) injection option of Biogen’s Plegridy (peginterferon beta-1a) has been approved by the European Commission for the treatment of relapsing-remitting multiple sclerosis (MS).
AstraZeneca and Oxford-made Covid-19 vaccine not ready for EU market approval pharmaceutical-technology
December 30, 2020
The European Medicines Authority (EMA) has said that the drug maker AstraZeneca and the University of Oxford’s COVID-19 vaccine may not be approved in January next year.
Europe rolls out vaccines against COVID-19 expresspharma
December 28, 2020
The region has secured contracts with a range of suppliers for over two billion vaccine doses and has set a goal for all adults to be inoculated during 2021.
Pfizer, BioNTech win EU authorisation for COVID-19 vaccine Comirnaty pharmatimes
December 23, 2020
The European Commission (EC) has granted Pfizer/BioNTech’s COVID-19 vaccine a conditional marketing authorisation (CMA), under the new name Comirnaty.
EU nod for first long-acting HIV injectable treatment pharmatimes
December 22, 2020
The European Commission (EC) has authorised Janssen’s Rekambys (rilpivirine injection) in combination with ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to treat HIV-1 infections in adults who are virologically suppressed.
Novo Nordisk eyes EU approval for once-weekly semaglutide pharmatimes
December 21, 2020
Danish pharma company Novo Nordisk has submitted a marketing authorisation application the European Medicines Agency (EMA), seeking approval for once-weekly semaglutide for weight management.
EU for AZ' COPD maintenance therapy pharmatimes
December 15, 2020
AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been approved in the EU for maintenance treatment in adults with moderate to severe chronic obstructive pulmonary disease (COPD).
Novartis’ cholesterol med Leqvio wins EU approval pharmatimes
December 15, 2020
Swiss pharma company Novartis’ cholesterol-lowering drug Leqvio (inclisiran) has been granted approval from the European Commission (EC) for the treatment of primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidaemia.

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