Merck receives EU CHMP positive opinion for investigational V920 Ebola Zaire vaccine for protection against Ebola virus disease

18 October 2019 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending a conditional ...

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First Algenex CrisBio-based vaccine submitted to European Medicines Agency

15 October 2019 - Potential approval would validate the use of Algenex’ CrisBio technology for the manufacture of recombinant subunit vaccines. ...

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Emergent BioSolutions receives EMA Prime Designation for its Chikungunya virus vaccine candidate

10 October 2019 - Emergent BioSolutions today announced that the company’s chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, ...

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Emergent BioSolutions announces granting of marketing authorisation in Five EU countries for its oral typhoid vaccine; expands availability across Europe

20 May 2019 - Emergent BioSolutions announced today that it has successfully obtained marketing authorization for its oral typhoid vaccine Vivotif ...

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Dynavax announces European Medicines Agency accepts marketing authorisation application for Heplisav-B for prevention of hepatitis B in adults

28 March 2019 - Dynavax Technologies today announced that the EMA has accepted the Company’s marketing authorisation application for review ...

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Sanofi UK marketing authorisation granted for Sanofi Pasteur’s trivalent influenza vaccine (split virion, inactivated) high dose (TIV high dose)

21 January 2019 - UK is the only European country where TIV high dose is approved. ...

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Approval for Seqirus flu vaccine

15 January 2019 - Seqirus has announced European approval of its new cell-based quadrivalent influenza vaccine. ...

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Dengvaxia vaccine approved for prevention of dengue in Europe

19 December 2018 - The European Commission has granted marketing authorization for Dengvaxia®, Sanofi’s dengue vaccine.  ...

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Fast-track flu vaccine raises hopes for quicker drugs approvals

24 October 2018 - Post-Brexit registrations could be ‘five months faster’, says medicines regulator. ...

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EMA takes issue with BMJ article on Pandemrix vaccine

27 September 2018 - A recent article in the BMJ suggested that one pandemic flu vaccine was less safe than ...

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Themis receives EMA PRIME designation for Chikungunya vaccine

11 June 2018 -Themis announced today that the EMA has granted PRIority MEdicines (PRIME) designation to its most advanced program ...

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Update of EU recommendations for 2018/2019 seasonal flu vaccine composition

30 April 2018 - Update to recommendations issued in March 2018. ...

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Updated rules for clinical development of vaccines

26 April 2018 - EMA launches public consultation on revised guideline on clinical evaluation of vaccines. ...

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EU recommendations for 2018/2019 seasonal flu vaccine composition

26 March 2018 - EU advice based on WHO recommendations. ...

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Shingrix approved in Europe and Japan for the prevention of shingles in adults aged 50 and over

23 March 2018 - The only shingles vaccine to achieve ≥90% efficacy across all age groups studied. ...

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