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RSS FeedPosted by Michael Wonder on 19 Nov 2020
EMA organises public meeting on COVID-19 vaccines
19 November 2020 - EMA will organise a public meeting on 11 December 2020 to inform European citizens about the ...
Posted by Michael Wonder on 16 Nov 2020
EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain
16 November 2020 - EMA’s CHMP has started a ‘rolling review’ of data on a vaccine for COVID-19 known as ...
Posted by Michael Wonder on 13 Nov 2020
EU secures 300 million doses of BioNTech, Pfizer’s COVID-19 vaccine
13 November 2020 - The European Commission has secured a supply deal with BioNTech and Pfizer for 300 million doses ...
Posted by Michael Wonder on 06 Nov 2020
International regulators and WHO join forces to address COVID-19 challenges
6 November 2020 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have committed to working together ...
Posted by Michael Wonder on 05 Nov 2020
EMA will assess potential COVID-19 vaccine on ‘case by case’ basis
5 November 2020 - Agency will not specify a minimum level of efficacy. ...
Posted by Michael Wonder on 31 Oct 2020
Extra transparency measures for COVID-19 vaccines and therapeutics
30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...
Posted by Michael Wonder on 28 Oct 2020
Sanofi and GSK to support COVAX with 200 million doses of adjuvanted, recombinant protein based COVID-19 vaccine
28 October 2020 - COVAX Facility is led by Gavi and aims to secure successful and equitable access to COVID-19 vaccines ...
Posted by Michael Wonder on 26 Oct 2020
European Union would apply lower threshold in assessing COVID-19 vaccine
25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...
Posted by Michael Wonder on 15 Oct 2020
EMA confirms eligibility for submission of Moderna’s COVID-19 vaccine
15 October 2020 - The EMA has confirmed that Moderna’s COVID-19 vaccine candidate mRNA-1273 is eligible for submission under the ...
Posted by Michael Wonder on 09 Oct 2020
Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen’s COVID-19 vaccine candidate
8 October 2020 - Agreement provides option for European Union Member States to secure up to 200 million additional doses for ...
Posted by Michael Wonder on 08 Oct 2020
Gilead inks supply agreement with the European Commission for remdesivir
8 October 2020 - Gilead has signed a joint procurement agreement with the European Commission to enable ‘rapid and equitable’ ...
Posted by Michael Wonder on 07 Oct 2020
European countries face shortages of COVID-19 drug remdesivir
7 October 2020 - European countries are facing shortages of COVID-19 drug remdesivir because limited supplies are running out, officials said, ...
Posted by Michael Wonder on 06 Oct 2020
EMA starts second rolling review of a COVID-19 vaccine
6 October 2020 - EMA’s CHMP has started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, ...
Posted by Michael Wonder on 05 Oct 2020
EU regulator starts safety review of coronavirus drug
3 October 2020 - The European Medicines Agency says it has started a safety review after some patients taking the ...