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RSS FeedPosted by Michael Wonder on 05 Oct 2020
EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
5 October 2020 - The EMA has re-affirmed today that it will uphold its long-standing commitment to independence and transparency ...
Posted by Michael Wonder on 01 Oct 2020
EMA starts first rolling review of a COVID-19 vaccine in the EU
1 October 2020 - EMA’s CHMP has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed ...
Posted by Michael Wonder on 20 Sep 2020
Sanofi and GSK will provide up to 300 million doses of COVID-19 vaccine to the European Union
18 September 2020 - Agreement signed today supports scale-up of manufacturing capabilities in several European countries. ...
Posted by Michael Wonder on 18 Sep 2020
EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
18 September 2020 - EMA’s CHMP has completed its review of results from the RECOVERY study arm that involved the ...
Posted by Michael Wonder on 02 Sep 2020
EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19
2 September 2020 - EMA has started evaluating an application for the authorisation of Dexamethasone Taw for treating hospitalised adult patients ...
Posted by Michael Wonder on 17 Aug 2020
AstraZeneca seals deal with EC for coronavirus vaccine supply
17 August 2020 - AstraZeneca has finalised an agreement with the European Commission to supply up to 400 million doses ...
Posted by Michael Wonder on 13 Aug 2020
Once we have it, will we use it? A European survey on willingness to be vaccinated against COVID-19
13 August 2020 - While the focus of attention currently is on developing a vaccine against the Coronavirus SARS-CoV-2 to protect ...
Posted by Michael Wonder on 31 Jul 2020
Sanofi and GSK in advanced discussions with European Union to supply up to 300 million doses of COVID-19 vaccine
31 July 2020 - Both companies are committed to making their COVID-19 vaccine affordable and available globally. ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 real-world evidence and observational studies
31 July 2020 - Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main ...
Posted by Michael Wonder on 31 Jul 2020
Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials
31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...
Posted by Michael Wonder on 27 Jul 2020
EU talks with Pfizer, Sanofi, J&J on COVID vaccines hit snags
28 July 2020 - European efforts to secure potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson are mired in ...
Posted by Michael Wonder on 27 Jul 2020
EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support
24 July 2020 - EMA is reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the ...
Posted by Michael Wonder on 22 Jul 2020
First Covid-19 vaccine may be approved in 2020, EU regulator says
21 July 2020 - EMA will start rolling review of data, production after summer. ...
Posted by Michael Wonder on 21 Jul 2020
EMA sets up infrastructure for real-world monitoring of COVID-19 treatments and vaccines
21 July 2020 - EMA has now set up an infrastructure to support the monitoring of the efficacy and safety ...
Posted by Michael Wonder on 19 Jul 2020
Drug regulators remain united on COVID-19, says EU agency boss
18 July 2020 - The fight among governments to secure treatments has brought regulators closer together, says Guido Rasi. ...