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RSS FeedPosted by Michael Wonder on 25 Feb 2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
Posted by Michael Wonder on 24 Feb 2021
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
24 February 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known ...
Posted by Michael Wonder on 21 Feb 2021
von der Leyen admits to COVID-19 vaccine failures
20 February 2021 - EU Commission President Ursula von der Leyen's comments come after much scrutiny of the EU vaccination ...
Posted by Michael Wonder on 20 Feb 2021
Confusion over Russia's EU vaccine approval bid could be result of misdirected application
20 February 2021 - Russia’s submission of its Sputnik V vaccine for approval by the European Union’s medicines regulator appears ...
Posted by Michael Wonder on 18 Feb 2021
Pfizer and BioNTech to supply the European Union with 200 million additional doses of Cominarty
17 February 2021 - New agreement brings total supply to the European Union to 500 million doses, with delivery expected by ...
Posted by Michael Wonder on 16 Feb 2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
16 February 2021 - EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by Janssen-Cilag. ...
Posted by Michael Wonder on 12 Feb 2021
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
12 February 2021 - EMA’s human medicines committee (CHMP) has started a rolling review of CVnCoV, a COVID‑19 vaccine being ...
Posted by Michael Wonder on 10 Feb 2021
European Union admits errors in coronavirus vaccine rollout, 'deeply regrets' decision on export curbs
10 February 2021 - European Commission President Ursula von der Leyen has acknowledged failings in the EU's approval and rollout ...
Posted by Michael Wonder on 10 Feb 2021
EMA expected to approve Johnson & Johnson vaccine by March
10 February 2021 - The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by ...
Posted by Michael Wonder on 10 Feb 2021
Clarification on Sputnik V vaccine in the EU approval process
10 February 2021 - The EMA has to date not received an application for a rolling review or a marketing ...
Posted by Michael Wonder on 10 Feb 2021
EMA preparing guidance to tackle COVID-19 variants
10 February 2021 - EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new ...
Posted by Michael Wonder on 08 Feb 2021
International regulators working together to enhance collaboration on COVID-19 observational research
8 February 2021 - In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities, ...
Posted by Michael Wonder on 07 Feb 2021
Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorisation
4 February 2021 - Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada. ...
Posted by Michael Wonder on 04 Feb 2021
EMA reviewing data on monoclonal antibody use for COVID-19
4 February 2021 - EMA’s CHMP is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and ...
Posted by Michael Wonder on 04 Feb 2021
EMA COVID-19 assessments ‘OPEN’ to non-EU regulators
4 February 2021 - EMA is piloting a new ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines ...