Blog
RSS FeedPosted by Michael Wonder on 07 Dec 2021
EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
7 December 2021 - ‘Mix-and-match’ approach can be used for both initial courses and boosters. ...
Posted by Michael Wonder on 06 Dec 2021
EMA recommends approval for use of RoActemra in adults with severe COVID-19
6 December 2021 - The EMA’s CHMP has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of ...
Posted by Michael Wonder on 03 Dec 2021
ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic
3 December 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation have reviewed some of ...
Posted by Michael Wonder on 02 Dec 2021
EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
2 December 2021 - The EMA’s CHMP has started a rolling review of VLA2001, a COVID-19 vaccine being developed by ...
Posted by Michael Wonder on 25 Nov 2021
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
25 November 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 23 Nov 2021
EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19
23 November 2021 - EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). ...
Posted by Michael Wonder on 22 Nov 2021
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen
22 November 2021 - EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine ...
Posted by Michael Wonder on 20 Nov 2021
EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19
19 November 2021 - EMA’s CHMP has issued advice on the use of Lagevrio (molnupiravir, MK 4482) for the treatment of ...
Posted by Michael Wonder on 20 Nov 2021
EMA starts review of Paxlovid for treating patients with COVID-19
19 November 2021 - EMA is reviewing currently available data on the use of Paxlovid (PF-07321332/ritonavir), an oral treatment for COVID-19 ...
Posted by Michael Wonder on 17 Nov 2021
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
17 November 2021 - EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known ...
Posted by Michael Wonder on 15 Nov 2021
Celltrion’s monoclonal antibody treatment regdanvimab, approved by the European Commission for the treatment of COVID-19
14 November 2021 - The European Commission granted marketing authorisation for Celltrion’s regdanvimab following positive opinion by the EMA's CHMP last ...
Posted by Michael Wonder on 11 Nov 2021
Valneva receives EU deal for COVID jab, and seeks apology from UK
11 November 2021 - French vaccine manufacturer, Valneva, has announced that it has won EU approval to supply up to 60 ...
Posted by Michael Wonder on 11 Nov 2021
COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
11 November 2021 - EMA’s CHMP has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. ...
Posted by Michael Wonder on 10 Nov 2021
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...
Posted by Michael Wonder on 09 Nov 2021
Moderna files to expand the conditional marketing authorisation for its COVID-19 vaccine in the European Union to include children ages 6-11 years
9 November 2021 - Submission based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11. ...