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RSS FeedPosted by Michael Wonder on 18 Oct 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
18 October 2021 - EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to ...
Posted by Michael Wonder on 14 Oct 2021
EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
14 October 2021 - EMA’s CHMP has started a rolling review of Evusheld (also known as AZD7442), a combination of ...
Posted by Michael Wonder on 13 Oct 2021
EU may consider deal on Merck's COVID pill after approval procedure begins
12 October 2021 - The European Union may consider signing a supply deal with U.S. drugmaker Merck for its experimental ...
Posted by Michael Wonder on 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
Posted by Michael Wonder on 11 Oct 2021
EMA receives application for marketing authorisation for Ronapreve (casirivimab with imdevimab) for treatment and prevention of COVID-19
11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...
Posted by Michael Wonder on 06 Oct 2021
Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...
Posted by Michael Wonder on 06 Oct 2021
EMA to consider rolling review for Merck's molnupiravir in coming days
5 October 2021 - The EMA will consider in the coming days whether to launch a rolling review of Merck's ...
Posted by Michael Wonder on 05 Oct 2021
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
4 October 2021 - EMA’s CHMP has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax ...
Posted by Michael Wonder on 05 Oct 2021
EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19
4 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known ...
Posted by Michael Wonder on 27 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
27 September 2021 - EMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s ...
Posted by Michael Wonder on 24 Sep 2021
EU drugs regulator to decide on Pfizer vaccine booster in early October
23 September 2021 - The EMA aims to decide in early October whether to endorse a third dose of the ...
Posted by Michael Wonder on 21 Sep 2021
Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19
21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...
Posted by Michael Wonder on 06 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...
Posted by Michael Wonder on 05 Sep 2021
Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster
3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...
Posted by Michael Wonder on 24 Aug 2021
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech/Pfizer and Moderna
24 August 2021 - EMA’s CHMP has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the ...