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RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 04 Feb 2021
EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)
3 February 2021 - EMA’s CHMP has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax. ...
Posted by Michael Wonder on 01 Feb 2021
EU nations have received 18.5 million COVID-19 vaccines
2 February 2021 - Seeking to rebound from heavy criticism of its slow coronavirus vaccine rollout, the European Union said ...
Posted by Michael Wonder on 29 Jan 2021
Highlights from 25-29 January 2021 CHMP meeting
29 January 2021 - EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its January 2021 meeting. ...
Posted by Michael Wonder on 29 Jan 2021
EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
29 January 2021 - COVID-19 Vaccine AstraZeneca is now authorised across the EU. This follows the granting of a conditional marketing ...
Posted by Michael Wonder on 29 Jan 2021
First COVID-19 vaccine safety update published
29 January 2021 - Today EMA has released its first safety update on a COVID-19 vaccine — Comirnaty. ...
Posted by Michael Wonder on 28 Jan 2021
Germany moves to exclude seniors from AstraZeneca’s COVID-19 vaccine
28 January 2021 - Ahead of its expected approval for use by Europe’s medicines regulator Friday, Germany’s vaccine committee has recommended ...
Posted by Michael Wonder on 28 Jan 2021
Clarification of Comirnaty dosage interval
28 January 2021 - EMA’s human medicines committee (CHMP) has updated the product information for the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 27 Jan 2021
E.U. and U.K. fighting over scarce vaccines
27 January 2021 - As vaccine production falls behind schedule, and the European Union lags in inoculating people, Brussels and London ...
Posted by Michael Wonder on 27 Jan 2021
EU demands UK made AstraZeneca vaccine doses
27 January 2021 - The EU has urged pharmaceutical firm AstraZeneca to supply it with more doses of its COVID-19 ...
Posted by Michael Wonder on 25 Jan 2021
AstraZeneca is finding it hard to keep its COVID-19 vaccine promises
26 January 2021 - As countries scramble to inoculate their populations against COVID-19, the vaccine developed by AstraZeneca and the ...
Posted by Michael Wonder on 21 Jan 2021
Italy ponders suing Pfizer for delays in coronavirus vaccine
21 January 2021 - Italy's coronavirus commissioner is pressing ahead with plans to take legal action against Pfizer after the ...
Posted by Michael Wonder on 19 Jan 2021
Global regulators highlight key role of health care professionals in fostering confidence in COVID-19 vaccines
19 January 2021 - EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities ...