Blog
RSS FeedPosted by Michael Wonder on 04 Jul 2023
Moderna submits regulatory application to the EMA for its updated COVID-19 vaccine
3 July 2023 - The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 ...
Posted by Michael Wonder on 30 Jun 2023
Moderna initiates rolling submission to Health Canada for updated COVID-19 vaccine
29 June 2023 - Health Canada submission follows international recommendations to develop monovalent XBB.1.5 COVID-19 vaccines. ...
Posted by Michael Wonder on 24 Jun 2023
Pfizer and BioNTech submit applications to US FDA for Omicron XBB.1.5 adapted monovalent COVID-19 vaccine
23 June 2023 - The submissions reflect guidance from FDA and other major health authorities to provide COVID-19 vaccines better matched ...
Posted by Michael Wonder on 23 Jun 2023
Moderna files for FDA authorisation of its updated COVID-19 vaccine
22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...
Posted by Michael Wonder on 14 Jun 2023
Tixagevimab and cilgavimab for the prevention of COVID-19 disease
14 June 2023 - NICE has published final evidence-based recommendations on the use of tixagevimab and cilgavimab (Evusheld) for the ...
Posted by Michael Wonder on 06 Jun 2023
EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants
6 June 2023 - The European Centre for Disease Prevention and Control and the European Medicines Agency have issued a ...
Posted by Michael Wonder on 01 Jun 2023
SK bioscience receives marketing authorisation of COVID-19 Vaccine from UK MHRA
30 May 2023 - SKYCovion is the world's first-ever vaccine developed utilising the RoseTTAFold, a software tool that uses deep learning. ...
Posted by Michael Wonder on 30 May 2023
Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants
30 May 2023 - International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and ...
Posted by Michael Wonder on 30 May 2023
ATAGI advice on the preferential use of bivalent COVID-19 vaccines for primary vaccination of people aged 12 years or older
30 May 2023 - ATAGI has made recommendations on the use of bivalent COVID-19 vaccines as a primary course. ...
Posted by Michael Wonder on 30 May 2023
Novavax's Nuvaxovid receives positive CHMP opinion for full marketing authorisation for the prevention of COVID in the EU
26 May 2023 - Novavax today announced that Nuvaxovid (NVX-CoV2373) has been recommended for full marketing authorisation for use as ...
Posted by Michael Wonder on 11 May 2023
EMA and European medicines regulatory network lift COVID-19 business continuity status
10 May 2023 - EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully ...
Posted by Michael Wonder on 09 May 2023
Nirmatrelvir and ritonavir for treating COVID-19
4 May 2023 - NICE is conducting a partial rapid review of TA878. ...
Posted by Michael Wonder on 09 May 2023
Statement from Emer Cooke on the end of the COVID-19 public health emergency
9 May 2023 - On Friday, the WHO Director General declared an end to the Public Health Emergency of International Concern ...
Posted by Michael Wonder on 27 Apr 2023
Moderna’s COVID-19 vaccine Spikevax receives approval for full registration
24 April 2023 - On 21 April, the TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, Spikevax (elasomeran), ...
Posted by Michael Wonder on 26 Apr 2023
Atea Pharmaceuticals announces US FDA fast track designation granted to bemnifosbuvir, an investigational oral anti-viral, for the treatment of COVID-19
25 April 2023 - Atea Pharmaceuticals today announced that the United States FDA has granted fast track designation to bemnifosbuvir for ...