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RSS FeedPosted by Michael Wonder on 31 Aug 2023
InflaRx’s marketing authorisation application for vilobelimab for treatment of critically ill COVID-19 patients under review by European Medicines Agency
30 August 2023 - Regulatory submission based on pivotal data from PANAMO Phase III trial. ...
Posted by Michael Wonder on 30 Aug 2023
EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
30 August 2023 - The EMA’s CHMP has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant. ...
Posted by Michael Wonder on 22 Aug 2023
CDC, pharmacies try to speed up Covid vaccine program for the uninsured
21 August 2023 - The timing gap prompted concerns from public health experts, who fear that it would further complicate the ...
Posted by Michael Wonder on 16 Aug 2023
PHARMAC calls for applications from the suppliers of vaccines that protect against COVID-19
16 August 2023 - PHARMAC is interested to hear from pharmaceutical suppliers who manufacture vaccines that protect against COVID-19 and ...
Posted by Michael Wonder on 10 Aug 2023
New COVID-19 vaccine and booster shots for this fall to be available by end of September
9 August 2023 - The first new COVID-19 vaccines updated for this fall season are now expected to be available by ...
Posted by Michael Wonder on 01 Aug 2023
PHARMAC considers access criteria for COVID-19 anti-viral treatments
1 August 2023 - PHARMAC is consulting on changes to the access criteria for all COVID-19 anti-viral treatments to include ...
Posted by Michael Wonder on 27 Jul 2023
Molnupiravir will remain available for people who need it
27 July 2023 - PHARMAC has confirmed today that molnupiravir will remain available as a treatment to protect against infection ...
Posted by Michael Wonder on 07 Jul 2023
Phasing out of extraordinary COVID-19 regulatory flexibilities
6 July 2023 - EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the ...
Posted by Michael Wonder on 06 Jul 2023
Moderna announces global regulatory submissions for its respiratory syncytial virus (RSV) vaccine, mRNA-1345
5 July 2023 - Moderna has submitted marketing authorization applications for the investigational RSV vaccine, mRNA-1345, with the European Medicines Agency, ...
Posted by Michael Wonder on 05 Jul 2023
Global regulators confirm good safety profile of COVID-19 vaccines
5 July 2023 - EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the ...
Posted 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 ...