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RSS FeedPosted by Michael Wonder on 26 Jan 2023
Update on US FDA emergency use authorisation of Evusheld
26 January 2023 - The US FDA has stated that AstraZeneca’s Evusheld (tixagevimab and cilgavimab) is not currently authorised for ...
Posted by Michael Wonder on 23 Jan 2023
TGA grants provisional approval to Pfizer’s COVID-19 bivalent (Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccine
23 January 2023 - On 20 January 2023, the TGA granted provisional approval to Pfizer’s bivalent COVID-19 vaccine: tozinameran and famtozinameran ...
Posted by Michael Wonder on 13 Jan 2023
COVID-19 vaccine safety report (12 January 2023)
12 January 2023 - Since the beginning of the vaccine rollout to 8 January 2023, almost 65 million doses of COVID-19 ...
Posted by Michael Wonder on 13 Jan 2023
Daiichi Sankyo submits application for marketing approval of mRNA COVID-19 vaccine (DS-5670) in Japan
13 January 2023 - Daiichi Sankyo today announced the submission of an application for marketing approval of DS-5670 to the ...
Posted by Michael Wonder on 13 Jan 2023
COVID treatment molnupiravir to hit Chinese market on Friday
12 January 2023 - The COVID-19 treatment molnupiravir is expected to hit the Chinese market on Friday, after passing its ...
Posted by Michael Wonder on 12 Jan 2023
Pfizer's Paxlovid not included in China's national insurance
9 January 2023 - China will not include Pfizer’s COVID-19 treatment drug in a national reimbursement list that would have allowed ...
Posted by Michael Wonder on 10 Jan 2023
Moderna considers price of $110-$130 for COVID-19 vaccine
9 January 2023 - Commercial price is similar to Pfizer’s plans for after government contracting ends. ...
Posted by Michael Wonder on 22 Dec 2022
COVID-19 vaccine safety report (22 December 2022)
22 December 2022 - This is an abbreviated version of the COVID-19 vaccine safety report. ...
Posted by Michael Wonder on 21 Dec 2022
FDA approves Genentech’s Actemra for the treatment of COVID-19 in hospitalised adults
21 December 2022 - Actemra is the first FDA approved monoclonal antibody to treat COVID-19. ...
Posted by Michael Wonder on 21 Dec 2022
Sanofi Pasteur COVID-19 vaccine authorised by MHRA
21 December 2022 - VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, has been authorised by the MHRA. ...
Posted by Michael Wonder on 20 Dec 2022
ICER provides update on value based pricing of Paxlovid as an outpatient treatment for COVID-19
20 December 2022 - New data suggests Paxlovid will achieve common thresholds of cost effectiveness if priced between $563-$906 per treatment ...
Posted by Michael Wonder on 20 Dec 2022
COVID-19 vaccine safety report (15 December 2022)
15 December 2022 - To 11 December 2022, the TGA has received 706 reports which have been assessed as likely to ...
Posted by Michael Wonder on 19 Dec 2022
New report indicates COVID-19 vaccines saved Australia’s economy
19 December 2022 - Medicines Australia welcomes the latest peer-reviewed research paper indicating the rollout of the COVID-19 vaccinations significantly ...
Posted by Michael Wonder on 10 Dec 2022
Health Canada authorises the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent adapted COVID-19 booster for children 5 to 11 years of age
9 December 2022 - Today, Health Canada authorised the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent adapted booster for use in children 5 ...
Posted by Michael Wonder on 10 Dec 2022
Pfizer and BioNTech receive US FDA fast track designation for single dose mRNA based vaccine candidate against COVID-19 and influenza
9 December 2022 - Pfizer and BioNTech today announced the companies have received fast track designation from the US FDA ...