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RSS FeedPosted by Michael Wonder on 18 Sep 2021
Pharmacist substitution of PBS medicines without a prescription during shortages (Serious Scarcity Substitution Instrument)
18 September 2021 - Where a Serious Scarcity Substitution Instrument has been issued by the TGA, community pharmacists can substitute specific ...
Posted by Michael Wonder on 18 Sep 2021
FDA advisory committee votes unanimously in favour of Comirnaty booster for emergency use in people 65 and older and certain high risk population
17 September 2021 - Committee reviewed clinical data showing a booster dose of Comirnaty elicits high neutralisation titres against SARS-CoV-2 and ...
Posted by Michael Wonder on 17 Sep 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full Health Canada approval for individuals 12 years and older
16 September 2021 - Health Canada Notice of Compliance is based on a comprehensive submission package including six month efficacy ...
Posted by Michael Wonder on 16 Sep 2021
Moderna announces Health Canada approves its COVID-19 vaccine
16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...
Posted by Michael Wonder on 16 Sep 2021
ATAGI update following weekly COVID-19 meeting – 15 September 2021
16 September 2021 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 15 ...
Posted by Michael Wonder on 16 Sep 2021
Emergency use authorisation for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
16 September 2021 - Expanded emergency use authorisation includes certain people who have been exposed to someone infected with SARS-CoV-2 ...
Posted by Michael Wonder on 16 Sep 2021
COVID-19 vaccine weekly safety report (16 September 2021)
16 September 2021 - To 12 September 2021, approximately 22.8 million vaccine doses have been given in Australia – 14 million ...
Posted by Michael Wonder on 16 Sep 2021
PHARMAC funds tocilizumab to treat cases of COVID-19
16 September 2021 - PHARMAC is widening funded access to tocilizumab, an immunosuppressive drug used mainly to treat arthritis, to treat ...
Posted by Michael Wonder on 15 Sep 2021
Lilly to supply 388,000 doses of etesevimab to U.S. Government for treatment of COVID-19
15 September 2021 - Additional doses of etesevimab will be paired with existing bamlanivimab purchased by the U.S. Government ...
Posted by Michael Wonder on 15 Sep 2021
Regeneron announces new U.S. Government agreement to purchase additional doses of REGEN-COV (casirivimab and imdemivab) antibody cocktail
14 September 2021 - New agreement for 1.4 million doses of REGEN-COV, brings total purchased by the U.S. government to nearly ...
Posted by Michael Wonder on 15 Sep 2021
Medicines Australia and AusBiotech say COVID-19 vaccine patent waiver will not speed up global vaccination
15 September 2021 - Medicines Australia and AusBiotech, the peak bodies representing the Australian innovative pharmaceutical and biotechnology sectors, urge ...
Posted by Michael Wonder on 14 Sep 2021
Access Consortium: alignment with ICMRA consensus on immunobridging for authorising new COVID-19 vaccines
14 September 2021 - Placebo controlled disease outcome trial data are the gold standard for authorising vaccines. However, for COVID-19 ...
Posted by Michael Wonder on 13 Sep 2021
UK terminates Valneva COVID-19 vaccine supply agreement
13 September 2021 - The UK government has terminated its supply agreement with French firm Valneva for its COVID-19 vaccine ...
Posted by Michael Wonder on 11 Sep 2021
MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines
9 September 2021 - The regulatory changes made by the MHRA today give further options for the deployment programme. ...
Posted by Michael Wonder on 09 Sep 2021
COVID-19 vaccine weekly safety report (9 September 2021)
9 September 2021 - To 5 September 2021, approximately 21 million vaccine doses have been given in Australia – 13.1 million ...