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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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