Vaccinations can end political blame game: CSL

13 October 2021 - CSL chief Paul Perreault has warned that the politicisation of Covid-19 is ­fuelling vaccination hesitancy as ...

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EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac

13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...

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Merck and Ridgeback announce submission of emergency use authorisation application to the U.S. FDA for molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild to moderate COVID-19 in at risk adults

11 October 2021 - Submissions to regulatory agencies worldwide underway. ...

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EMA receives application for marketing authorisation for Ronapreve (casirivimab with imdevimab) for treatment and prevention of COVID-19

11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...

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PHARMAC negotiates deal for molnupiravir to treat COVID-19

11 October 2021 - PHARMAC has negotiated an agreement with supplier MSD to purchase the antiviral molnupiravir.  ...

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Brii Bio initiates submission of emergency use authorisation filing to U.S. FDA for BRII-196/BRII-198, its monoclonal antibody combination therapy for non-hospitalised COVID-19 patients at high risk of clinical progression to severe disease

8 October 2021 - Data supporting the EUA filing will be submitted to the FDA on a rolling basis with the ...

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Booster shot for severely immunocompromised Australians

8 October 2021 - From next week Australians who are severely immunocompromised will be offered the option to receive a third ...

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Pfizer seeks US authorisation of Covid-19 vaccine for ages 5-11

8 October 2021 - The Pfizer vaccine could soon be available for children as young as five in the United States. ...

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Joint statement: supply allocations of intravenous tocilizumab (Actemra) during serious shortage

7 October 2021 - Roche, the sponsor of tocilizumab (Actemra), notified the TGA of shortages of multiple presentations of tocilizumab ...

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COVID-19 vaccine weekly safety report (7 October 2021)

7 October 2021 - To 3 October 2021, approximately 28.8 million vaccine doses have been given in Australia 17 million first ...

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Moderna asks Health Canada to approve COVID-19 vaccine booster shot

5 October 2021 - Moderna has applied for Canadian approval of a third dose of its COVID-19 vaccine, the company ...

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Where has PHARMAC gone?

7 October 2021 - As debate has intensified over the last year or so about the procurement of New Zealand’s ...

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Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older

5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...

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EMA to consider rolling review for Merck's molnupiravir in coming days

5 October 2021 - The EMA will consider in the coming days whether to launch a rolling review of Merck's ...

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Johnson & Johnson announces submission of emergency use authorisation amendment to the U.S. FDA to support booster of its single shot COVID-19 vaccine

5 October 2021 - Submission includes data showing a booster increased protection to 94% against moderate to severe/critical COVID-19 in the ...

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