Australia left in the dark as manufacturers race to make Oxford COVID-19 vaccine

22 July 2020 - Australia may have to compete with other nations to import supply of the University of Oxford's ...

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TGA publishes AusPAR for Vemlidy

21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...

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Australian COVID researchers warn vaccines will have to be made overseas

20 July 2020 - Researchers at Monash University say if their COVID-19 vaccine is successful they will be forced to ...

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Actual and potential harm caused by medical software

16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...

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Deciphera announces Australian Therapeutic Goods Administration’s approval of Qinlock (ripretinib) for the treatment of fourth-line gastro-intestinal stromal tumour

14 July 2020 - Qinlock is the first approved tyrosine kinase inhibitor designed specifically for GIST regardless of patients’ mutational status. ...

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Gilead rushes to meet remdesivir demand as virus pressures grow

15 July 2020 - Global pharmaceuticals giant Gilead has flagged the supply of its coronavirus treatment remdesivir will be constrained ...

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TGA publishes more details on its approval of COVID-19 medicine Veklury

13 July 2020 - Remdesivir granted conditional approval in record time. ...

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Australian vaccine trial starts today

13 July 2020 - Australian scientists are on track to deliver a COVID-19 vaccine this year, with the start on Monday ...

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Australia's first COVID treatment approved

10 July 2020 - The Therapeutic Goods Administration has granted provisional approval to remdesivir (Veklury, Gilead Sciences) as the first ...

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Cochlear calls for low risk health apps to be exempt from TGA register

3 July 2020 - Hearing implant giant Cochlear has called for some low risk health apps to be exempt from ...

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Gilead donates COVID-19 drug remdesivir to Australia’s medical stockpile after US buys up supply

2 July 2020 - The US pharmaceutical giant Gilead has donated a supply of the anti-viral medication remdesivir to Australia’s ...

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Reduced annual charges for medical devices listed on the prostheses list

2 July 2020 - In response to the suspension of elective surgery due to COVID-19 and the significant impact this has ...

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Medicines Australia welcomes support for national harmonisation of clinical trials

30 June 2020 - Medicines Australia welcomes the announcement from the Minister for Health, the Hon Greg Hunt MP, during ...

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US painkiller to be sold in Australian pharmacies to shore up supply

25 June 2020 - Global pharmaceutical giant Johnson & Johnson has been given approval to sell its US painkiller brand ...

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Submissions received: fees and charges proposal 2020-21

23 June 2020 - On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, ...

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