Alimera announces Iluvien regulatory approval in Australia for the treatment of diabetic macular oedema

5 August 2019 - Specialised Therapeutics, an Australian biopharmaceutical company and Alimera’s distribution partner, to next seek national reimbursement. ...

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Fast track pathways for drug approvals: the Australian experience so far

1 August 2019 - In 2016, the Australian Government announced that the Therapeutic Goods Administration would establish two new pathways ...

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Intellectual property law amends will add to business uncertainty

26 July 2019 - Medicines Australia supports efforts to strengthen Australia’s Intellectual Property arrangements to be consistent with international best ...

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'I owe it everything': cancer drug approval win for rare cancers

23 July 2019 - Paul Hazelwood was told there was nothing else doctors could do to treat his rare terminal ...

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Pharma giant using loophole to falsely promote opioid pain relief product across Australia

10 July 2019 - Debbie Thompson is a grandmother of five who likes to crochet in her spare time. The ...

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Schedule of fees and charges

2 July 2019 - 2019-20 fees and charges schedule applies to applications submitted to the TGA on or after 1 July ...

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International work-sharing Initiative - niraparib (Zejula)

1 July 2019 - The TGA has approved a new drug for the treatment of some ovarian, fallopian tube, or ...

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Cost recovery implementation statement

21 June 2019 - The cost recovery implementation statement outlines the TGA's regulatory costs and provides detailed information on TGA's ...

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Ingredient name changes: a medicine ingredient by any other name…

11 June 2019 - Consistent names are important, especially the names we use for important things like medicine ingredients. ...

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TGA fees and charges: summary from 1 July 2019

23 May 2019 - The TGA is required to recover its costs for all activities that fall within the scope ...

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South Africa's Aspen sells Australian prescription portfolio to Mylan

20 May 2019 - Aspen Pharmacare has said that Mylan had exercised an option to buy the South African drug ...

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Sigma Healthcare leadership says it has received no worker reports of medicine mishandling

16 May 2019 - Sigma Healthcare's chief executive Mark Hooper has told investors that the company takes its obligations to ...

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Sigma Healthcare to face investor questions over claims it mishandled prescription drugs

15 May 2019 - Pharmaceutical supplier Sigma Healthcare will face shareholder questions over claims that it failed to properly handle ...

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Medicines Australia welcomes ALP R&D investment pledge

8 May 2019 - Medicines Australia welcomes today’s announcement from the Australian Labor Party to reform the Research and Development ...

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Newly approved MS drug to offer relief to children

1 May 2019 - A wonder drug to treat children with multiple sclerosis has been approved for use in Australia. ...

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