Publication of Stage 1 and Stage 2 PBS Process Improvements metrics report for 2022-23

19 April 2024 - The 2022-23 Stage 1 and Stage 2 PBS process improvements metrics report is now available on ...

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Updates to the HTA Policy and Methods Review Reference Committee (15 April 2024)

15 April 2024 - The HTA Review Reference Committee is finalising its report and recommendations to the Australian Government having ...

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Waiting for new medicines in Canada, Europe, and the United States: study finds Americans get better and faster access to innovative drugs

11 April 2024 - A recent study published by the Canadian Health Policy Institute examined the availability and wait times ...

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New target zero initiative aims to help improve access to new drugs

9 April 2024 - Target Zero is a new initiative that aims to improve the time to access for patients ...

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Patient advocates clash over wisdom of ‘approving drugs faster and faster’

26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...

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Deliberations at the CHMP regarding the marketing authorisation application in the EU for lecanemab have been rescheduled due to procedural reasons at the EMA

22 March 2024 - Eisai announced today that the oral explanation scheduled for 19 March at the CHMP for lecanemab, ...

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Zevra Therapeutics provides FDA update on the PDUFA action date for arimoclomol as a treatment for Niemann-Pick disease type C

4 March 2024 - The new PDUFA action date set by the FDA is 21 September 2024. ...

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Minister announces parallel assessment means new medicines assessed sooner

28 February 2024 - PHARMAC is changing its process so it can assess a funding application at the same time Medsafe ...

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Rocket Pharmaceuticals announces update on FDA review timeline of Kresladi (marnetegragene autotemcel) for the treatment of severe leukocyte adhesion deficiency-I

13 February 2024 - New Prescription Drug User Fee Act date of 30 June 2024. ...

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Liquidia provides update on new drug application for Yutrepia (treprostinil) inhalation powder

25 January 2024 - Liquidia announced today that the US FDA provided an update on its review of the new drug ...

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Theratechnologies receives update from FDA on tesamorelin F8 supplemental biologics license application

23 January 2024 - FDA continues to review the file past the Prescription Drug User Fee Act goal date of ...

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Medicines lobby says the PBS has not kept up with advances — or approvals — in medicines

8 December 2023 - Little Jack Roche was five weeks old when diagnosed with cystic fibrosis. The medication that could help ...

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Italfarmaco Group announces new PDUFA date for givinostat DMD NDA

29 November 2023 - Italfarmaco Group announced today that the US FDA has extended the review process of the n ...

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Updates to the HTA Policy and Methods Review Reference Committee (1 December 2023)

1 December 2023 - To ensure that the Reference Committee has sufficient time to consider the extensive and valuable input ...

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New frontier will lead to better health outcomes

30 November 2023 - The Government has today tabled its response to an inquiry considering how to give Australian patients timely ...

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