Submissions to the March 2025 PBAC meeting

24 October 2024 - The Department of Health and Aged Care has received notification that pharmaceutical companies plan to bring ...

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IntraBio announces US FDA accepts new dug application for IB1001 for the treatment of Niemann-Pick disease type C

26 March 2024 - PDUFA date set for 24 September 2024. ...

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Pembrolizumab in combination with platinum-based chemotherapy for treating recurrent, persistent or metastatic cervical cancer

5 October 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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Nomination for an early re-entry resubmission - what exactly does it mean?

12 September 2022 - We compare and contrast the submissions nominated by the PBAC in March for an early re-entry ...

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New drug application resubmission

31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...

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National Medicines Policy Review – publication of submissions

21 January 2022 - On 30 August 2021, the National Medicines Policy Review Committee invited submissions to support the Review of ...

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Application for cystic fibrosis medicine received by PHARMAC

9 July 2021 - PHARMAC is starting its funding assessment process for a new cystic fibrosis medication after receiving an ...

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DoH publishes revised agenda for July 2021 PBAC meeting

6 July 2021 - Agenda revised on the eve of next scheduled meeting. ...

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European Medicines Agency validates Bristol Myers Squibb’s application for Zeposia (ozanimod) for the treatment of ulcerative colitis

28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...

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Health products portal – intent to apply

14 November 2019 - The Department of Health (the Department) has been working to digitise and simplify the PBS submission ...

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Application process changes for access to Section 100 - Highly Specialised Drugs medicines

25 July 2019 - From 1 August 2019, hospital authorities will no longer be required to seek separate approval from ...

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PHARMAC publishes list of applications to be considered by PTAC later this month

14 May 2019 - The list includes a number of medicines for patients with breast cancer. ...

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Bayer completes rolling submission for darolutamide in U.S.

27 February 2019 - Bayer today announced the completion of the rolling submission of a new drug application for darolutamide to ...

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PBAC - 2018 in review

7 January 2019 - The PBAC considered 195 submissions in 2018; 173 were considered by the PBAC in 2017. ...

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Treatment for families battling a devastating rare disease

3 May 2018 - New Zealand infants suffering from a rare neuromuscular condition may soon be eligible for compassionate access ...

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