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Category Archives: Life Sciences Industry

Relating to the Life Sciences Industry in general

Are you ready for the mandatory transition to eCTD for prescription medicines?

In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new … Continue reading

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November 2018 PBAC Meeting Agenda

The November 2018 PBAC Meeting is scheduled to conclude today. Here, the Commercial Eyes Market Access team provides an analysis of the meeting agenda, including Sponsors with multiple submissions and the nature of requested listings by type.     The … Continue reading

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PBAC Meeting Outcomes – July 2018

The July 2018 PBAC Meeting Outcomes were published on 17th August 2018. With 64 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making, including additional analysis conducted on biosimilar and oncology submissions.   … Continue reading

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Public Submissions to the August 2018 PBAC Special Meeting – Part 2

In the second part of this two-part series (Read Part 1 about here) we bring you further insight into opinions from the public submissions to the August 2018 PBAC Special Meeting. Opinions from the Public Submissions Outcomes of the PBAC’s … Continue reading

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Sponsors struggle with Ministerial discretion

The 2017 Medicines Australia Strategic Agreement with the Australian Government extended the existing five-year anniversary statutory price reduction (SPR) of 5% for F1 medicines and introduced new SPRs for drugs that have been listed for ten years and fifteen years … Continue reading

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The long road to PBS listing for Orkambi

Orkambi (lumacaftor and ivacaftor), a treatment for cystic fibrosis (CF), will go before the PBAC for a fourth time at the upcoming July 2018 PBAC meeting. So far, the road to reimbursement has been filled with multiple rejections, a strong … Continue reading

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PBAC Meeting Agenda – July 2018

The July 2018 PBAC Meeting is scheduled from 4 to 6 Jul 2018. Here, the Commercial Eyes Market Access team provides an overview of the meeting agenda, including submissions relating to biosimilars lodged for this meeting.     The Commercial … Continue reading

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PBAC Meeting Outcomes – March 2018

The March 2018 PBAC Meeting Outcomes were published on 20th April 2018. With 71 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making, including an additional analysis conducted on oncology submissions which have … Continue reading

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Life Saving Drugs Program: new lease on life, or on life support?

Last week saw the release of the final report of the post-market review into the Life Saving Drugs Program (LSDP), including a response to the report released by the Australian Government. The Life Saving Drugs Program currently provides subsidised access … Continue reading

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What is Happening with the Provisional Approval Pathway?

We’ve come a long way When the independent review of medicines and medical devices regulation was announced in October 2014, the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription medicines. A provisional approval pathway would allow … Continue reading

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