Category Archives: Life Sciences Industry
Relating to the Life Sciences Industry in general
Commercial Eyes Recruiting: Regulatory Associate
Experience it all! Pharma, Med Device, Industry leading companies, broad range of therapeutic areas… The role… The Regulatory Associate is responsible for the preparation and submission of a range of regulatory applications for Australia and New Zealand. The … Continue reading
commercial eyes recruiting: research analyst
Apply you research and analysis skills to build a commercial career in the Healthcare industry. The Role… As the Market Insight Research Analyst you will be responsible for undertaking technical research and data analysis to support the delivery of … Continue reading
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
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
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
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
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
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
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
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
