Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2020
Standardised redactions to Public Summary Documents – nominations open for participation in the final trial, and implementation from July 2020
5 March 2020 - The Department is now seeking nominations from sponsors with submissions due to be considered at the ...
Posted by Michael Wonder on 25 Feb 2020
ICER issues final report and policy recommendations on acute treatments for migraine
25 February 2020 - Evidence on new agents lasmiditan, ubrogepant, and rimegepant judged inadequate to demonstrate superiority over more affordable triptans. ...
Posted by Michael Wonder on 20 Feb 2020
ICER releases draft evidence report on therapies for cystic fibrosis
20 February 2020 - Public comment period now open until 18 March 2020; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 20 Feb 2020
Serving public health paramount in a successful 2019 for FDA’s generic drug program
19 February 2020 - Safe, effective, high-quality generic drugs play a vital role in the U.S. health care system. ...
Posted by Michael Wonder on 31 Jan 2020
PBAC Public Summary Documents - August 2019 intracycle meeting
31 January 2020 - All Public Summary Documents from the August 2019 PBAC intracycle meeting are now available. ...
Posted by Michael Wonder on 24 Jan 2020
ICER releases draft evidence report on therapies for sickle cell disease
23 January 2020 - ICER’s ongoing assessment emphasises that policy makers will need to consider, in addition to traditional measures ...
Posted by Michael Wonder on 20 Jan 2020
Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study
17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...
Posted by Michael Wonder on 10 Jan 2020
ICER releases evidence report on acute treatments for migraine
10 January 2020 - Lasmiditan, rimegepant, and ubrogepant all perform better than placebo, but evidence is not adequate to distinguish among ...
Posted by Michael Wonder on 09 Jan 2020
Human medicines: highlights of 2019
9 January 2020 - EMA has published a review of its key recommendations in 2019 on the authorisation and safety ...
Posted by Michael Wonder on 09 Jan 2020
ICER issues final report and policy recommendations on JAK inhibitors for rheumatoid arthritis
9 January 2020 - Despite upadacitinib reaching common thresholds for cost-effectiveness when compared to adalimumab, the independent appraisal committee’s votes on ...
Posted by Michael Wonder on 13 Dec 2019
PBS expenditure and prescriptions report 2018-19
13 December 2019 - The PBS Expenditure and Prescriptions Report 1 July 2018 to 30 June 2019 is now available. ...
Posted by Michael Wonder on 26 Nov 2019
ICER releases evidence report on JAK inhibitors to treat rheumatoid arthritis
26 November 2019 - Using adalimumab as the comparator, upadacitinib’s value-based price benchmark is between $44,000-$45,000 per year; at December 9 ...
Posted by Michael Wonder on 16 Nov 2019
PBAC Public Summary Documents - July 2019 meeting
15 November 2019 - The Public Summary Documents (first time rejections and deferrals) from the July 2019 PBAC meeting are now ...
Posted by Michael Wonder on 01 Nov 2019
PBAC Public Summary Documents - May 2019 meeting
1 November 2019 - The Public Summary Documents from the May 2019 PBAC intracycle meeting are now available. ...
Posted by Michael Wonder on 21 Oct 2019
Annual performance statistics report: July 2018 to June 2019
21 October 2019 - At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added ...