Blog
RSS FeedPosted by Michael Wonder on 23 Jun 2022
Expediency versus efficacy: re-examining the FDA’s accelerated drug approval process
23 June 2022 - It was precisely 30 years ago, in 1992, that the FDA established the accelerated approval program ...
Posted by Michael Wonder on 23 Jun 2022
FDA explains when it will rescind breakthrough designations
23 June 2022 - The US FDA on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy ...
Posted by Michael Wonder on 15 Jun 2022
PHARMAC announces first round of medicine funding decisions following $191 million pharmaceutical budget increase
15 June 2022 - PHARMAC today announces the first round of changes to medicines funding following its $191 million pharmaceutical ...
Posted by Michael Wonder on 09 Jun 2022
The days of the independent republic of PHARMAC are far from over
9 June 2022 - When he announced the government’s response to the recent independent review of PHARMAC Health Minister Andrew Little ...
Posted by Michael Wonder on 05 Jun 2022
The FDA’s Pazdur on accelerated approval, single-arm studies and his own future
4 June 2022 - When cancer drugs granted accelerated approval in the U.S. later turn out not to benefit patients, the ...
Posted by Michael Wonder on 26 May 2022
From scientific discovery to covered treatments: understanding the payer perspective as a keystone to achieving high value care
26 May 2022 - The mission of the National Institutes of Health is to translate scientific discovery into health by designing ...
Posted by Michael Wonder on 25 May 2022
Target trial emulation for transparent and robust estimation of treatment effects for health technology assessment using real world data: opportunities and challenges
25 May 2022 - Evidence about the relative effects of new treatments is typically collected in randomised controlled trials. ...
Posted by Michael Wonder on 19 May 2022
Multiple funding proposals being considered by PHARMAC
19 May 2022 - PHARMAC has issued three consultations today on proposals to fund medicines for conditions including cancer, multiple sclerosis, ...
Posted by Michael Wonder on 09 May 2022
Choices that fail health and wellbeing
5 May 2022 - NICE's expert group RAPID C-19, set up to ‘to ensure safe and timely patient access to treatments ...
Posted by Michael Wonder on 05 May 2022
Real world evidence - where are we now?
4 May 2022 - Notwithstanding on-going confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 ...
Posted by Michael Wonder on 21 Apr 2022
Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?
21 April 2022 - On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of what ...
Posted by Michael Wonder on 04 Apr 2022
FDA shuts out its own experts in authorising another vaccine booster
3 April 2022 - Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics. ...
Posted by Michael Wonder on 09 Feb 2022
HIRA mulls therapeutic outcome based benefits for ultra-expensive drugs
9 February 2022 - Pharmaceutical industry officials are paying attention to how the Korean government will manage health insurance benefits ...
Posted by Michael Wonder on 07 Feb 2022
Analysis of consumer comments into PBAC decision-making (2014–9)
4 February 2022 - Our objective was to analyse and review consumer comments in the PBAC's decision-making process. ...
Posted by Michael Wonder on 03 Feb 2022
Addressing uncertainty in relative effectiveness assessments by HTA organisations
31 January 2022 - This study outlines the ways in which different health technology assessment organizations deal with uncertainty in relative ...