Blog
RSS FeedPosted by Michael Wonder on 14 May 2025
EMA starts review of Ixchiq (live attenuated chikungunya vaccine)
7 May 2025 - The vaccine must not be used in people 65 years and above while review is underway. ...
Posted by Michael Wonder on 02 Mar 2025
Authorisations of human medicinal products with a new active substance and additional indications 2024
28 February 2025 - 46 human medicinal products with new active substances authorised. ...
Posted by Michael Wonder on 19 Jan 2025
Human medicines in 2024
16 January 2025 - In 2024, EMA recommended 114 medicines for marketing authorisation. ...
Posted by Michael Wonder on 28 Dec 2024
Utilisation analysis of heart failure medicines listed on the PBS
20 December 2024 - At its September 2024 meeting, the PBAC considered a report presenting a utilisation analysis of PBS ...
Posted by Michael Wonder on 12 Dec 2024
Outcome statements for October 2024 stakeholder meetings: oral contraceptives and migraine
9 December 2024 - The Outcome Statements are now available for the Oral Contraceptives Stakeholder Meeting held on 10 October 2024 ...
Posted by Michael Wonder on 03 Dec 2024
HTA Policy and Methods Review update
3 December 2024 - The Minister for Health and Aged Care, the Hon Mark Butler MP has announced the Implementation Advisory ...
Posted by Michael Wonder on 16 Nov 2024
Outcome statement - October 2024 DUSC meeting
15 November 2024 - The outcome statement from the October 2024 DUSC meeting is now available. ...
Posted by Michael Wonder on 11 Sep 2024
HTA review outlines First Nations, pediatric reform and quick, cheap medicine
10 September 2024 - A Government review of Australia’s systems for accessing medicine has said it could slash waiting times ...
Posted by Michael Wonder on 11 Sep 2024
Final reports of the HTA Policy and Methods Review and Enhanced Consumer Engagement Process
10 September 2024 - The reports of the HTA Review and the Enhanced Consumer Engagement Process have been published. ...
Posted by Michael Wonder on 10 Jul 2024
Updates to the HTA Policy and Methods Review
10 July 2024 - The Health Technology Assessment (HTA) Policy and Methods Review concluded on 4 May 2024. The HTA ...
Posted by Michael Wonder on 06 Jul 2024
Four decades of orphan drugs and priorities for the future
6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...
Posted by Michael Wonder on 03 Jul 2024
The rare paediatric disease voucher program creates new treatments. I have new data to prove it.
2 July 2024 - The FDA’s rare paediatric disease priority review voucher program, which has been providing incentives for lifesaving innovations ...
Posted by Michael Wonder on 05 Jun 2024
ICER publishes protocol for annual assessment of drug coverage policies that present barriers to fair access
5 June 2024 - This year’s analysis will include the top ten commercial formularies by covered lives, and include drugs ...
Posted by Michael Wonder on 31 May 2024
Annual report highlights progress in science, medicines and health in 2023
30 May 2024 - EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the ...
Posted by Michael Wonder on 07 May 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...