Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 25 Nov 2021
MTAA welcomes new frontiers report
25 November 2021 - The Medical Technology Association of Australia wishes to thank Trent Zimmerman MP and Dr Mike Freelander MP ...
Posted by Michael Wonder on 25 Nov 2021
Bristol Myers Squibb receives European Commission approval of Zeposia (ozanimod) for use in adults with moderately to severely active ulcerative colitis
23 November 2021 - Zeposia approval is based on the Phase 3 True North trial, which demonstrated clinically meaningful improvements ...
Posted by Michael Wonder on 25 Nov 2021
COVID-19 vaccine weekly safety report (25 November 2021)
25 November 2021 - To 21 November 2021, the TGA has received 341 reports which have been assessed as likely to ...
Posted by Michael Wonder on 25 Nov 2021
A divisive ruling on devices — Genus Medical Technologies v. FDA
24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. ...
Posted by Michael Wonder on 25 Nov 2021
MSAC publishes agenda for upcoming meeting
24 November 2021 - 10 agenda items for consideration at the 31 March - 1 April 2022 meeting. ...
Posted by Michael Wonder on 25 Nov 2021
Medicines Australia welcomes tabling of parliamentary report about approval processes for new drugs and novel medical technologies
25 November 2021 - Medicines Australia welcomes the House of Representatives Health, Aged Care and Sport Committee Inquiry report into ...
Posted by Michael Wonder on 24 Nov 2021
ICER to assess gene therapy for beta thalassaemia
24 November 2021 - Report will be subject of New England CEPAC meeting in June 2022; draft scoping document open ...
Posted by Michael Wonder on 24 Nov 2021
COVID windfall continues for corporate insurers
24 November 2021 - Corporate insurers collected a staggering $1.8 billion in profits over the past year by collecting more in ...
Posted by Michael Wonder on 24 Nov 2021
Germany's Government to be eyes backdated drug price cuts
24 November 2021 - Germany's prospective three-party government plans to cut prices retroactively for recently-launched prescription drugs to keep health ...
Posted by Michael Wonder on 24 Nov 2021
Trodelvy (sacituzumab govitecan) granted European Commission marketing authorisation for treatment of metastatic triple negative breast cancer in second line
23 November 2021 - Marketing authorisation based on Phase 3 ASCENT study showing Trodelvy significantly improved overall survival versus physician’s choice ...
Posted by Michael Wonder on 24 Nov 2021
A vision for use of real world evidence in EU medicines regulation
24 November 2021 - Enabling the use of real world evidence and establishing its value for regulatory decision-making on the development, ...
Posted by Michael Wonder on 24 Nov 2021
The FDA's dysfunction is a public health crisis of its own
22 November 2021 - Earlier this month, President Biden tapped Dr. Robert Califf to lead the FDA. ...
Posted by Michael Wonder on 24 Nov 2021
COVID-19 vaccine indemnity
24 November 2021 - The Australian Government is reducing the claim threshold of the no fault COVID-19 Vaccine Claims Scheme to ...
Posted by Michael Wonder on 24 Nov 2021
Agenda for the March 2022 PBAC meeting
24 November 2021 - The agenda for the March 2022 PBAC meeting is now available. ...
Posted by Michael Wonder on 24 Nov 2021
Review of real world evidence and patient reported outcomes
24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...