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 18 Mar 2022
Update to the statutory scheme to control the costs of branded health service medicines
15 March 2022 - The UK Government is seeking views on its proposal to increase the rate of payments made ...
Posted by Michael Wonder on 18 Mar 2022
Moderna submits amendment to the emergency use authorisation for an additional booster dose of its COVID-19 vaccine in the U.S.
17 March 2022 - Moderna today announced that it has submitted a request to the U.S. FDA for an amendment ...
Posted by Michael Wonder on 18 Mar 2022
Marinus Pharmaceuticals announces FDA approval of Ztalmy (ganaxolone) for CDKL5 deficiency disorder
18 March 2022 - Rare paediatric disease priority review voucher awarded to Marinus Pharmaceuticals by the FDA. ...
Posted by Michael Wonder on 18 Mar 2022
Public summary documents – November 2021 PBAC meeting (first time rejections and deferrals)
18 March 2022 - The Public Summary Documents (first time rejections and deferrals) from the November 2021 PBAC meeting are now ...
Posted by Michael Wonder on 18 Mar 2022
Australian cancer patients to get improved access to clinical trials
17 March 2022 - Australian cancer patients will get improved access to local clinical trials through a new public-private partnership ...
Posted by Michael Wonder on 17 Mar 2022
Health Canada authorises Moderna's COVID-19 vaccine in children (6-11 years)
17 March 2022 - Announcement follows recent authorisation of the Company's mRNA COVID-19 vaccine in Australia and the European Union ...
Posted by Michael Wonder on 17 Mar 2022
Panel scrutinises quick FDA drug approvals
17 March 2022 - A House committee will spotlight an FDA process that’s been criticised as putting some of the ...
Posted by Michael Wonder on 17 Mar 2022
Agreement reached on funding reforms for medical devices
17 March 2022 - The Medical Technology Association of Australia has signed a joint four-year agreement with the Commonwealth Government ...
Posted by Michael Wonder on 17 Mar 2022
Reforms to deliver lower prices for medical devices and lower private health insurance premiums
17 March 2022 - The Australian Government’s plan to make private health insurance simpler and more affordable for all Australians is ...
Posted by Michael Wonder on 17 Mar 2022
Backing life-saving local cancer drug development
17 March 2022 - Joint media release with the Minister for Health and Aged Care the Hon Greg Hunt MP. ...
Posted by Michael Wonder on 17 Mar 2022
‘Keytruda reimbursement provides global standard care for Korean lung cancer patients’
17 March 2022 - MSD’s Keytruda (pembrolizumab) became reimbursable for the first-line treatment of non-small-cell lung cancer in March, enabling ...
Posted by Michael Wonder on 17 Mar 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for EGFR therapeutics targeting exon 19 deletions or exon 21 substitutions in non-small cell lung cancer
17 March 2022 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved ...
Posted by Michael Wonder on 17 Mar 2022
Aquestive Therapeutics receives FDA fast track designation for AQST-109 for emergency treatment of allergic reactions including anaphylaxis
17 March 2022 - Aquestive Therapeutics today announced that the U.S. FDA has granted fast track designation to AQST-109, the first ...
Posted by Michael Wonder on 17 Mar 2022
Evusheld approved to prevent COVID-19 in people whose immune response is poor
17 March 2022 - The decision to grant approval for this treatment was endorsed by the Government’s independent expert scientific advisory ...
Posted by Michael Wonder on 17 Mar 2022
ICER publishes evidence report on novel agents to prevent chemotherapy-induced neutropenia and other myelosuppressive effects
17 March 2022 - Due to the FDA action on plinabulin, ICER will not hold a public meeting but has produced ...