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 30 Jun 2022
New strategic agreements with the medicines industry – PBS website updates
1 July 2022 - Amendments made by the National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Act 2021 give effect to ...
Posted by Michael Wonder on 30 Jun 2022
Schedule of Pharmaceutical Benefits - 1 July 2022
1 July 2022 - The July 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 30 Jun 2022
Aura Biosciences receives FDA fast track designation for belzupacap sarotalocan (AU-011) for the treatment of non-muscle invasive bladder cancer
30 June 2022 - Aura Biosciences today announced that the U.S. FDA has granted fast track designation for belzupacap sarotalocan (AU-011), ...
Posted by Michael Wonder on 30 Jun 2022
Revlimid maintenance therapy passes reimbursement review
30 June 2022 - Revlimid maintenance therapy to treat multiple myeloma passed the health insurance review agency’s reimbursement review four ...
Posted by Michael Wonder on 30 Jun 2022
Pfizer announces submission of new drug application to the U.S. FDA for Paxlovid
30 June 2022 - Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalisations or death from ...
Posted by Michael Wonder on 30 Jun 2022
Update to continued dispensing arrangements
30 June 2022 - From 1 July 2022, on-going continued dispensing arrangements have been expanded to include additional medicines groups to ...
Posted by Michael Wonder on 30 Jun 2022
Review into COVID-19 vaccine and treatment purchases
30 June 2022 - The Australian Government is undertaking an independent review of Australia’s vaccine and treatment procurements, led by former ...
Posted by Michael Wonder on 30 Jun 2022
From FDA to MHRA: are drug regulators for hire?
29.June 2022 - Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit ...
Posted by Michael Wonder on 30 Jun 2022
Zanubrutinib for the treatment of adults with Waldenström’s macroglobulinaemia
29 June 2022 - NICE has published a second appraisal consultation document on the use of zanubrutinib for the treatment ...
Posted by Michael Wonder on 30 Jun 2022
Akeso's cadonilimab (PD-1/CTLA-4), the first dual immune checkpoint inhibitor to treat cancer, approved for marketing in China
29 June 2022 - Globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing. ...
Posted by Michael Wonder on 30 Jun 2022
Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 6 months up to 5 years
30 June 2022 - On 28 June 2022, the TGA granted a provisional determination to Pfizer Australia in relation to ...
Posted by Michael Wonder on 29 Jun 2022
Patient focused drug development: selecting, developing, or modifying fit for purpose clinical outcome assessments
29 June 2022 - This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) ...
Posted by Michael Wonder on 29 Jun 2022
Clinical benefit and expedited approval of cancer drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
22 June 2022 - Regulatory agencies have sought to speed up the review of new cancer medicines and reduce delays in ...
Posted by Michael Wonder on 29 Jun 2022
Sanofi caps out of pocket insulin cost at $35 for uninsured U.S. patients
29 June 2022 - French drug maker Sanofi said on Wednesday uninsured diabetes patients in the United States will pay ...
Posted by Michael Wonder on 29 Jun 2022
Breaking the rule of drug pricing In America
29 June 2022 - Having worked in healthcare most of my life, very little surprises me. But four years ago, ...