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 01 Sep 2022
What “negotiating” with Medicare means for drug makers: a mixture of price controls and actual negotiations
1 September 2022 - In the debate on the drug pricing provisions contained in the Inflation Reduction Act, critics call the ...
Posted by Michael Wonder on 01 Sep 2022
First adapted COVID-19 booster vaccines recommended for approval in the EU
1 September 2022 - The EMA’s CHMP has recommended authorising two vaccines adapted to provide broader protection against COVID-19. ...
Posted by Michael Wonder on 01 Sep 2022
Critical kidney disease medication listed on the PBS
1 September 2022 - A life changing treatment for chronic kidney disease will be made available to thousands of Australians through ...
Posted by Michael Wonder on 01 Sep 2022
Janssen's Stelara gets insurance benefits as first-line therapy for ulcerative colitis
1 September 2022 - Janssen Korea said its ulcerative colitis Stelara (ustekinumab) won health insurance benefits as the primary treatment ...
Posted by Michael Wonder on 01 Sep 2022
Antengene announces Xpovia included for reimbursement by the PBS in Australia for the treatment of patients with relapsed and/or refractory multiple myeloma
1 September 2022 - Xpovio (selinexor) is the first and only selective inhibitor of nuclear export (SINE) inhibitor approved by the ...
Posted by Michael Wonder on 01 Sep 2022
Availability of new medicines in the US and Germany (2004 - 2018)
30 August 2022 - In this cohort study comparing 599 medicine approvals in the US and Germany between 2004 and 2018, ...
Posted by Michael Wonder on 01 Sep 2022
ACE publishes another tranche of technology guidances (August 2022)
31 August 2022 - Six technology guidance documents were published yesterday. ...
Posted by Michael Wonder on 01 Sep 2022
PBS listing for ovarian cancer and kidney disease
1 September 2022 - From 1 September 2022, Australians will have access to new and expanded medicines on the Pharmaceutical Benefits ...
Posted by Michael Wonder on 31 Aug 2022
Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions
31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...
Posted by Michael Wonder on 31 Aug 2022
Amneal announces submission of new drug application to the US FDA for IPX203 for the treatment of Parkinson’s disease
31 August 2022 - IPX203 is a novel, extended-release oral formulation of carbidopa and levodopa that if approved, would offer patients ...
Posted by Michael Wonder on 31 Aug 2022
Governor Ron DeSantis announces lawsuit against Biden Administration’s reckless delay of Canadian Prescription Drug Importation Program
31 August 2022 - Today, Governor Ron DeSantis announced a lawsuit against the US FDA in response to their unreasonable delay ...
Posted by Michael Wonder on 31 Aug 2022
Kidney disease drug dapagliflozin added to Pharmaceutical Benefits Scheme
31 August 2022 - Lachlan Ross describes his more than a decade-long battle with kidney failure as "very long, and very ...
Posted by Michael Wonder on 31 Aug 2022
FDA authorises Moderna, Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose
31 August 2022 - Today, the US FDA amended the emergency use authorisations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech ...
Posted by Michael Wonder on 31 Aug 2022
Schedule of Pharmaceutical Benefits - 1 September 2022
1 September 2022 - The September 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Aug 2022
US FDA grants fast track designation for Longeveron’s Lomecel-B product for treatment of hypoplastic left heart syndrome in infants
31 August 2022 - New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting ...