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 Feb 2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
31 January 2023 - From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via ...
Posted by Michael Wonder on 31 Jan 2023
US health care from a global perspective, 2022: accelerating spending, worsening outcomes
31 January 2023 - In the previous edition of US Health Care from a Global Perspective, we reported that people ...
Posted by Michael Wonder on 31 Jan 2023
Jazz Pharmaceuticals receives NICE recommendation for the reimbursement of Epidyolex (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex in England
31 January 2023 - Jazz Pharmaceuticals today announced that Epidyolex (cannabidiol 100 mg/mL oral solution), developed by GW Pharmaceuticals, has been ...
Posted by Michael Wonder on 31 Jan 2023
A watershed year for biosimilars — if regulators and policy makers step up
31 January 2023 - 31 January is set to mark the start of a watershed year for the biosimilars industry ...
Posted by Michael Wonder on 31 Jan 2023
Schedule of Pharmaceutical Benefits - 1 February 2023
1 February 2023 - The February 2023 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Jan 2023
Ionis receives FDA fast track designation for olezarsen in patients with familial chylomicronaemia syndrome
31 January 2023 - If approved, olezarsen would be the first approved treatment for familial chylomicronaemia syndrome in the US. ...
Posted by Michael Wonder on 31 Jan 2023
New Zealand Pharmaceutical Schedule - 1 February 2023
1 February 2023 - The February 2023 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 Jan 2023
Reneo Pharmaceuticals receives fast track designation from the FDA for mavodelpar (REN001) in a genotype of long-chain fatty acid oxidation disorder
31 January 2023 - Reneo Pharmaceuticals today announced that the US FDA has granted mavodelpar (REN001) fast track designation for long ...
Posted by Michael Wonder on 31 Jan 2023
Amjevita (adalimumab-atto), first biosimilar to Humira, now available in the United States
31 January 2023 - Four years of real world experience in more than 300,000 patients and over 60 countries. ...
Posted by Michael Wonder on 31 Jan 2023
Call for Enhertu to be registered on Pharmaceutical Benefits Scheme
31 January 2023 - Sarah Lee has been forced to use her super and life insurance to pay for the treatment. ...
Posted by Michael Wonder on 31 Jan 2023
International price comparison of medicines (2022)
31 January 2023 - The price of prescription drugs in Sweden has fallen compared to other countries since 2014 and is ...
Posted by Michael Wonder on 31 Jan 2023
Association between pre-approval confirmatory trial initiation and conversion to traditional approval or withdrawal in the FDA accelerated approval pathway
27 January 2023 - The accelerated approval pathway allows the US FDA to approve drugs that demonstrate an effect on a ...
Posted by Michael Wonder on 31 Jan 2023
Distribution markups and taxes for prescription pharmaceuticals: do we see the complete picture of the pharmaceutical price?
30 January 2023 - An analysis presented at the ISPOR Europe 2021 conference highlighted considerable variability across countries in how much ...
Posted by Michael Wonder on 31 Jan 2023
FDA may not always require post-approval trials to be enrolled before accelerated approvals
30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...
Posted by Michael Wonder on 31 Jan 2023
Options for a reformed Prostheses List pre-listing assessment framework and governance structure
31 January 2023 - This report provides a framework and proposes options for governance that would align the Prostheses List processes ...