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 May 2022
Medicare spending on drugs with accelerated approval
24 May 2022 - The U.S. FDA provides accelerated approval to drugs on the basis of surrogate end points deemed to ...
Posted by Michael Wonder on 25 May 2022
Target trial emulation for transparent and robust estimation of treatment effects for health technology assessment using real world data: opportunities and challenges
25 May 2022 - Evidence about the relative effects of new treatments is typically collected in randomised controlled trials. ...
Posted by Michael Wonder on 25 May 2022
Noveome Biotherapeutics receives rare paediatric disease designation and orphan drug designation for the treatment of necrotising enterocolitis in neonates
24 May 2022 - Noveome Biotherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation and orphan drug ...
Posted by Michael Wonder on 25 May 2022
Health economic assessment of Trodelvy in advanced triple negative breast cancer
23 May 2022 - TLV has produced a health economic assessment for the regions for the drug Trodelvy (sacituzumab govitecan). ...
Posted by Michael Wonder on 25 May 2022
'Intensive work' ongoing to give 35 children with cystic fibrosis access to life-changing drug
24 May 2022 - Health Minister Stephen Donnelly has said he wants to see the 35 children with cystic fibrosis ...
Posted by Michael Wonder on 25 May 2022
Elevation Oncology announces FDA fast track designation granted to seribantumab for the tumour agnostic treatment of solid tumours harbouring NRG1 gene fusions
25 May 2022 - Elevation Oncology today announced that the U.S. FDA has granted fast track designation to seribantumab for the ...
Posted by Michael Wonder on 25 May 2022
Servier announces FDA approval of Tibsovo (ivosidenib tablets) in combination with azacitidine for patients with newly diagnosed IDH1 mutated acute myeloid leukaemia
25 May 2022 - FDA approval based on data from the global, Phase 3 AGILE trial that demonstrated a statistically ...
Posted by Michael Wonder on 25 May 2022
New injectable immunotherapy treatment for rare form of triple negative breast cancer recommended by NICE
25 May 2022 - An estimated 100 people per year with triple negative breast cancer that has spread to other ...
Posted by Michael Wonder on 25 May 2022
Remake of National Health (Supply of Pharmaceutical Benefits – Under Co-payment Data and Claims for Payment) Rules 2022
25 May 2022 - The Department has recently remade the National Health (Claims and under co-payment data) Rules 2012, now ...
Posted by Michael Wonder on 25 May 2022
Bausch + Lomb receives Health Canada approval of Lumify redness reliever eye drops
24 May 2022 - Lumify is Canada's first and only over the counter eye drop with low dose brimonidine for ...
Posted by Michael Wonder on 25 May 2022
Expanded ATAGI recommendations on winter COVID-19 booster doses for people at increased risk of severe COVID-19
25 May 2022 - The Australian Technical Advisory Group on Immunisation (ATAGI) have expanded their recommendations on the use of additional ...
Posted by Michael Wonder on 25 May 2022
Review of discount rate in the PBAC Guidelines
25 May 2022 - The Commonwealth has entered into a new Strategic Agreement in relation to reimbursement, health technology assessment ...
Posted by Michael Wonder on 25 May 2022
Verrica receives complete response letter from the FDA for its NDA for VP-102
24 May 2022 - Verrica has been advised that pre-approval inspection was conducted at Sterling and is not aware of any ...
Posted by Michael Wonder on 25 May 2022
Kiwis with cystic fibrosis feel forced to move overseas for affordable treatment
25 May 2022 - More Kiwis with cystic fibrosis are moving abroad for treatment, knowing they will die sooner if ...
Posted by Michael Wonder on 24 May 2022
Blue Lake Biotechnology announces FDA fast track designation for BLB-201 intranasal RSV vaccine
24 May 2022 - Blue Lake Biotechnology today announced that the U.S. FDA has granted fast track designation for BLB-201, an ...