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 31 Mar 2022
PHARMAC secures advance purchase agreement for a pre-exposure COVID-19 treatment
31 March 2022 - PHARMAC has negotiated an agreement with AstraZeneca for its pre-exposure prophylactic COVID-19 treatment, which would be targeted ...
Posted by Michael Wonder on 31 Mar 2022
2022 April cycle - brand price reductions and savings to patients
31 March 2022 - Brand price reductions and savings to patients resulting from the 2022 April cycle of price disclosure have ...
Posted by Michael Wonder on 30 Mar 2022
Pfizer’s oral COVID-19 treatment arrives in New Zealand
31 March 2022 - The first shipment of Pfizer’s new oral antiviral treatment for COVID-19, Paxlovid, has arrived in New ...
Posted by Michael Wonder on 30 Mar 2022
FDA officials aim to stop misuse of the term ‘digital biomarker’
29 March 2022 - While a lot of researchers claim they are capturing digital biomarker data, they may in fact be ...
Posted by Michael Wonder on 30 Mar 2022
Roche, Government miss deadline for Tecentriq reimbursement talks
30 March 2022 - Roche Korea and the Government failed to reach an agreement over the reimbursement rate of Tecentriq ...
Posted by Michael Wonder on 30 Mar 2022
U.S. FDA accepts for priority review Taiho Oncology's new drug application for futibatinib for cholangiocarcinoma
30 March 2022 - Taiho Oncology and Taiho Pharmaceutical announced today that the U.S. FDA has accepted for priority review the ...
Posted by Michael Wonder on 30 Mar 2022
Akebia Therapeutics receives complete response letter from the FDA for vadadustat for the treatment of anaemia due to chronic kidney disease in adult patients
30 March 2022 - Akebia Therapeutics today announced that the U.S. FDA has issued a complete response letter to Akebia's ...
Posted by Michael Wonder on 30 Mar 2022
ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for virologically suppressed adolescents living with HIV who are 12 years of age or older and weigh at least 35 kg
29 March 2022 - The expanded indication for the first and only complete long-acting HIV regimen provides an option with as ...
Posted by Michael Wonder on 30 Mar 2022
EMA starts rolling review of COVID-19 vaccine HIPRA (PHH-1V)
29 March 2022 - EMA’s CHMP has started a rolling review of COVID-19 Vaccine HIPRA (also known as PHH-1V). ...
Posted by Michael Wonder on 30 Mar 2022
Enanta Pharmaceuticals receives FDA fast track designation for EDP-235, its oral 3CL protease inhibitor specifically designed for the treatment and prevention of COVID-19
29 March 2022 - Enanta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for EDP-235, its ...
Posted by Michael Wonder on 30 Mar 2022
Tagraxofusp for treating blastic plasmacytoid dendritic cell neoplasm
30 March 2022 - Tagraxofusp is human interleukin-3 genetically conjugated to diphtheria toxin protein. ...
Posted by Michael Wonder on 30 Mar 2022
MSAC publishes agenda for July 2022 meeting
30 March 2022 - 12 agenda items for consideration at the 28-29 July 2022 meeting. ...
Posted by Michael Wonder on 30 Mar 2022
ImmunoGen submits biologics license application to the US Food and Drug Administration for mirvetuximab soravtansine in ovarian cancer
29 March 2022 - Submission based on positive results from pivotal Phase 3 SORAYA trial. ...
Posted by Michael Wonder on 30 Mar 2022
Government hopes to hook voters with cheaper drugs
29 March 2022 - Patients will get access to cheaper or free medicines sooner under plans to reduce the PBS ...
Posted by Michael Wonder on 30 Mar 2022
Drug trials a ‘ticking time bomb’: ex-TGA agent
28 March 2022 - A former TGA official who led the regulator’s inspections program has warned that a lack of ...