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
New Zealand Pharmaceutical Schedule -1 April 2022
1 April 2022 - The April 2022 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 31 Mar 2022
Outlook Therapeutics submits biologics license application to the U.S. Food and Drug Administration for ONS-5010 as a treatment for wet AMD
31 March 2022 - ONS-5010 / LYTENAVA (bevacizumab-vikg), if approved, expected to receive 12 years of marketing exclusivity. ...
Posted by Michael Wonder on 31 Mar 2022
Ono receives supplemental approval of Opdivo (nivolumab) for adjuvant treatment of urothelial carcinoma in Japan
28 March 2022 - Ono Pharmaceutical today announced that Ono has received a supplemental approval of Opdivo (nivolumab) in Japan for ...
Posted by Michael Wonder on 31 Mar 2022
New drug application resubmission
31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...
Posted by Michael Wonder on 31 Mar 2022
Statement from Rare Disorders NZ re Minister Little's comments on PHARMAC funding
31 March 2022 - Rare Disorders NZ is extremely frustrated to hear the Minister of Health this week dismiss the call ...
Posted by Michael Wonder on 31 Mar 2022
EMA starts review of Sanofi-GSK COVID vaccine application
30 March 2022 - The European Union's drug regulator has started reviewing Sanofi and its British partner GlaxoSmithKline's application seeking ...
Posted by Michael Wonder on 31 Mar 2022
ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV
30 March 2022 - The FDA approval of the first dispersible single tablet regimen containing dolutegravir increases age-appropriate treatment options ...
Posted by Michael Wonder on 31 Mar 2022
COVID-19 vaccine weekly safety report (31 March 2022)
31 March 2022 - To 27 March 2022, the TGA has received 509 reports which have been assessed as likely to ...
Posted by Michael Wonder on 31 Mar 2022
ASC Therapeutics receives key regulatory designations in U.S. and Europe to advance its second generation gene therapy for haemophilia A
29 March 2022 - ASC Therapeutics has received from the U.S. FDA the fast track designation for ASC618, a second-generation gene ...
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 ...