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
Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular oedema
28 March 2022 - The bispecific antibody inhibits two disease pathways that drive nAMD and DME by blocking angiopoietin-2 (Ang-2) and ...
Posted by Michael Wonder on 31 Mar 2022
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice
31 March 2022 - EMA, in collaboration with the European Organisation for Research and Treatment of Cancer, has launched the Cancer ...
Posted by Michael Wonder on 31 Mar 2022
Agenda for July 2022 PBAC meeting
1 April 2022 - 30 March 2022 - The agenda for the July 2022 PBAC meeting is now available. ...
Posted by Michael Wonder on 31 Mar 2022
Chugai obtains regulatory approval for Perjeta and Herceptin for additional indication of HER2 positive colorectal cancer
28 March 2022 - Combination therapy of Perjeta and Herceptin obtained regulatory approval for advanced or recurrent HER2 positive colon cancer ...
Posted by Michael Wonder on 31 Mar 2022
Schedule of Pharmaceutical Benefits - 1 April 2022
1 April 2022 - The April 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...
Posted by Michael Wonder on 31 Mar 2022
Novavax submits request to expand conditional marketing authorisation of COVID-19 vaccine in the European Union to adolescents (ages 12-17)
31 March 2022 - If granted, Nuvaxovid COVID-19 vaccine (recombinant, adjuvanted) would be the first protein-based option for adolescents aged ...
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 ...