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 04 Apr 2023
Medicare non-compliance and fraud costing Australians
4 April 2023 - The Albanese Government has today released the findings of a review into the compliance system that underpins ...
Posted by Michael Wonder on 04 Apr 2023
PHARMAC seeking feedback on the COVID-19 anti-viral molnupiravir
4 April 2023 - PHARMAC are consulting on the role of molnupiravir in New Zealand’s portfolio of COVID-19 treatments. ...
Posted by Michael Wonder on 04 Apr 2023
Koselugo approved in Canada for paediatric patients with neurofibromatosis type 1 plexiform neurofibromas
3 April 2023 - First and only therapy approved to treat this rare and debilitating genetic condition. ...
Posted by Michael Wonder on 04 Apr 2023
HUTCHMED completes rolling submission of NDA to US FDA for fruquintinib for the treatment of refractory metastatic colorectal cancer
31 March 2023 - NDA supported by data from global Phase 3 FRESCO-2 study in the US, Europe, Japan and Australia ...
Posted by Michael Wonder on 04 Apr 2023
Chiesi Global Rare Diseases announces approval of Ferriprox MR deferiprone extended release tablets in Canada
31 March 2023 - New formulation allows twice-daily dosing in patients with transfusional iron overload due to thalassaemia syndromes when ...
Posted by Michael Wonder on 03 Apr 2023
FDA grants accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial carcinoma
3 April 2023 - Today, the FDA granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) ...
Posted by Michael Wonder on 03 Apr 2023
Medicare system is ‘not fit for purpose’, review finds
4 April 2023 - Australia’s health funding system is “fragmented and disjointed” and in critical need of being simplified, says ...
Posted by Michael Wonder on 03 Apr 2023
Nucala (mepolizumab) is now listed on the PBS for Australians with chronic rhinosinusitis with nasal polyps
3 April 2023 - Nucala is the first biologic treatment to be PBS-subsidised for the treatment of severe chronic rhinosinusitis with ...
Posted by Michael Wonder on 03 Apr 2023
Vertex and CRISPR Therapeutics complete submission of rolling biologics license applications to the US FDA for exa-cel for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
3 April 2023 - EU and UK filings completed in 2022; submissions validated by EMA and MHRA and the review ...
Posted by Michael Wonder on 03 Apr 2023
Sandoz receives approval by European Commission for Hyrimoz (adalimumab) high-concentration formulation
3 April 2023 - Biosimilar Hyrimoz (adalimumab) citrate free high concentration formulation is now approved in the EU for use in ...
Posted by Michael Wonder on 03 Apr 2023
Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with neuromyelitis optica spectrum disorder
3 April 2023 - No relapses observed in pivotal trial of first and only long-acting C5 inhibitor, indicating potential to ...
Posted by Michael Wonder on 03 Apr 2023
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...
Posted by Michael Wonder on 02 Apr 2023
Pixium Vision announces FDA breakthrough device designation for the Prima System in dry AMD
31 March 2023 - PRIMAvera European pivotal trial in dry AMD fully recruited and on track to report primary endpoints around ...
Posted by Michael Wonder on 02 Apr 2023
Mitsubishi Tanabe Pharma Canada receives engagement letter from Pan-Canadian Pharmaceutical Alliance for Radicava oral suspension
31 March 2023 - Mitsubishi Tanabe Pharma Canada is pleased to announce the company has entered into negotiations with the ...
Posted by Michael Wonder on 02 Apr 2023
Samsung Bioepis receives positive CHMP opinion for eculizumab biosimilar, Epysqli
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...