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RSS FeedPosted by Michael Wonder on 26 Aug 2025
Enhertu approved in Japan as first HER2 directed medicine for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
25 August 2025 - Based on DESTINY-Breast06 phase 3 trial results that showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 26 Aug 2025
Datroway approved in China for patients with previously treated metastatic HR positive, HER2 negative breast cancer
25 August 2025 - First approval in China for Daiichi Sankyo and AstraZeneca’s Datroway based on TROPIONBreast01 results showing 37% reduction ...
Posted by Michael Wonder on 26 Aug 2025
Rusfertide receives breakthrough therapy designation for treatment of erythrocytosis in patients with polycythemia vera
25 August 2025 - Breakthrough therapy designation complements rusfertide's orphan drug and fast track designations, which together confer multiple benefits to ...
Posted by Michael Wonder on 25 Aug 2025
Health Canada approves Roche’s Columvi (glofitamab) as the first bi-specific antibody in Canada for relapsed or refractory diffuse large B-cell lymphoma after initial therapy
21 August 2025 - Approval is based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a ...
Posted by Michael Wonder on 25 Aug 2025
European Commission approves tablet formulation of BeOne Medicines’ Brukinsa for all approved indications
21 August 2025 - Tablets will advance treatment simplicity and convenience to meet patient needs across Europe. ...
Posted by Michael Wonder on 25 Aug 2025
Bewildering PBAC decision a missed opportunity to ensure Australian cancer patients not left behind
23 August 2025 - MSD Australia & New Zealand is astonished that after eight years of dialogue and consideration, the ...
Posted by Michael Wonder on 25 Aug 2025
Recommendations made the PBAC – July 2025
22 August 2025 - The recommendations from the July 2025 PBAC meeting are now available. ...
Posted by Michael Wonder on 25 Aug 2025
Committee rejects application for medication Keytruda to be subsidised for Aussies with cancer
23 August 2025 - Australians with rare cancers like Natalie Willacy have just been handed a devastating hit, which could leave ...
Posted by Michael Wonder on 25 Aug 2025
Injectable form of Ocrevus for relapsing remitting multiple sclerosis recommended for PBS listing
22 August 2025 - This new form of ocrelizumab is given as an injection under the skin (subcutaneously), takes a much ...
Posted by Michael Wonder on 24 Aug 2025
New Alzheimer’s drug rejected for PBS listing, leaving patients to pay up to $80k a year
23 August 2025 - New Alzheimer’s drug rejected for PBS listing, leaving patients to pay up to $80k/year. ...
Posted by Michael Wonder on 22 Aug 2025
DoH publishes revised agenda for November 2025 PBAC meeting (version 2)
20 August 2025 - The DoH has published a revised agenda for the November 2025 PBAC meeting. ...
Posted by Michael Wonder on 22 Aug 2025
Leqvio advances toward broader access with agreement between Novartis and the pan-Canadian Pharmaceutical Alliance
21 August 2025 - Eligible Canadian patients with heterozygous familial hypercholesterolaemia are one step closer to publicly funded access to ...
Posted by Michael Wonder on 22 Aug 2025
Breakthrough life-extending combination treatment for advanced bladder cancer recommended by NICE
21 August 2025 - NICE has recommended a new first-line treatment for adults with advanced bladder cancer, marking a significant ...
Posted by Michael Wonder on 22 Aug 2025
Health Canada grants marketing authorisation for an additional indication of Bayer's Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer
21 August 2025 - Bayer is pleased to announce that Health Canada has granted marketing authorisation for its oral androgen receptor ...
Posted by Michael Wonder on 21 Aug 2025
Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first
20 August 2025 - According to a recent analysis, Japanese regulators have the shortest time to approval for new drugs compared ...