Blog
RSS FeedPosted by Michael Wonder on 05 Dec 2024
Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan approved for marketing by NMPA of China for second-line advanced or metastatic triple negative breast cancer
27 November 2024 - Sichuan Kelun-Biotech Biopharmaceutical announced that the Company received marketing authorisation in China from the NMPA for the ...
Posted by Michael Wonder on 05 Dec 2024
Lin BioScience receives US FDA fast track designation for LBS-007
27 November 2024 - A Phase 1/2 trial in patients with relapsed or resistant acute leukaemias is on-going. ...
Posted by Michael Wonder on 05 Dec 2024
Exelixis provides regulatory update related to supplemental new drug application for cabozantinib (Cabometyx) for the treatment of patients with previously treated advanced neuroendocrine tumors
26 November 2024 - 26, 2024-- Exelixis today announced that the US FDA has notified the company that the supplemental new ...
Posted by Michael Wonder on 05 Dec 2024
European Commission approves BeiGene’s Tevimbra for first-line treatment of advanced/metastatic oesophageal squamous cell carcinoma and gastric or gastro-oesophageal junction cancer
27 November 2024 - New indications based on two Phase 3 studies demonstrating statistically significant overall survival benefit for patients ...
Posted by Michael Wonder on 04 Dec 2024
Novartis Kisqali receives European Commission approval in a broad population of patients with HR positive/HER2 negative early breast cancer at high risk of recurrence
27 November 2024 - Approval is based on Phase 3 NATALEE data showing Kisqali (ribociclib) plus adjuvant endocrine therapy demonstrated clinically ...
Posted by Michael Wonder on 03 Dec 2024
New Zealand Pharmaceutical Schedule - 1 December 2024
1 December 2024 - The December 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 03 Dec 2024
Preferences for speed of access versus certainty of the survival benefit of new cancer drugs: a discrete choice experiment
18 November 2024 - The extent to which patients with cancer are willing to accept uncertainty about the clinical benefit of ...
Posted by Michael Wonder on 03 Dec 2024
The trade-off between accelerated cancer drug approvals and patient preferences
18 November 2024 - Cancer care stands at a critical juncture where the urgency of rapid drug approvals must be balanced ...
Posted by Michael Wonder on 03 Dec 2024
Shorla Oncology announces FDA approval of Imkeldi (imatinib) oral solution, an oral liquid for the treatment of certain forms of leukaemia and other cancers
25 November 2024 - Imkeldi marks Shorla Oncology’s fourth FDA Approval. ...
Posted by Michael Wonder on 02 Dec 2024
Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma
25 November 2024 - Regulatory submission supported by Phase 3 head to head DREAMM-7 and DREAMM-8 trials showing statistically significant efficacy, ...
Posted by Michael Wonder on 02 Dec 2024
Gilead’s Trodelvy awaits re-deliberation for reimbursement in Korea following patient petitions, price cut proposal
25 November 2024 - The triple negative breast cancer treatment Trodelvy (sacituzumab govitecan), which drew 100,000 petitions from patients, will ...
Posted by Michael Wonder on 01 Dec 2024
Changes to the PBS listings for Opdualag and Vyxeos
1 December 2024 - As of 1 December 2024, combination chemotherapy medicines, Opdualag and Vyxeos, will be transitioned from the Highly ...
Posted by Michael Wonder on 01 Dec 2024
BC man calls on federal, provincial governments to cover his costly, life saving cancer treatment
30 November 2024 - Pharmaceutical company Novartis says a five dose treatment costs about $135K. ...
Posted by Michael Wonder on 30 Nov 2024
US FDA accepts supplemental new drug application for Nubeqa (darolutamide) for the treatment of patients with metastatic hormone sensitive prostate cancer
21 November 2024 - Submission based on positive results from the Phase 3 ARANOTE trial which showed Nubeqa (darolutamide) plus androgen ...
Posted by Michael Wonder on 30 Nov 2024
Health Canada authorises Carvykti (ciltacabtagene autoleucel) for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
21 November 2024 - Authorisation is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with ...