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RSS FeedPosted by Michael Wonder on 17 Nov 2024
Azurity Pharmaceuticals announces FDA approval of Danziten (nilotinib) tablets, the first and only nilotinib with no mealtime restrictions
14 November 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Danziten, the first and only nilotinib with ...
Posted by Michael Wonder on 17 Nov 2024
Junshi Biosciences announces UK MHRA approval for marketing of toripalimab
16 November 2024 - Shanghai Junshi Biosciences announced that the UK MHRA has approved toripalimab (Loqtorzi) for the treatment of two ...
Posted by Michael Wonder on 17 Nov 2024
Evidence of clinical benefit of cancer medicines considered for funding in Australia
14 November 2024 - The objective was to describe the type of evidence and the clinical benefit of cancer medicines ...
Posted by Michael Wonder on 16 Nov 2024
Different models, same results: considerations when choosing between approaches to model cost effectiveness of chimeric antigen receptor T-cell therapy versus standard of care
7 September 2024 - Chimeric antigen-receptor T-cell therapy (CAR-T) is characterised by early phase data at the time of registration, high ...
Posted by Michael Wonder on 16 Nov 2024
Novartis Canada disappointed with outcome of pCPA negotiations for metastatic castration resistant prostate cancer treatment Pluvicto
15 November 2024 - Novartis Canada is extremely disappointed that negotiations for Pluvicto (lutetium (Lu 177 ) vipivotide tetraxetan injection), ...
Posted by Michael Wonder on 16 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for repotrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer and advanced NTRK positive solid tumours
15 November 2024 - Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity ...
Posted by Michael Wonder on 15 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer
15 October 2024 - Opinion based on results from the Phase 3 CheckMate-8HW trial, in which the dual immunotherapy combination ...
Posted by Michael Wonder on 15 Nov 2024
FDA approves revumenib for relapsed or refractory acute leukaemia with a KMT2A translocation
15 November 2024 - Today, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals), a menin inhibitor, for relapsed or refractory acute ...
Posted by Michael Wonder on 14 Nov 2024
Teclistamab for the treatment of patients with relapsed and refractory multiple myeloma after three or more treatments (final guidance)
13 November 2024 - NICE has published final evidence-based recommendations on the use of teclistamab (Tecvayli) for the treatment of ...
Posted by Michael Wonder on 13 Nov 2024
Sanofi wins appeal in spat with NICE over Sarclisa
13 November 2024 - Sanofi has taken a small step towards potentially overturning a recent rejection by NICE for NHS ...
Posted by Michael Wonder on 13 Nov 2024
Alectinib hydrochloride for the adjuvant treatment of patients with ALK positive non-small-cell lung cancer
13 November 2024 - NICE has published final evidence-based recommendations on the use of alectinib hydrochloride for the adjuvant treatment ...
Posted by Michael Wonder on 12 Nov 2024
Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
12 November 2024 - Daiichi Sankyo and AstraZeneca’s new application is based on the TROPION-Lung05 Phase 2 trial and supported ...
Posted by Michael Wonder on 11 Nov 2024
MHRA grants marketing authorisation for Balversa (erdafitinib) as monotherapy for the treatment of adults with unresectable or metastatic urothelial carcinoma (UC) harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting
6 November 2024 - Erdafitinib is the first and only bladder cancer therapy that targets FGFR3 alterations and has been ...
Posted by Michael Wonder on 09 Nov 2024
Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic test
6 November 2024 - MI Cancer Seek is the first and only simultaneous whole exome and whole transcriptome-based assay with ...
Posted by Michael Wonder on 08 Nov 2024
Dizal submits new drug application to the US FDA for sunvozertinib in treating relapsed or refractory non-small cell lung cancer with EGFR exon 20 insertion mutations
8 November 2024 - The submission is supported by data from the pivotal WU-KONG1 Part B study, which featured in an ...