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The IIT P-II (IPAX-Linz) trial assessed TLX101 (IV) in 8 glioblastoma pts with recurrent tumors & PET-confirmed amino acid uptake, who received adaptive dosing with ~4GBq before & ~2GBq after, 2L EBRT; 5/8 had MGMT-unmethylated tumors
Trial showed mOS of 12.4mos. or 32.2mos. from initial diagnosis, complementing P-I (IPAX-1) trial results of 13mos. & 23mos.,…
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Telix Pharmaceuticals’ Illuccix is approved in the UK for detecting and localizing prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET imaging.
Amidst a shortage of PET imaging agents in the UK and mainland Europe, Telix Pharmaceuticals has secured a significant advantage through an exclusive distribution partnership with Xiel Limited
Raphaël…
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The US FDA has accepted BLA & granted Priority Review to Zircaix (TLX250-CDx) for the detection of clear cell renal cell cancer (ccRCC) in pts (PDUFA: 27 Aug 2025). Expected to launch in 2025
BLA was based on P-III (ZIRCON) study assessing sensitivity & specificity of 89Zr-TLX250 in adult pts (n=300), where 284 evaluable…
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The company has reported dosing of the first patient in the US P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer
BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting
Building…
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Telix to acquire next-gen. therapeutic pipeline, biologics tech platform as well as research facility focused on protein engineering & discovery from ImaginAb via an asset purchase agreement to bolster its capabilities
As per the terms, Telix will acquire candidates incl. DLL3 & integrin αvβ6 antagonist, plus a tech platform utilizing small engineered Ab…
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BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer
37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data
Trial showed 25/37…
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Streamlining claims transactions remains a major challenge for pharmaceutical manufacturers. The financial leakage owing to non-compliant and duplicate claims costs manufacturers a fortune
Using Kalderos' Truzo platform, manufacturers can pay covered entities directly while maintaining transparency and compliance
Kate Flathers, Chief Product Officer at Kalderos, addresses the need for a compliant model for claims…
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Imaging, precision diagnostics, and targeted therapies are among the many ways radiopharmaceuticals improve patient outcomes and meet unmet healthcare needs
In 2024, the global radiopharmaceuticals market was valued at $6.74B and is envisioned to grow to $13.67B by 2033, exhibiting a CAGR of 8.2% from 2024 to 2033. Lilly ranks first in our list…
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below:
Estrella Immunopharma Reports the Approval to Start a Higher Dose Cohort After the Completion of First Dose Cohort in STARLIGHT-1 Study
Read More: Estrella Immunopharma
Regeneron Presents P-I/II (CHORD) Trial Data…
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China’s NMPA has approved NDA of tenapanor for hyperphosphatemia in CKD pts on dialysis who inadequately responded or are intolerant to phosphorus binders
Approval was based on data from 2 Fosun Pharma studies (PK study & pivotal trial in CKD pts on dialysis), plus clinical studies from Ardelyx
Approval triggered $5M milestone…

