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Foresight Diagnostic & Allogene Therapeutics
Foresight Diagnostic & Allogene Therapeutics Extend Collaboration to Develop Minimal Residual Disease (MRD) Assay
Shots: Foresight & Allogene have expanded their strategic collaboration to develop minimal residual disease (MRD) assay as companion diagnostic to identify candidates for Allogene's ALPHA3 trial assessing cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL) pts As per the collaboration, Allogene & Foresight will develop Foresight's MRD assay in the EU, UK, Canada &…
February 28, 2025
GRIN Therapeutic
GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder
Shots: The US FDA has granted BTD to radiprodil for the treatment of seizures in GRIN-related neurodevelopmental disorder harboring GoF mutations Designation was supported by P-Ib (Honeycomb) trial data of radiprodil in pediatric pts, showing 86% decrease in CMS frequency. 71% had >50% CMS reduction, & 6–7 were seizure-free for ≥80% of the 8wk.…
February 27, 2025
Belite Bio
Belite Bio Reveals Interim P-III (DRAGON) Trial Data of Tinlarebant for Adolescent Stargardt Disease
Shots: Belite Bio has reported 1yr. interim data from P-III (DRAGON) trial assessing tinlarebant vs PBO in adolescent stargardt disease pts (n=104). Completion expected in Q4’25 with DSMB recommending data submission for regulatory review The global Phase III trial utilized an adaptive sample size re-estimation design to evaluate atrophic lesion growth rate, safety & tolerability…
February 27, 2025
VeroSource
VeroSource Solutions Launches Digital Twin on its VS Platform
Shots: VeroSource (HEALWELL AI’s subsidiary) has launched a Digital Twin on its VS Data-as-a-Service Platform to analyse & predict healthcare facility operations Digital Twin integrates HL7 & ERP data into the VS Platform & creates a real-time virtual replica of healthcare facilities, allowing managers to make data-driven decisions on capacity, staffing, & expansion for daily &…
February 27, 2025
Bayar
Bayer Presents P-III (QUANTI CNS) Trial Data of Gadoquatrane at European Congress of Radiology 2025
Shots: The P-III (QUANTI CNS) trial assessed GBCA gadoquatrane (0.04mmol Gd/kg) vs macrocyclic GBCAs (0.1mmol Gd/kg) in adults (n=305) with confirmed or suspected CNS pathologies undergoing contrast-enhanced MRI Study showed non-inferiority (1EP) & superiority across all visualization criteria (contrast enhancement, delineation, & morphology), plus higher sensitivity & specificity (2EP) for lesion detection & exclusion…
February 27, 2025
Astrazeneca
AstraZeneca Reports Interim Data from P-III (SERENA-6) Trial of Camizestrant to Treat Advanced Breast Cancer
Shots: The P-III (SERENA-6) trial assessed camizestrant + CDK4/6 inhibitor (palbociclib/ribociclib/abemaciclib) vs AI (anastrozole/letrozole) + CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- breast cancer harboring ESR1 mutation SERENA-6 used ctDNA-guided approach to monitor ESR1 mutations at routine scans for the early detection of endocrine resistance, allowing pts to switch to camizestrant before disease…
February 26, 2025
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