Skip to content Skip to footer

NEWS

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 &…
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.…
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…
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 &…
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…
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…
Solventum
Thermo Fisher Scientific to Acquire Solventum’s Purification & Filtration Business for ~$4.1B
Shots: Thermo Fisher has entered into definitive agreement with Solventum to acquire its purification & filtration business for ~$4.1B in cash, adding value to its upstream and downstream biologics development & manufacturing Transaction is expected to close by the end of 2025, pending regulatory approval & customary closing conditions Solventum's purification and filtration unit…