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Foresight Diagnostic & Allogene Therapeutics
NEWS

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

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New Drug Designations - January 2025
INSIGHTS+

New Drug Designations – January 2025

Shots:    PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA  The January 2025 report covers designations granted to 53 drugs and 9 medical devices, spanning 18 small molecules, 13 biologics, 13 cell and gene therapies & 9 medical devices among…
February 28, 2025

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GRIN Therapeutic
NEWS

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

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Belite Bio
NEWS

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

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Bayar
NEWS

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

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ABANZA
NEWS

ABANZA Reports the US FDA 510(k) Clearance of WasherCap Mini for Orthopedic Surgeries

Shots: The US FDA has granted 510(k) clearance to WasherCap Mini (knotless suture & tape fixation) system, allowing bidirectional tension control in various procedures incl. meniscal root repair & ACL reconstruction WasherCap Mini has provided superior fixation strength & reduced displacement during cyclic loading compared to traditional devices in biomechanical testing, independent of the…
February 27, 2025

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Astrazeneca
NEWS

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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Telix Pharmaceuticals
NEWS

Telix Pharmaceuticals Reports the US FDA’s BLA Acceptance with Priority Review of Zircaix (89Zr-DFO-girentuximab) for Kidney Cancer Imaging

Shots: 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…
February 26, 2025

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