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Roche

Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Shots: Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…

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iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening

Shots: The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed…

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AstraZeneca Inks $1.9B Exclusive Licensing Deal with Sino Biopharmaceutical for TQC3721

Shots: Sino Biopharmaceutical has entered into an exclusive license agreement with AstraZeneca for the development, manufacturing & commercialization of TQC3721, an inhaled PDE3/4 inhibitor As per the deal, AstraZeneca secured exclusive rights to develop, manufacture, & commercialize TQC3721 outside China, along with exclusive global rights to select future development programs In return, Sino will receive…

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Biocytogen Collaborates with Whitehawk Therapeutics to Develop Bispecific ADC

Shots: Biocytogen has entered into a global collaboration with Whitehawk Therapeutics to develop bispecific antibody-drug conjugates (BsADCs) Biocytogen will provide ~5 bispecific antibodies from its RenLite platform & Whitehawk will evaluate these in combination with its ADC linker-payload technologies, with Whitehawk holding the option to advance resulting BsADC candidates Biocytogen will receive an upfront payment,…

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Longeviti Launches ClearFit AI Platform for Bedside Brain Ultrasound Access

Shots: Longeviti Neuro has launched ClearFit AI, a Brain Ultrasound Interface, creating a persistent acoustic window to the brain to enable real-time bedside ultrasound imaging after neurosurgery ClearFit AI combines sonolucent cranial implants, ultrasound compatibility, clinical workflow support, & AI-enhanced imaging to enable bedside brain assessment within existing neuro care workflows, potentially reducing CT/MRI transport…

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Vera Therapeutics Reports the US FDA Accelerated Approval of Trutakna (Atacicept) to Treat IgA Nephropathy

Shots: The US FDA has granted accelerated approval to Trutakna to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression Approval was supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in adults with IgAN, assessing eGFR-based kidney function over 2yrs., with…

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