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Roche Secures Second CE Mark for Eli Lilly-Co-Developed Alzheimer's Blood Test pTau217 in Europe

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Roche's Elecsys pTau217 blood test, co-developed with Eli Lilly, received CE-mark approval in Europe on May 12, 2026. This is the second Alzheimer's blood test approved in Europe, following the earlier pTau181 test. pTau217 offers both rule-in and rule-out capabilities for Alzheimer's, unlike pTau181 which mainly rules out amyloid pathology. Validated for use in both primary and specialist care settings. Expected availability in CE-marked European markets starting July 2026. Has breakthrough device designation from the U.S. FDA. Sources:

FDA Commissioner Marty Makary to Resign, Capping Turbulent Tenure: Report

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MRD as a Decision Engine: Rethinking Oncology Trial Design from Early Phase to Registration

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GSK acquires Siran Biotechnology for $1 billion to expand beyond weight-loss with siRNA therapy

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FDA Publishes Complete Response Letters Revealing Manufacturing and Data Gaps as Primary Reasons for Drug Rejections

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Daiichi Sankyo Targets Nearly $15B in Oncology Sales by 2030 via ADC Franchise Expansion

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FibroBiologics Advances Fibroblast Platform for Hantavirus Pulmonary Syndrome Treatment

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CSL Takes $5B Impairment Charge and Revenue Cut

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Inhibrx's OX40 Agonist INBRX-106 Doubles Tumor Response Rate with Keytruda in Head and Neck Cancer Trial

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Argenx's Vyvgart and Vyvgart Hytrulo Receive FDA Label Expansion for All Adult gMG Patients

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Astellas Highlights Positive Early Data from Stem Cell-Derived RPE Therapy for Geographic Atrophy

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Capricor Sues Nippon Shinyaku and NS Pharma Over Pricing Flaw and Launch Delays for Deramiocel DMD Therapy

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Trump Reportedly Planning to Fire FDA Commissioner Marty Makary

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