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Alcyone Therapeutics Announces Continued Enrollment Approval from FDA of the PIERRE Pivotal IDE Clinical Study of the ThecaFlex DRx™ System for Administration of nusinersen
July 31, 2024 9:00 AM EDTAlcyone's ThecaFlex is an implantable medical device under investigation for routine subcutaneous administration of therapeutics to the cerebrospinal fluid (CSF).The first stage of the pivotal IDE PIERRE trial has been completed.10 spinal muscular atrophy (SMA) patients have undergone ThecaFlex implantation and have received nusinersen through the device.No device-related adverse events, including infections, were observed in the 30 days after implantation.FDA has agreed to an additional 80-SMA patient, 30-center, enrollment after review of the clinical data by Data Monitoring Safety Committee of first 10 SMA patients... More
New Clinical Data Demonstrates Three Years of Continuous Treatment with Dual-Acting LEQEMBI® (lecanemab-irmb) Continues to Significantly Benefit Early Alzheimer’s Disease Patients Presented at The
July 30, 2024 5:15 PM EDT51% of No Tau / Low Tau Patients Showed Improved Cognition and Function Over Three Years; Only Lecanemab Has Clinical Data in No Tau / Low Tau Patient Group
Clinical Data and Biomarkers Show Alzheimers Disease Does Not Stop Progressing After Plaque Clearance. Lecanemabs Dual Action Supports Neuronal Function by Clearing Highly Toxic Protofibrils that Continue to Cause Neuronal Injury and Death After Rapid Plaque Clearance
Lecanemab Slows Tau Spread Across All Brain Regions
PHILADELPHIA, July 30, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo,... More
