Lecanemab Shows Long-Term Benefits in Early Alzheimer's, Eisai Presents New Data
Lecanemab demonstrates sustained cognitive and functional benefits over three years in patients with early Alzheimer's disease, particularly those with low amyloid or tau levels.
Baili Tianheng's BL-B01D1 Shows Promise in Multiple Phase III Trials
Baili Tianheng reported a significant increase in operating income, driven by an upfront payment from BMS for their BL-B01D1 collaboration.
HighField Biopharma's HF50 T-Cell Engager Cleared for Solid Tumor Trial in China
HighField Biopharmaceuticals received IND clearance from China's NMPA for HF50, a novel T-cell engager, to treat advanced solid tumors.
Trastuzumab Deruxtecan Improves PFS in HER2-Low/Ultralow Metastatic Breast Cancer Regardless of Endocrine Resistance
Trastuzumab deruxtecan (T-DXd) significantly improved progression-free survival (PFS) compared to physician's choice of chemotherapy (TPC) in HR-positive, HER2-low/ultralow metastatic breast cancer patients.
Reviva's Brilaroxazine Shows Sustained Efficacy and Safety in Schizophrenia Patients Over One Year
Reviva Pharmaceuticals' brilaroxazine demonstrated sustained efficacy and a favorable safety profile over one year in patients with schizophrenia in the Phase 3 RECOVER study's open-label extension (OLE).
IDEAYA's Darovasertib and Crizotinib Combination Advances in Uveal Melanoma Trial
IDEAYA Biosciences' combination therapy of darovasertib and crizotinib receives IDMC recommendation to advance to Part 2b of Phase 2/3 trial.
Sotagliflozin Demonstrates Renal Protective Benefits in Diabetic Kidney Disease: Phase 3 Data
A new analysis of the Phase 3 SCORED trial reveals that sotagliflozin provides renal protection in patients with diabetic kidney disease (DKD).
FDA Expands Dostarlimab Approval for Advanced Endometrial Cancer Based on RUBY Trial
The FDA expanded the approval of dostarlimab plus chemotherapy for primary advanced or recurrent endometrial cancer on August 1, 2024.
UGN-102 Shows Durable Response in Low-Grade Bladder Cancer Trial
The ENVISION trial results, published in the _Journal of Urology_, demonstrate an 82.3% duration of response at 12 months in patients treated with UGN-102 who achieved complete response.
Rallybio's RLYB212 Phase 2 Trial for FNAIT Prevention Approved in Europe
Rallybio has received approval from the EMA and MHRA for a Phase 2 trial of RLYB212 in pregnant women at high risk of HPA-1a alloimmunization and FNAIT.
Rallybio's RLYB212 Phase 2 Trial for FNAIT Prevention Approved in Europe
Rallybio has received approval from the EMA and MHRA for its Phase 2 clinical trial application of RLYB212 in pregnant women at high risk for FNAIT.
Rallybio's RLYB212 Phase 2 Trial for FNAIT Prevention Approved in Europe
Rallybio has received approval for its Phase 2 clinical trial application for RLYB212, targeting pregnant women at higher risk of alloimmunization and FNAIT.
EMA Postpones Decision on Sputnik V Vaccine Approval Until September
The European Medicines Agency (EMA) has delayed its decision on approving the Russian Sputnik V vaccine, with a decision expected no earlier than September due to missing data.
Exenatide Fails to Reduce Complications in Heart Surgery Patients: GLORIOUS Trial
A large clinical trial (GLORIOUS) found that intravenous exenatide during heart surgeries with bypass did not significantly reduce the risk of death, stroke, or organ failure.
Inventiva's Lanifibranor Maintains Positive Safety Profile in Phase 3 MASH Trial
The Data Monitoring Committee (DMC) recommended the continuation of Inventiva's Phase 3 NATiV3 trial for MASH without protocol modification.
Puma Biotechnology Initiates Phase II Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer
Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib combined with endocrine therapy for HR+/HER2- metastatic breast cancer.
Puma Biotechnology Initiates Phase II Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer
Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib combined with endocrine therapy for HR+/HER2- metastatic breast cancer.
Puma Biotechnology Initiates Phase II Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer
Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib combined with endocrine therapy for HR+/HER2- metastatic breast cancer.
Radiomics and Morphomics Predict Colorectal Cancer Recurrence Risk
Radiomic features from tumor imaging and morphomic features of body composition independently correlate with colorectal cancer (CRC) recurrence risk.
Lexicon's LX9211 Phase 2b Trial for Diabetic Neuropathic Pain Completes Screening Ahead of Schedule
Lexicon Pharmaceuticals has completed screening for its Phase 2b PROGRESS study of LX9211 in patients with Diabetic Peripheral Neuropathic Pain (DPNP).