Clinical Trial News Archive - December 2023
December 1, 2023
December 4, 2023
- Genentech Announces Positive Phase III Results for Inavolisib Combination in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
- Genentech Announces Positive Phase III Results for Inavolisib Combination in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
- Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer
- Viracta Therapeutics Announces Interim Data from Phase 1b/2 Clinical Trial of Nana-val in Patients with Epstein-Barr Virus-Positive Solid Tumors that Show Confirmed Tumor Responses at Higher Dose Levels
- Everest Medicines Announces Investigational New Drug Application Acceptance of Zetomipzomib in China
December 5, 2023
- Replimune Shares Initial Primary Analysis Results from CERPASS Clinical Trial in Advanced Cutaneous Squamous Cell Carcinoma and Presents New Data from IGNYTE Clinical Trial of RP1 in Anti-PD1 Failed Melanoma and Non-Melanoma Skin Cancers
- Trevi Therapeutics Announces the Initiation of its Phase 2b CORAL Clinical Trial of Haduvio for Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)
- Ascletis Announces Initiation of Phase III Clinical Trial of ASC40 (Denifanstat) for Treatment of Acne
- NeuroSense's Phase 2b ALS Trial Achieves Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints
December 6, 2023
- Coherus Presents Phase 1/2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody
- Dragonfly Therapeutics Initiates Phase 1/1b Study of its IL-2 Immunotherapy in Patients with Advanced Solid Tumors
December 7, 2023
- Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine
- Updated Linvoseltamab Pivotal Data Demonstrated Strong Rates and Depth of Response in Patients with Heavily Pre-Treated Multiple Myeloma
- Vesper Bio doses first volunteer in Phase I study of first-in-class oral treatment for Frontotemporal Dementia
- NIH Clinical Trial of Tuberculous Meningitis Drug Regimen Begins
- Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)
December 8, 2023
December 9, 2023
December 10, 2023
- New Hybrid Treatment Forces Cancer Cells to Starve
- Latest Odronextamab Data in Relapsed/Refractory Follicular Lymphoma Showed Compelling Responses and Overall Maintenance of Patient-Reported Outcomes
- Updated Odronextamab Data from Relapsed/Refractory Diffuse Large B-cell Lymphoma Pivotal Trial Showed Deep and Durable Responses and the Potential of ctDNA To Predict Long-term Outcomes
- Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease
December 11, 2023
- Syndax Announces Positive Data for Revumenib in Patients with Acute Leukemias from the BEAT AML, SAVE AML and AUGMENT-102 Phase 1 Combination Trials
- Erasca Granted FDA Fast Track Designation for Pan-RAF Inhibitor Naporafenib in Patients with Advanced NRAS-Mutated Melanoma
- Two Early Studies Evaluating Potential First-in-Class CELMoD™ Agent Golcadomide for the Treatment of Non-Hodgkin Lymphomas Presented at ASH 2023
- Merck and Moderna Initiate INTerpath-002, a Phase 3 Study Evaluating V940 (mRNA-4157) in Combination with Keytruda® (pembrolizumab) for Adjuvant Treatment of Patients with Certain Types of Resected Non-Small Cell Lung Cancer
December 12, 2023
- Candel Therapeutics Receives FDA Fast Track Designation for CAN-2409 in Pancreatic Cancer
- Viracta Therapeutics Announces Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the Treatment of Nasopharyngeal Carcinoma
- Zepbound achieved additional 6.7% weight loss following a 36-week open-label lead-in period, for a total mean weight loss of 26.0% from study entry over 88 weeks
December 13, 2023
December 14, 2023
- MindMed Announces Positive Topline Results from Phase 2b Trial of MM-120 in Generalized Anxiety Disorder
- Moderna and Merck Announce mRNA-4157 (V940) in Combination with Keytruda® (pembrolizumab) Demonstrated Continued Improvement in Recurrence-Free Survival and Distant Metastasis-Free Survival in Patients with High-Risk Stage III/IV Melanoma Following Complete Resection Versus KEYTRUDA At Three Years
- NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial
- Acesion Pharma announces Nature Medicine publication of clinical results in Atrial Fibrillation
- NIH Research Identifies Opportunities to Improve Future HIV Vaccine Candidates
December 15, 2023
December 16, 2023
December 18, 2023
- Invivyd Announces Positive Initial Results from Ongoing CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of COVID-19
- Azura Ophthalmics Announces Positive Results from Phase 2 Clinical Trial of AZR-MD-001 in Patients with Contact Lens Discomfort
- Crinetics Announces Positive Initial Findings from Ongoing Open-Label Phase 2 Study of Paltusotine for the Treatment of Carcinoid Syndrome
- Two Phase 3 Trials of Datopotamab Deruxtecan Plus Durvalumab Initiated in Patients Across Two Breast Cancer Subtypes
December 19, 2023
- FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults
- Antibody Reduces Allergic Reactions to Multiple Foods in NIH Trial
December 20, 2023
- ChemDiv Helps Advance Viriom's Influenza Treatment to Successful Phase I Clinical Trials Completion
- Marburg vaccine tested at Texas Biomed moves to Phase 2 clinical trials
- Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia
- Shorla Oncology and Eversana Announce U.S. Launch of Jylamvo
December 21, 2023
December 22, 2023
- Cellusion Receives U.S. FDA Orphan Drug Designation for CLS001
- First patient dosed in Phase III prostate cancer trial with Cu-64 SAR-bisPSMA
December 27, 2023
December 28, 2023
December 30, 2023
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