Clinical Trial News
Cipla Launches ZEMDRI (Plazomicin) in India to Combat Antimicrobial Resistance
• Cipla has introduced ZEMDRI (Plazomicin), a novel intravenous aminoglycoside treatment for complicated urinary tract infections (cUTI) including pyelonephritis in adult patients in India.
• The drug demonstrates promising activity against multi-drug resistant bacteria, including Carbapenem-resistant Enterobacteriaceae (CRE), addressing a critical challenge in managing resistant infections in India.
• ZEMDRI's approval was supported by the EPIC clinical trial, the first randomized controlled study of once-daily aminoglycoside therapy for cUTI treatment, with Cipla generating India-specific pathogen data to validate its effectiveness.
New Global Report Reveals Comprehensive Landscape of Chemotherapy-Induced Diarrhea Clinical Trials
• A new comprehensive report analyzing the global clinical trial landscape for Chemotherapy-Induced Diarrhea (CID) has been released, providing crucial insights for stakeholders in pharmaceutical R&D.
• The report details trial distribution across G7 and E7 countries, enrollment trends over five years, and classifies trials by phase, status, endpoint status, and sponsor type.
• Key companies involved in CID therapeutics include Novartis AG, Jaguar Health, and Guangzhou Zhiyi Biotechnology, with the report drawing data from over 80 clinical trial registries worldwide.
Worldwide Clinical Trials Joins WCG's Avoca Quality Consortium to Enhance Clinical Trial Standards
• Worldwide Clinical Trials has joined WCG's Avoca Quality Consortium (AQC), a collaborative network of over 200 life sciences companies focused on elevating clinical trial quality.
• The strategic partnership aims to enhance quality, efficiency, and regulatory compliance through industry collaboration and best practices, ultimately delivering faster and more reliable outcomes for customers.
• This membership aligns with Worldwide's commitment to quality assurance across its services, which include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval studies.
First Patient Dosed in Phase 2 OASIS Trial of TNX-102 SL for Acute Stress Reaction Following Trauma
• Tonix Pharmaceuticals has initiated dosing in the Phase 2 OASIS trial evaluating TNX-102 SL for reducing acute stress reaction severity and acute stress disorder frequency following traumatic events.
• The investigator-initiated study, sponsored by UNC and supported by a $3 million DoD grant, will enroll approximately 180 motor vehicle collision survivors through emergency departments across the U.S.
• TNX-102 SL, a sublingual cyclobenzaprine formulation that has shown promise in improving sleep quality in PTSD patients, addresses a significant unmet need as no medications currently exist for immediate post-trauma treatment.
Related Clinical Trials:
University of North Carolina, Chapel Hill
Posted 3/25/2025
Mallia Therapeutics Advances Novel sCD83 Protein Treatment for Hair Loss
• Mallia Therapeutics has developed a topical treatment using soluble CD83 (sCD83) protein that demonstrates a dual mechanism of action for stimulating hair growth and forming new hair follicles.
• Unlike current treatments, sCD83 works locally without entering the bloodstream, potentially offering a safer alternative for both androgenetic alopecia and autoimmune-mediated alopecia areata.
• The company, co-founded by Prof. Dr. Alexander Steinkasserer who discovered sCD83 as an immune modulator, recently secured seed funding and plans to begin clinical trials within two years.
Medtronic Plans to Separate Diabetes Business into Standalone Company
• Medtronic has announced plans to separate its Diabetes business into an independent, publicly traded company within the next 18 months, enabling both entities to focus on their core strengths and growth opportunities.
• The separation is expected to improve Medtronic's financial metrics, with projected increases of approximately 50 basis points in adjusted gross margin and 100 basis points in adjusted operating margins.
• The new Diabetes Company, to be led by current EVP Que Dallara, will be positioned as the only company offering a complete ecosystem for intensive insulin management, serving patients with diabetes globally.
Faron Pharmaceuticals Appoints Ralph Hughes as Chief Business Officer to Advance Immunotherapy Pipeline
• Faron Pharmaceuticals has appointed Ralph Hughes as Chief Business Officer, bringing extensive experience in commercial strategy and market access from his previous roles at PharmaVentures, Mundipharma, and Pfizer.
• Hughes joins Faron at a critical time as the company advances its lead immunotherapy candidate bexmarilimab, currently in Phase I/II trials for acute myeloid leukemia and myelodysplastic syndrome.
• Bexmarilimab targets the Clever-1 receptor on macrophages, potentially overcoming cancer treatment resistance by reprogramming the tumor microenvironment and enhancing immune system response against cancer cells.
Triveni Bio Initiates First-in-Human Trial of TRIV-509 for Atopic Dermatitis, Targeting Novel Kallikrein Pathway
• Triveni Bio has begun dosing healthy volunteers in a Phase 1 clinical trial for TRIV-509, a dual inhibitor of kallikreins 5 and 7 (KLK5/7) designed to treat moderate-to-severe atopic dermatitis.
• Preclinical data presented at SID 2025 demonstrated TRIV-509's ability to rapidly improve skin barrier integrity, reduce epidermal thickness, and increase desmoglein-1 expression in atopic dermatitis patient explants.
• The company is also advancing TRIV-573, a next-generation bispecific antibody targeting both KLK5/7 and IL-13, currently in IND-enabling studies, expanding their novel approach to inflammatory skin disorders.
ME Therapeutics Secures $140,000 in Funding to Advance Novel mRNA Cancer Therapies
• ME Therapeutics has received up to $140,000 in funding from Canada's NRC IRAP to advance its mRNA therapeutic program targeting myeloid cell biology for cancer and inflammatory diseases.
• The company's proprietary mRNA sequences are engineered to encode proteins that modify immune responses, with preclinical testing showing promising anti-cancer activity in colorectal cancer mouse models.
• ME Therapeutics is developing tissue-specific mRNA expression modifications to enhance efficacy and safety, potentially offering new treatment options for patients with limited alternatives.
Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year
• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.
• The company plans to resubmit the application later in 2025 after obtaining vaccine efficacy data from an ongoing Phase 3 trial of its seasonal influenza vaccine candidate, mRNA-1010.
• Interim data from the mRNA-1010 Phase 3 trial is expected to be available this summer, which will inform the resubmission strategy for the combination vaccine.
Related Clinical Trials:
ModernaTX, Inc.
Posted 10/19/2023
ModernaTX, Inc.
Posted 9/16/2024