Clinical Trial News
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.
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ModernaTX, Inc.
Posted 10/19/2023
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Zura Bio Launches Phase II TibuSHIELD Trial for Novel Dual-Inhibitor in Hidradenitis Suppurativa
• Zura Bio has initiated the Phase II TibuSHIELD trial evaluating tibulizumab, a first-of-its-kind dual inhibitor targeting both BAFF and IL-17A pathways in patients with moderate to severe hidradenitis suppurativa.
• The global, randomized, double-blind, placebo-controlled study will enroll approximately 180 patients across the US, Canada, and Europe, with topline efficacy results expected in Q3 2026.
• This trial represents Zura Bio's second Phase II study for tibulizumab, following the December launch of TibuSURE for systemic sclerosis, advancing their portfolio of treatments for severe inflammatory diseases.
FDA Grants IND Clearance for Immunoglobulin Eye Drops to Treat Dry Eye Disease
• The FDA has granted Investigational New Drug clearance for immunoglobulin eye drops (SLG-100/GRF312), developed by Selagine and Grifols, to treat dry eye disease in upcoming Phase II clinical trials.
• The novel treatment offers broad-spectrum anti-inflammatory and immunomodulatory properties, potentially providing mechanistic superiority over current narrow-spectrum therapies that primarily target T-cell inflammation.
• A first-in-human pilot trial demonstrated significant reduction in dry eye symptoms with no difference in tolerability or adverse events compared to vehicle, showing promise for the over 100 million people affected globally.
Bharat Biotech's Oral Cholera Vaccine 'Hillchol' Successfully Completes Phase III Trials
• Bharat Biotech's oral cholera vaccine Hillchol has demonstrated non-inferiority against both Ogawa and Inaba serotypes in Phase III clinical trials involving 1,800 participants across India.
• The successful trial results position Hillchol as a potential solution to the global oral cholera vaccine shortage, with Bharat Biotech's facilities capable of producing up to 200 million doses annually.
• Cholera affects approximately 2.86 million people and causes 95,000 deaths annually worldwide, highlighting the significant public health impact of this vaccine development.
Dementia Discovery Fund Secures $269M in Second Fund to Accelerate Novel Therapeutics Development
• The Dementia Discovery Fund (DDF), managed by SV Health Investors, has closed its second fund with $269 million in commitments, bringing its total raised capital to over $550 million for dementia therapeutics development.
• The fund has secured backing from previous cornerstone investors including AARP, British Business Bank, Gates Frontier, pharmaceutical giants Bristol Myers Squibb, Eli Lilly, and Pfizer, with the Alzheimer's Association joining as a new investor.
• DDF-2 has already invested in four companies and aims to build a portfolio of 10-15 innovative biotech ventures across the UK, Europe, and US, addressing the urgent global challenge of dementia affecting over 50 million people worldwide.
Juvenescence Secures $76M in Series B-1 Funding Led by Abu Dhabi's M42 for Age-Related Disease Therapeutics
• Juvenescence has raised $76 million in the first tranche of its Series B-1 financing round, led by Abu Dhabi's M42, to advance its clinical pipeline targeting age-related diseases.
• The funding is part of a strategic partnership with M42 to establish a drug development hub in Abu Dhabi, combining M42's healthcare data expertise with Juvenescence's AI-enabled discovery technology.
• Juvenescence aims to complete the full financing in Q3 2025, supporting its transition to a clinical-stage biotech company developing novel medicines that target core aging mechanisms.