Clinical Trial News
Kakao Healthcare Expands AI-Powered Glucose Monitoring App to Japanese Market
• Kakao Healthcare Corp. is launching its AI-powered continuous glucose monitoring app PASTA in Japan through a new subsidiary, marking a significant step in the company's global expansion strategy.
• PASTA integrates with CGM sensors from I-sens Inc.'s Caresens Air and Dexcom Inc.'s G7 system, providing advanced diabetes management capabilities through artificial intelligence technology.
• The expansion follows Kakao's recent initiatives in data-driven healthcare, including plans to develop an "AI-platform bridge" connecting medical institutions, government, and industry for drug discovery and research.
BGG Expands World's Largest Astaxanthin Facility in China, Doubles R&D Capacity
• BGG is expanding its astaxanthin manufacturing facilities in China's Yunnan Province, consolidating the entire production chain within a 20km area to improve efficiency and reduce carbon footprint.
• The company is opening a new research laboratory and more than doubling its R&D team, focusing on microalgae innovation and collaborating with research institutes on tropical plants and fungi.
• This expansion follows previous growth in 2023-2024 that doubled production capacity, reinforcing BGG's position as the world's largest producer of natural astaxanthin from Haematococcus pluvialis microalgae.
Trump's "Most Favored Nation" Drug Pricing Policy Threatens German Pharma Industry
• President Trump's executive order implementing a "Most Favored Nation" pricing policy could slash U.S. drug prices by 30-80%, sending shockwaves through the global pharmaceutical industry.
• German pharmaceutical giants like Merck and Bayer face significant threats, with Simon-Kucher consultancy projecting potential 64% drops in U.S. pharmaceutical sales and 37% global declines.
• A Deloitte study warns that a 35% U.S. tariff on drug imports could reduce German pharmaceutical exports to the U.S. by 53%, potentially causing industry losses of up to €13.4 billion over 3-4 years.
Tessera Therapeutics Reports Breakthrough Gene Editing Results for Multiple Genetic Diseases
• Tessera's RNA Gene Writer technology achieved 76% and 70% editing efficiency in hepatocytes for alpha-1 antitrypsin deficiency and phenylketonuria respectively, with high specificity and durability in non-human primate studies.
• Preclinical data for sickle cell disease demonstrated greater than 20% editing in long-term hematopoietic stem cells across multiple species, potentially reaching curative thresholds without requiring stem cell transplantation.
• The company's proprietary lipid nanoparticle delivery system showed high liver specificity with no off-target activity detected, advancing the potential for in vivo gene editing therapies for multiple genetic disorders.
Pharmaceutical-Grade Cannabidiol Shows Promising Cardiac Safety Profile in High-Risk Patients
• A pharmaceutically manufactured cannabidiol formulation demonstrated a favorable cardiac safety profile in patients with cardiovascular risk factors, according to research presented at Heart Failure 2025.
• The placebo-controlled trial involving 89 patients showed comparable adverse event rates between GMP-cannabidiol (24.4%) and placebo (22.7%), with no significant differences in cardiac disorders reported in both groups (9%).
• These safety findings support ongoing investigations of cannabidiol for inflammatory heart conditions, with results from the ARCHER trial in acute myocarditis expected later in 2025 and the MAVERIC trial in recurrent pericarditis in 2026.
Highlighted Clinical Trials:
Cardiol Therapeutics Inc.
Posted 6/22/2022
Cardiol Therapeutics Inc.
Posted 4/7/2025
Thermo Fisher Scientific Launches Cell and Gene Therapy Vision Centre in South Korea to Accelerate Advanced Therapeutic Development
• Thermo Fisher Scientific has opened a new Cell and Gene Therapy Vision Centre in South Korea, designed to support biopharmaceutical companies throughout the therapy development pipeline from discovery to commercialization.
• The state-of-the-art facility will provide access to cutting-edge technologies, regulatory expertise, and end-to-end workflow solutions, serving as a regional hub for hands-on training and process optimization.
• South Korea's cell and gene therapy market is projected to grow at a CAGR of 16.9% from $0.489 billion in 2023 to $1.067 billion by 2027, highlighting the strategic importance of this investment.
EL1SSAR Trial Confirms Efficacy of Atezolizumab Plus Nab-Paclitaxel in PD-L1-Positive Advanced TNBC
• The phase IIIb EL1SSAR trial demonstrates that atezolizumab plus nab-paclitaxel provides significant clinical benefit in PD-L1-positive advanced triple-negative breast cancer, with median overall survival reaching 27 months in the overall population.
• Patients with centrally confirmed PD-L1-positive tumors showed superior outcomes, with median progression-free survival of 11.1 months and overall survival not yet reached, highlighting the importance of accurate biomarker testing.
• The safety profile was consistent with previous findings from the IMpassion130 trial, with 47% of patients experiencing grade ≥3 adverse events and 12% developing grade ≥2 immune-mediated adverse events, with no treatment-related deaths reported.
Highlighted Clinical Trials:
Hoffmann-La Roche
Posted 12/17/2019
Fractyl Health's Novel Smart GLP-1 Gene Therapy Shows Promise for Diabetes and Obesity Treatment
• Fractyl Health's RJVA-001, a single-dose pancreatic gene therapy, demonstrated durable metabolic improvements in diabetic mouse models with significantly lower systemic GLP-1 exposure than conventional GLP-1 drugs.
• The therapy mimics natural hormone regulation through nutrient-responsive GLP-1 secretion from pancreatic beta cells, potentially addressing durability, adherence, and tolerability challenges seen with current GLP-1 medications.
• Endoscopic ultrasound-guided delivery achieved targeted pancreatic expression with no observed toxicity in large animal models, positioning RJVA-001 for first-in-human studies with CTA submission expected by June 2025.
Eisai's Remitoro Clears Post-Marketing Surveillance Requirements for T-Cell Lymphoma Treatment in Japan
• Japan's Ministry of Health has lifted the all-case surveillance requirement for Eisai's anticancer agent Remitoro after reviewing safety data from 111 patients and efficacy data from 85 patients with T-cell lymphoma.
• Remitoro, a fusion protein combining IL-2 and diphtheria toxin, demonstrated an overall response rate of 16.5% across both peripheral and cutaneous T-cell lymphoma patients in the post-marketing study.
• Common adverse reactions included elevated liver enzymes (22.5%), capillary leak syndrome (21.6%), and decreased platelet count (15.3%), confirming the safety profile in real-world clinical settings.
AI in Oncology: Transforming Community Practice from Patient Care to Revenue Cycles
• AI adoption in oncology practices is rapidly growing, with current utilization at 40-50% and projected to reach 70-80% in the next few years, enhancing both clinical decision support and practice operations.
• AI technologies are improving patient care by facilitating education, reducing financial toxicity, streamlining practice connections, and helping clinicians manage the increasing complexity of precision medicine data.
• Community oncology practices need a pragmatic, strategic approach to AI implementation that prioritizes specific practice needs, workflow integration, and patient readiness to maximize benefits while addressing potential disparities.