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XVIVO Initiates US Continued Access Protocol Study for Heart Assist Transport Device Following Successful PRESERVE Trial

FDA Approval
  • XVIVO Perfusion has enrolled the first patient in its US PRESERVE Continued Access Protocol (CAP) study for the XVIVO Heart Assist Transport device, allowing up to 60 patients across 26 transplant centers to access the technology.
  • The FDA-approved CAP study enables continued clinical use of the heart transport device while XVIVO analyzes one-year follow-up data from the PRESERVE trial in preparation for Pre-Market Approval submission.
  • The Centers for Medicare & Medicaid Services has granted continued cost recovery approval, providing essential financial support for participating transplant centers and patients during the interim regulatory period.

Brisk Walking Shows Significant Health Benefits in Large-Scale Studies of Older Adults

  • A study of 102 older adults found that increasing walking cadence by just 14 steps per minute led to substantial improvements in physical function and frailty outcomes.
  • Research involving nearly 80,000 predominantly low-income Black Americans demonstrated that 15 minutes of daily brisk walking reduced total mortality by nearly 20%.
  • Both studies emphasize that walking pace, rather than just duration, is a critical factor in maximizing health benefits from this accessible form of exercise.
  • The findings support the development of practical interventions, including smartphone apps designed to help seniors monitor and improve their walking cadence.

CDSCO Releases New SEC Guidelines to Enhance Drug and Medical Device Approval Process

Drug Approval
  • The Central Drugs Standard Control Organisation (CDSCO) has released comprehensive Subject Expert Committees (SECs) Guidance Document Version 1.0 to streamline India's regulatory approval process for drugs and medical devices.
  • The new guidelines establish clear criteria for SEC members, requiring minimum 10 publications and 2:1 citation ratio, while mandating structured review processes with seven-day timelines for recommendations.
  • Applicants must now submit focused briefing materials limited to 20-25 slides five days before meetings, emphasizing data transparency and post-approval compliance requirements.
  • The guidelines clarify clinical trial waiver provisions for orphan drugs, pandemic treatments, and therapies approved in major regulatory jurisdictions including USA, UK, Japan, Canada, Australia, and EU.

Fangzhou and Novo Nordisk Partner to Create AI-Powered Chronic Disease Management Ecosystem in China

AI
  • Fangzhou Inc., China's leading online chronic disease management platform serving 49.2 million registered users, has signed a Memorandum of Understanding with Novo Nordisk to collaborate on managing diabetes and obesity through AI-powered solutions.
  • The partnership will leverage Novo Nordisk's expertise in diabetes and obesity treatment combined with Fangzhou's smart healthcare ecosystem to create comprehensive health management services including medication guidance, efficacy tracking, and health education.
  • The collaboration aims to shift from a "disease-centered" to a "health-centered" model, providing patients with more convenient one-stop healthcare services while supporting China's "Healthy China 2030" strategic objectives.
  • Both companies plan to explore further innovative collaborations in the medical industry's digital transformation to benefit patients with serious chronic diseases through early screening, diagnosis, and treatment implementation.

Sun Pharma's ILUMYA Achieves Primary Endpoints in Two Phase 3 Psoriatic Arthritis Trials

Monoclonal Antibody
  • Sun Pharmaceutical Industries announced that tildrakizumab (ILUMYA) 100 mg successfully met primary endpoints in two Phase 3 clinical studies for active psoriatic arthritis treatment.
  • Both INSPIRE-1 and INSPIRE-2 trials demonstrated significantly higher ACR20 response rates at week 24 compared to placebo (p < 0.05).
  • The 24-week studies showed that ILUMYA treatment resulted in greater improvements in psoriatic arthritis signs and symptoms versus placebo.
  • These positive results reinforce ILUMYA's therapeutic potential as a treatment option for patients with active psoriatic arthritis.

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

NCT04314531Active, Not RecruitingPhase 3
Sun Pharmaceutical Industries Limited
Posted 7/1/2020

Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1)

NCT04314544Active, Not RecruitingPhase 3
Sun Pharmaceutical Industries Limited
Posted 7/1/2020

AbbVie Acquires Gilgamesh's Breakthrough Depression Treatment Bretisilocin for $1.2 Billion

  • AbbVie announced a definitive agreement to acquire Gilgamesh Pharmaceuticals' bretisilocin (GM-2505) for up to $1.2 billion, marking a major investment in psychedelic-based depression treatment.
  • Phase 2a trial results showed bretisilocin achieved a -21.6-point reduction in depressive symptoms on the MADRS scale by Day 14, compared with -12.1 points for a low-dose comparator.
  • The short-acting psychedelic compound targets the serotonin 5-HT2A receptor and delivers rapid antidepressant benefits while significantly reducing the duration of hallucinogenic effects.
  • Gilgamesh will spin off a new entity retaining its employees and pipeline programs, including blixeprodil and other novel therapies for mental health disorders.

CorestemChemon Partners with ATG Lifetech to Advance Organoid-Based Preclinical Testing

Drug Discovery
  • CorestemChemon, a GLP-certified preclinical CRO from South Korea, has formed a strategic partnership with ATG Lifetech to deliver transcriptomics-powered, organoid-based preclinical testing services globally.
  • The collaboration will develop disease-relevant organoid models for liver, heart, and blood-brain barrier applications, offering up to 5x greater predictive accuracy compared to conventional 2D cell cultures.
  • The partnership aims to provide high-throughput transcriptomics analytics for tumorigenicity studies and regulatory-aligned expertise for FDA/EMA pathways across the US, Europe, and Asia.
  • Revenue-generating service offerings are expected to begin by late 2025, with joint research outputs to be showcased at a major toxicology conference in Q4 2025.

Cloudbreak Pharma's CBT-004 Achieves Primary Endpoint in Phase 2 Trial for Vascularized Pinguecula

  • Cloudbreak Pharma's CBT-004 demonstrated statistically significant improvements in conjunctival hyperemia compared to vehicle at Day 28 in a Phase 2 trial of 88 patients with vascularized pinguecula.
  • Both investigated concentrations of the preservative-free eye drop showed rapid onset of efficacy as early as Day 7 and significant improvements in five patient-reported symptoms including burning, itching, and eye discomfort.
  • The novel VEGF and PDGF receptor inhibitor exhibited an excellent safety profile with no treatment-related adverse events, positioning it as a potential first-in-class therapy for a condition affecting millions with limited treatment options.
  • The company plans to advance CBT-004 into Phase 3 development and initiate FDA discussions for regulatory approval in a market projected to reach $1.5 billion globally by 2033.

Safety and Efficacy Study of CBT-004 in Patients With Vascularized Pinguecula

NCT04884256CompletedPhase 2
Cloudbreak Therapeutics, LLC
Posted 12/21/2023

Roche's Astegolimab Shows Mixed Results in COPD Trials, Phase IIb Study Meets Primary Endpoint

Monoclonal Antibody
  • Roche's pivotal Phase IIb ALIENTO study met its primary endpoint, showing astegolimab reduced annualized exacerbation rate by 15.4% in COPD patients at 52 weeks.
  • The Phase III ARNASA study failed to meet its primary endpoint despite demonstrating a numerical 14.5% reduction in exacerbation rate.
  • Both studies enrolled broad COPD populations including former and current smokers regardless of blood eosinophil count, representing the first trials in an "all-comers" COPD population.
  • The safety profile remained consistent with previous data with no new safety signals identified across both trials.

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

NCT05595642RecruitingPhase 3
Hoffmann-La Roche
Posted 12/29/2022

A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

NCT05037929CompletedPhase 2
Genentech, Inc.
Posted 10/5/2021

Venus Remedies Receives WHO GDP Certification for Advanced Digital Logistics Operations

  • Venus Remedies secured WHO Good Distribution Practices certification for its Supply Chain Unit-II in Baddi, Himachal Pradesh, following a rigorous independent audit by SGS.
  • The company has implemented a 360-degree digital logistics model with IoT-enabled systems that monitor temperature, humidity, and location in real-time during pharmaceutical shipments.
  • Venus Remedies developed proprietary warehousing algorithms that have halved delivery times while reducing costs, demonstrating significant operational improvements in pharmaceutical distribution.
  • The certification adds to the company's portfolio of over 25 Good Manufacturing Practices certifications, reinforcing its commitment to quality across the entire pharmaceutical value chain.

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