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Clinical Trial News

Japan Approves Eli Lilly's Donanemab for Alzheimer's Disease

  • Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for Eli Lilly's donanemab, marking a significant advancement in Alzheimer's treatment.
  • Donanemab is a monoclonal antibody designed to target and remove amyloid plaques, a key pathological hallmark of Alzheimer's disease, from the brain.
  • This approval offers a new therapeutic option for patients in Japan, addressing a critical unmet need in managing the progression of Alzheimer's.
  • The decision is based on clinical trial data demonstrating donanemab's efficacy in slowing cognitive decline in early-stage Alzheimer's patients.

NIHR Transitions to Research Delivery Network to Enhance Clinical Trial Support

  • The National Institute for Health and Care Research (NIHR) is transitioning to the Research Delivery Network (RDN) in April 2024 to bolster research support.
  • The RDN will operate as a unified organization across England, ensuring consistent service and promoting innovation in research delivery.
  • A key focus of the RDN will be expanding commercial clinical research, aligning with government strategies to reestablish the UK as a leader in this field.
  • The RDN aims to enhance research capacity, involve more participants, and extend research benefits to underserved regions with significant health needs.

Lipidor AB Initiates Phase III Trial of AKP02G2 for Psoriasis Treatment

  • Lipidor AB has enrolled the first patient in its Phase III clinical trial evaluating AKP02G2, a topical spray for mild to moderate psoriasis.
  • AKP02G2 combines calcipotriol and betamethasone, utilizing Lipidor's AKVANO technology, aiming for efficacy comparable to Enstilar.
  • The Phase III study, managed by Cliantha, plans to enroll 294 patients to assess AKP02G2's effectiveness and patient-friendliness.
  • AKP02G2 seeks to provide a fast-drying, easy-to-use treatment option for psoriasis patients, potentially improving adherence and outcomes.

Hesperos' Human-on-a-Chip Technology Supports Phase II Trial of DNTH103 for Generalized Myasthenia Gravis

  • Hesperos' Human-on-a-Chip technology supported Dianthus Therapeutics' Investigational New Drug submission for DNTH103, a monoclonal antibody, to the FDA.
  • DNTH103 is currently in a Phase II clinical trial for the treatment of generalized myasthenia gravis (gMG), a chronic autoimmune disorder.
  • Preclinical data using Hesperos' neuromuscular junction model demonstrated DNTH103 improved nerve cell transmission and decreased muscle fatigue in gMG patient serum.
  • The Human-on-a-Chip platform offers physiologically relevant functional readouts, potentially predicting therapeutic profiles and accelerating drug development.

A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)

NCT06282159Active, Not RecruitingPhase 2
Dianthus Therapeutics
Posted 2/23/2024

HOMER Study Adapts to Pandemic, Advances Opioid Use Disorder Treatment Research

  • The HOMER study, designed to compare buprenorphine induction methods for opioid use disorder (OUD), faced significant challenges due to the COVID-19 pandemic.
  • To address these challenges, the study design was adapted to include telehealth inductions and transitioned to a comprehensive cohort design accommodating patient preferences.
  • The study also addressed the evolving landscape of OUD treatment, including the use of low-dose buprenorphine and the rise of mixed drug use.
  • Despite obstacles, the HOMER study enrolled nearly 300 participants, providing valuable insights into OUD treatment in primary care settings.

Comparing Home, Office, and Telehealth Induction for Medication Assisted Treatment for Opioid Use Disorder

NCT04664062Active, Not RecruitingNot Applicable
University of Colorado, Denver
Posted 5/13/2021

PARTIQoL Trial Assesses Proton Therapy vs. IMRT for Localized Prostate Cancer

  • The PARTIQoL trial is a randomized phase III study comparing proton beam therapy to IMRT for localized prostate cancer, focusing on patient-reported outcomes.
  • The trial enrolled 450 patients across 29 centers, employing strategies to overcome accrual challenges, including patient-centric initiatives and insurance partnerships.
  • Preliminary data suggests that proton therapy may offer dosimetric advantages, potentially reducing side effects and second cancer risk, but rigorous data is still needed.
  • The study's primary endpoint is patient-reported bowel function at 24 months, with longer follow-up ongoing to assess the long-term impact on quality of life.

ZKR Orthopedics Initiates FDA Trial for Patella LIFT Procedure in Patellofemoral Arthritis

  • ZKR Orthopedics has commenced its FDA PELICAN trial with the first U.S. patella LIFT procedure for patellofemoral arthritis.
  • The minimally invasive Patella LIFT aims to alleviate pain by unloading the patella, offering a less complex alternative to traditional surgeries.
  • The PELICAN study will compare the Patella LIFT Implant to tibial tubercle osteotomy, assessing patient-reported outcomes and safety.
  • The trial, involving multiple sites in the U.S. and Europe, follows promising results from a European pilot study showing improved function.

B. Braun's Introcan Safety 2 Deep Access IV Catheter Receives FDA Clearance

  • B. Braun Medical's Introcan Safety 2 Deep Access IV Catheter has received FDA 510(k) clearance, expanding the Introcan Safety 2 portfolio.
  • The catheter combines features of the original Introcan Safety 2 Multi-Access and Deep Access catheters for enhanced vascular access.
  • Designed for deeper veins and longer dwell times, it aims to reduce PIVC restarts and the need for more invasive procedures.
  • The catheter includes passive safety needlestick protection and multi-access blood control to minimize blood exposure during IV therapy.

RPLND Shows Promise in Early-Stage Seminoma, Reducing Need for Chemo

  • Retroperitoneal lymph node dissection (RPLND) is emerging as an effective treatment for early-stage II seminoma, potentially reducing reliance on chemotherapy.
  • Studies show RPLND yields 2-year recurrence-free survival rates of 70-90% without adjuvant therapy, influencing updated AUA and NCCN guidelines.
  • Most recurrences post-RPLND occur within two years, emphasizing the need for vigilant surveillance and the effectiveness of salvage chemotherapy.
  • Refinements in RPLND techniques have led to fewer complications and shorter hospital stays, enhancing its viability as a primary treatment option.

Retroperitoneal Lymph Node Dissection in Treating Patients With Testicular Seminoma

NCT02537548Active, Not RecruitingNot Applicable
University of Southern California
Posted 8/28/2015

Trial to Evaluate Progression Free Survival With Primary Retroperitoneal Lymph-node Dissection (pRPLND) Only in Patients With Seminomatous Testicular Germ Cell Tumors With Clinical Stage IIA/B (PRIMETEST)

NCT02797626Unknown StatusPhase 2
Heinrich-Heine University, Duesseldorf
Posted 6/1/2016

Critical Review Questions Vorasidenib's Role in Low-Grade Glioma Treatment

  • A critical evaluation of vorasidenib, a new drug for IDH-mutant low-grade gliomas (LGGs), raises concerns about its approval process and actual benefits for patients.
  • The review highlights that the INDIGO trial compared vorasidenib against a placebo instead of the current standard treatment, chemoradiotherapy, raising ethical questions.
  • The analysis points out the absence of evidence indicating that vorasidenib improves overall survival or quality of life compared to existing therapies, despite its high cost.
  • Experts suggest conducting more rigorous trials directly comparing vorasidenib with standard treatments to reassess its efficacy and cost-effectiveness in treating LGGs.

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