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Clinical Trial News

Lupkynis (Voclosporin) Approved in Japan for Lupus Nephritis Treatment

  • The Japanese Ministry of Health, Labour, and Welfare approved Lupkynis (voclosporin) in combination with mycophenolate mofetil for treating lupus nephritis.
  • This approval was based on the AURORA Clinical Program, which demonstrated Lupkynis' efficacy and safety in treating lupus nephritis patients.
  • Aurinia Pharmaceuticals is eligible to receive a $10 million payment from Otsuka Pharmaceutical, along with royalties on net sales, following the approval.
  • Lupkynis, a second-generation calcineurin inhibitor, is now approved in Japan, the U.S., the U.K., the European Union, and Switzerland for lupus nephritis.

Aurinia Renal Response in Active Lupus With Voclosporin

NCT03021499CompletedPhase 3
Aurinia Pharmaceuticals Inc.
Posted 5/17/2017

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

NCT03597464CompletedPhase 3
Aurinia Pharmaceuticals Inc.
Posted 9/29/2019

Senseonics' Eversense 365 CGM System Receives FDA Clearance for One-Year Use

  • Senseonics and Ascensia Diabetes Care secured FDA clearance for Eversense 365, a next-generation continuous glucose monitoring (CGM) system, for adults with type 1 and type 2 diabetes.
  • Eversense 365 is the first iCGM system that can integrate with compatible medical devices, including insulin pumps, as part of an automated insulin delivery system.
  • The Eversense 365 system offers continuous glucose monitoring for up to one year with a single sensor, reducing the frequency of sensor replacements compared to short-term CGMs.
  • Ascensia plans to launch Eversense 365 in the U.S. in the fourth quarter of 2024, aiming to facilitate broad access for users.

Transgene's Immunotherapy Pipeline Advances with Key Data Readouts Expected in Q4 2024

  • Transgene's TG4050, an individualized immunotherapy for head and neck cancer, shows promising Phase I data with a 24-month follow-up to be presented in Q4 2024.
  • BT-001, an oncolytic virus, demonstrates encouraging antitumor activity in solid tumors resistant to previous anti-PD(L)-1 treatments, as presented at ESMO 2024.
  • Topline results from the Phase II trial of TG4001, a therapeutic cancer vaccine for HPV-positive anogenital cancers, are anticipated in Q4 2024.
  • Initial Phase I data for TG6050, a novel intravenously administered oncolytic virus for advanced non-small cell lung cancer, are expected in Q4 2024.

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

NCT04183166Active, Not RecruitingPhase 1
Transgene
Posted 12/12/2019

A Clinical Trial of TG6050 in Patients With Metastatic Non-Small Cell Lung Cancer (Delivir)

NCT05788926TerminatedPhase 1
Transgene
Posted 4/5/2023

Phase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers

NCT03260023Active, Not RecruitingPhase 1
Transgene
Posted 9/11/2017

Magnesium Sulfate Prevents Cerebral Palsy in Premature Babies: Cochrane Review

  • A Cochrane review confirms that magnesium sulfate infusions given to women at risk of premature birth can prevent cerebral palsy in their babies.
  • The inexpensive treatment, costing approximately $6.50 per dose, has been recommended by the WHO since 2015 for women at risk of premature birth before 32 weeks.
  • A program in England demonstrated that widespread use of magnesium sulfate resulted in an estimated 385 fewer cases of cerebral palsy between 2018 and 2023.
  • Researchers call for increased global implementation and further studies to optimize the drug's administration, especially in low-resource settings.

Robust Clinical Trial Pipeline Fuels Hope for Renal and Breast Cancer Advances

• The renal cancer clinical trial pipeline is robust, with over 70 companies developing more than 75 therapies, including novel immunotherapies and targeted agents. • Breast cancer research is also thriving, with over 100 companies exploring 120+ new drugs, such as antibody-drug conjugates and PARP inhibitors, in clinical trials. • Recent FDA actions, including Fast Track and Breakthrough Therapy designations, highlight the potential of emerging therapies for both renal and breast cancer. • Advances in diagnostics, such as PET imaging agents for clear cell renal cell carcinoma, are also contributing to improved management of these diseases.

FDA Accepts Roflumilast Foam sNDA for Scalp and Body Psoriasis Treatment

• The FDA has accepted Arcutis Biotherapeutics' sNDA for roflumilast foam 0.3% (Zoryve) for treating scalp and body psoriasis in patients aged 12 and older. • The acceptance is based on positive results from the ARRECTOR phase 3 trial, a phase 2b study, and long-term data from the Zoryve cream development program. • Roflumilast foam demonstrated significant improvements in reducing scalp and body itch compared to the vehicle in clinical studies. • The FDA has set a PDUFA target action date of May 22, 2025, for the decision on the roflumilast foam sNDA.

Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

NCT05028582CompletedPhase 3
Arcutis Biotherapeutics, Inc.
Posted 8/24/2021

FDA Expands Indications for Cerapedics' i-FACTOR Bone Graft in Cervical Spinal Fusion

  • The FDA has approved expanded indications for Cerapedics' i-FACTOR P-15 Peptide Enhanced Bone Graft, enhancing its utility in spinal fusion procedures.
  • i-FACTOR is now approved for single-level ACDF with an allograft bone ring or with PEEK or titanium interbody devices, alongside anterior plate fixation.
  • This expansion underscores Cerapedics' commitment to evidence-based bone grafting, providing surgeons with a proven and safe option for spinal fusion.
  • Backed by Level 1 clinical data, i-FACTOR is the only spinal bone graft powered by P-15 Osteogenic Cell Binding Peptide, ensuring a precise bone-building mechanism.

Clene to Meet with FDA to Discuss Accelerated Approval for CNM-Au8 in ALS

  • Clene will meet with the FDA to discuss accelerated approval of CNM-Au8 for amyotrophic lateral sclerosis (ALS).
  • The meeting will involve senior FDA leadership and experts to discuss ALS biomarkers, clinical endpoints, and survival data related to CNM-Au8.
  • CNM-Au8, a gold nanoparticle suspension, aims to support nerve cell energy needs and has shown potential in slowing ALS progression.
  • Clene is seeking accelerated approval based on data demonstrating CNM-Au8 significantly lowers neurofilament light chain (NfL) levels, a biomarker of nerve cell damage.

Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)

NCT04098406CompletedPhase 2
Clene Nanomedicine
Posted 12/19/2019

HEALEY ALS Platform Trial - Master Protocol

NCT04297683Active, Not RecruitingPhase 2
Merit E. Cudkowicz, MD
Posted 7/14/2020

Eli Lilly's Kisunla (Donanemab) Receives Approval in Japan for Early Alzheimer's Disease

  • Eli Lilly's Kisunla (donanemab-azbt) has been approved in Japan for treating early symptomatic Alzheimer's disease, including mild cognitive impairment.
  • The approval is based on the Phase III TRAILBLAZER-ALZ 2 study, which demonstrated a significant reduction in clinical decline in early-stage patients.
  • Kisunla aims to remove amyloid plaques, potentially allowing patients to discontinue treatment once plaque clearance is achieved, reducing infusion burden.
  • Japan is the second major market to approve Kisunla, offering a new treatment option for the country's rapidly aging population with rising dementia cases.

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

NCT05738486Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 2/28/2023

Re:Cognition Health USA Achieves GCSA Clinical Trial Site Certification

  • Re:Cognition Health USA has earned GCSA Clinical Trial Site Certification, marking them as the first to achieve this in both the US and Europe.
  • The GCSA certification confirms the site's adherence to high-quality global best practices, assessed independently by the IAOCR.
  • This certification covers critical areas like feasibility, study start-up, patient engagement, and workforce process quality.
  • The GCSA quality mark assures sponsors, CROs, staff, and patients of the site's reliability in delivering clinical trials.

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