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Cytokinetics Initiates Phase 1 Trial of CK-4015089 for Muscle Disorders

11/11/2024

Cytokinetics has begun a Phase 1 clinical trial for CK-4015089, a fast skeletal muscle troponin activator (FSTA).

Ascletis Completes Enrollment in Phase III Trial of Denifanstat for Acne

11/12/2024

Ascletis Pharma has completed enrollment of 480 patients in a Phase III clinical trial for ASC40 (denifanstat), an oral tablet for moderate to severe acne.

Sugemalimab Approved by MHRA for First-Line Treatment of Metastatic NSCLC

10/31/2024

Sugemalimab, in combination with platinum-based chemotherapy, has been approved by the UK's MHRA for first-line treatment of metastatic non-small cell lung cancer (NSCLC).

Cytokinetics Initiates Phase 1 Trial of CK-4015089 for Muscle Disorders

11/11/2024

Cytokinetics has begun a Phase 1 clinical trial of CK-4015089, a fast skeletal muscle troponin activator (FSTA).

UAB Launches ADAPT Trial: Adaptive Treatment for Early Smoking Cessation Relapse

9/11/2024

The University of Alabama at Birmingham (UAB) has initiated the ADAPT clinical trial, focusing on adaptive treatment strategies for individuals experiencing early relapse after attempting to quit smoking.

Fentanyl Vaccine Poised for Clinical Trials, Offering Hope in Opioid Crisis

9/1/2024

A fentanyl vaccine developed at the University of Houston is set to enter clinical trials in mid-2025, aiming to prevent the opioid from reaching the brain.

Implantable Sensor Provides Real-Time Monitoring of Inflammation

12/5/2024

Researchers have developed an implantable sensor for continuous, real-time monitoring of inflammation by tracking cytokine levels.

Russia Announces Development of Personalized mRNA Cancer Vaccine

12/14/2024

Russia has developed a personalized mRNA cancer vaccine, expected to be available to patients free of charge starting in early 2025.

EMA's CHMP Recommends Approval of Six New Biosimilars

12/27/2024

The European Medicines Agency's CHMP has recommended approving six new biosimilars, expanding treatment options for various conditions.

Emerging Role of GLP-1 Agonists in Obesity

6/21/2023

GLP-1 agonists, initially developed for type 2 diabetes treatment, have shown significant efficacy in promoting weight loss in both preclinical and clinical studies. This review highlights the role of GLP-1 agonists in weight management, their pleiotropic effects, and their impact on hyperglycemia, insulin sensitivity, blood pressure, and cardio-metabolic and renal protection.

Testing the ProGRESS of Precision Prostate Cancer Screening

1/8/2025

A new precision risk screening tool for prostate cancer, developed by a team of VA, academic, and industry researchers, is being tested in a clinical trial named ProGRESS. This tool aims to improve the accuracy of prostate cancer screening by using individual risk prediction based on family history and genetic markers, potentially reducing unnecessary procedures and addressing health disparities.

Prospective Validation of ORACLE in Lung Adenocarcinoma Prognosis

1/9/2025

A recent study validates the ORACLE prognostic signature for lung adenocarcinoma (LUAD), demonstrating its effectiveness in predicting patient survival and its potential utility in guiding adjuvant therapy decisions. The research leverages multiregion RNA sequencing data from the TRACERx study, highlighting ORACLE's superior performance in tumor sampling bias assessment and its association with overall survival, lung-cancer-specific survival, and disease-free survival.

FDA Approves Epsolay for Inflammatory Lesions of Rosacea

5/24/2022

The FDA has approved Epsolay, a 5% encapsulated benzoyl peroxide cream, for treating inflammatory lesions of rosacea in adults.

Importance of Including Paediatric Experts in Clinical Trials

1/1/2025

Ethics Committees must ensure clinical trials involving children include experts knowledgeable in paediatric, ethical, clinical, and psychosocial issues, as highlighted by recent discussions on protocol deviations and conflicts of interest.

Advances in the Clinical Development of Oncolytic Viruses

6/15/2022

This article reviews the progress in clinical trials of oncolytic viruses (OVs) for cancer treatment, highlighting their safety, effectiveness, and the challenges faced in their development. OVs selectively infect and kill cancer cells without harming normal cells, showing promise in treating various tumors with mild adverse events.

Early Control of Rheumatoid Arthritis Improves Hemostatic Imbalance

1/10/2025

A study published in RMD Open reveals that effective antirheumatic treatments, particularly tocilizumab, significantly improve hemostatic imbalances in newly diagnosed rheumatoid arthritis (RA) patients within the first 24 weeks, potentially reducing elevated thrombosis risks. The research highlights the importance of early treatment and the role of biological drugs in mitigating the procoagulant state in RA patients.

Protection of the Human Gut Microbiome From Antibiotics

11/23/2017

A clinical trial demonstrated that DAV132, a product containing activated charcoal, significantly reduces the exposure of the human gut microbiome to the antibiotic moxifloxacin (MXF) without affecting its plasma pharmacokinetics. The study, involving healthy volunteers, showed that DAV132 could protect the intestinal microbiota's richness and composition from the adverse effects of MXF, suggesting its potential to mitigate the long-term consequences of antibiotic treatments.

FDA Extends Review of GSK's Momelotinib for Myelofibrosis

6/16/2023

The FDA has delayed its decision on GSK's momelotinib, a potential treatment for myelofibrosis, to September 16 to review additional data.

Geopolitical Shifts and Industry Expansion: Navigating the Future of Cell and Gene Therapy in 2025

3/31/2025

Political changes in the UK and Europe may negatively impact university-based gene therapy research, while established pharmaceutical companies are expected to face minimal disruption in 2025.

Duke Study Shows Enzalutamide Combination Extends Survival by 30% in Metastatic Prostate Cancer

5/23/2025

Duke University researchers demonstrated that combining enzalutamide with standard hormonal therapy extends survival by 30% in men with metastatic prostate cancer.

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