Keymed Biosciences' Stapokibart Receives NMPA Approval for Seasonal Allergic Rhinitis and Chronic Rhinosinusitis with Nasal Polyposis
Keymed Biosciences' Stapokibart (Kangyueda) has been approved by China's NMPA for seasonal allergic rhinitis, expanding its therapeutic applications.
Digital Twins Accurately Predict Cancer Treatment Effectiveness in Virtual Trials
Digital twins, created from biological data of thousands of cancer patients, accurately predicted outcomes in simulated clinical trials, offering a potential tool for virtual drug testing.
Dimerix's ACTION3 Phase 3 Trial for FSGS Receives Positive IDMC Review
The Independent Data Monitoring Committee (IDMC) completed its fifth review of Dimerix's ACTION3 Phase 3 clinical trial data, with no safety concerns identified.
Rallybio Advances RLYB212 Phase 2 Trial for FNAIT Prevention in Pregnant Women
Rallybio has initiated a Phase 2 clinical trial for RLYB212, a potential treatment for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT).
Myriad Genetics and MD Anderson Form 5-Year Strategic Alliance
The University of Texas MD Anderson Cancer Center and Myriad Genetics have announced a five-year strategic alliance aimed at accelerating the clinical evaluation and development of Myriad’s molecular residual disease (MRD) assay. This collaboration will focus on investigating the test's utility in various cancers, with the goal of supporting its inclusion in national guidelines and adoption by healthcare providers.
Pila Pharma Advances PP-CT03 Trial for XEN-D0501 in Type 2 Diabetes and Obesity
Pila Pharma has selected Cambridge University Hospital as the principal clinical trial site for PP-CT03, focusing on XEN-D0501.
Clearmind Medicine Receives IRB Approval for CMND-100 Alcohol Use Disorder Trial
Clearmind Medicine has secured IRB approval for its Phase I/IIa clinical trial of CMND-100, a MEAI-based treatment for alcohol use disorder (AUD).
FDA Accepts Abeona Therapeutics' BLA Resubmission for Prademagene Zamikeracel in RDEB Treatment
The FDA has accepted Abeona Therapeutics' resubmitted Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB).
CRISPR Breakthrough: Israeli Team Eliminates 50% of Head and Neck Tumors by Targeting Single Gene
Tel Aviv University researchers have successfully used CRISPR gene-editing technology to eliminate 50% of head and neck tumors in model animals by targeting the SOX2 gene, challenging previous assumptions about CRISPR's limitations in cancer therapy.
Evaluation of the One-Step Nucleic Acid Amplification Method for Rapid Detection of Lymph Node Metastases in Endometrial Cancer
A prospective, multicenter study evaluates the diagnostic performance of the one-step nucleic acid amplification (OSNA) method for detecting sentinel lymph node (SLN) metastases in early-stage endometrial cancer, comparing it with standard ultrastaging. The study found that OSNA has high specificity and accuracy, offering the advantage of analyzing the entire lymph node to eliminate sampling bias.
Novel Immunotherapy Combination Shows Promise Against Melanoma and Breast Cancer Metastases
Researchers at Medical University of Vienna have developed a promising combination therapy using interferon-I and imiquimod that effectively targets both local tumors and distant metastases. The treatment showed significant potential in melanoma and breast cancer models by triggering tumor cell death and activating the adaptive immune system, potentially offering new hope for patients with superficial tumors.
Intrepid Valve Trial Shows Promise for Mitral Regurgitation Patients with Annular Calcification
A clinical trial using the Intrepid valve significantly improved the quality of life for a patient with mitral regurgitation (MR) and mitral annular calcification (MAC).
Experimental Drug K884 Enhances Muscle Stem Cell Repair in Duchenne Muscular Dystrophy
Researchers at McGill University discovered that K884 enhances muscle stem cell repair in Duchenne muscular dystrophy (DMD).
FDA Accepts Resubmission of NDA for Oral Sulopenem in Uncomplicated UTIs
The FDA has accepted Iterum Therapeutics' resubmitted New Drug Application (NDA) for oral sulopenem for treating uncomplicated urinary tract infections (uUTIs).
Reappraisal of US Clinical Trials on Post-Treatment Lyme Disease Syndrome
Two out of four U.S. treatment trials demonstrated the efficacy of IV ceftriaxone on primary and/or secondary outcome measures for post-treatment Lyme fatigue.
Savara Announces Presentation of Phase 3 IMPALA-2 Trial Results for Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
Savara Inc. will present results from the Phase 3 IMPALA-2 trial of inhaled molgramostim at the British Thoracic Society Winter Meeting.
CHI-RON Study Aims to Improve Outcomes for Adults with Congenital Heart Defects
The CHI-RON study seeks to redefine outcomes and improve care navigation for adults with congenital heart defects.
FDA Extends Review of Organon's VTAMA for Atopic Dermatitis
The FDA has extended the review period for Organon's sNDA for VTAMA (tapinarof) cream, 1% for treating atopic dermatitis (AD) in adults and children aged two and older.
Beta-Blockers Offer New Hope for Huntington's Disease Patients
A recent study from the University of Iowa suggests that beta-blockers, commonly used for heart conditions, may slow the progression of Huntington's disease. This finding is significant as it offers hope for delaying symptom onset and slowing disease progression in affected individuals. The research team plans to conduct clinical trials specifically for Huntington's, leveraging the safety and affordability of these well-understood medications.
FDA Approvals Expand Amivantamab's Role in EGFR-Mutated NSCLC Treatment
The FDA has granted multiple approvals for amivantamab in EGFR-mutated non-small cell lung cancer, including monotherapy and combination treatments based on pivotal clinical trials.