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UnitedHealthcare to Require DEX Z-Codes for Molecular Diagnostic Tests in Phase 3

  • UnitedHealthcare will require DEX Z-Codes for certain molecular diagnostic tests under phase 3 of the DEX Z-Codes program, effective for dates of service on or after January 1, 2025.
  • This requirement applies to both facility and professional claims for UnitedHealthcare commercial plans, as part of the updated Molecular Pathology Reimbursement Policy.
  • Laboratories are urged to register with Palmetto's DEX Diagnostics Exchange to obtain the necessary Z-Codes for their tests to ensure reimbursement.
  • Using DEX Z-Codes alongside CPT codes will help identify the test performed and reduce administrative burden related to billing.

Cybin Bolsters Clinical Team as CYB003 Phase 3 Trial Nears

  • Cybin has expanded its clinical team to support the upcoming Phase 3 trial of CYB003 for Major Depressive Disorder (MDD).
  • Key appointments include Dr. Mirza Rahman as SVP, Patient Safety & Pharmacovigilance, and Dr. Marcelo Gutierrez as VP, Clinical Pharmacology.
  • The strengthened team will support pivotal trials across 12 countries, enhancing internal capabilities and pharmacovigilance.
  • CYB003 is a proprietary deuterated psilocin analog being developed as an adjunctive treatment for MDD.

Aurobindo Pharma Gains US FDA Approval for Cephalexin Antibiotic Tablets

  • Aurobindo Pharma has received US FDA approval to manufacture and market Cephalexin Tablets USP in 250 mg and 500 mg dosages, used to treat various infections.
  • The approved tablets are bioequivalent and therapeutically equivalent to Keflet tablets, ensuring similar efficacy and safety profiles for patients.
  • Aurobindo Pharma has been granted competitive generic therapy designation, potentially qualifying the company for 180 days of shared generic drug exclusivity.
  • The launch of Cephalexin tablets is anticipated in the third quarter of fiscal year 2025, expanding Aurobindo's portfolio of generic pharmaceuticals.

PolyPid's D-PLEX100 Phase 3 Trial Reaches Interim Analysis Milestone

  • PolyPid has completed enrollment for the unblinded interim analysis of its SHIELD II Phase 3 trial of D-PLEX100.
  • The trial evaluates D-PLEX100 for surgical site infection prevention in abdominal colorectal surgery patients.
  • Interim analysis results, expected this quarter, could lead to early trial conclusion or sample size re-assessment.
  • Top-line results are anticipated in Q1 2025, with potential for additional funding based on trial outcomes.

FDA Grants Fast Track Designation to Zilganersen for Alexander Disease

• The FDA has granted Fast Track designation to zilganersen for treating Alexander disease (AxD), an ultra-rare neurological disorder. • Zilganersen, developed by Ionis Pharmaceuticals, is the first investigational medicine in clinical trials for AxD, addressing an unmet need. • Topline data from the pivotal Phase 1-3 study of zilganersen is expected in the second half of 2025. • The drug aims to reduce GFAP production, targeting the underlying cause of AxD, which currently has no approved treatments.

A Study to Evaluate the Safety and Efficacy of Zilganersen (ION373) in Patients With Alexander Disease (AxD)

NCT04849741Enrolling by InvitationPhase 3
Ionis Pharmaceuticals, Inc.
Posted 6/1/2021

EDAP TMS Announces First Patients Treated in Phase I/II Study of Focal One HIFU for Benign Prostatic Hyperplasia

  • EDAP TMS has initiated a Phase I/II clinical trial evaluating Focal One robotic HIFU for benign prostatic hyperplasia (BPH) treatment.
  • The study aims to determine optimal treatment parameters using Focal One HIFU to improve BPH symptoms with minimal side effects.
  • The trial is a prospective, multicenter study conducted in two parts, starting in France and potentially expanding to the United States.
  • Focal One's precision in delivering HIFU energy is expected to offer a less invasive BPH treatment option, preserving urethral integrity.

CytoSorbents' DrugSorb-ATR Receives FDA Priority Review for Bleeding Reduction in Heart Surgery

  • CytoSorbents has submitted a De Novo marketing application to the FDA for DrugSorb™-ATR, aimed at reducing perioperative bleeding in CABG surgery patients.
  • The FDA has granted DrugSorb-ATR a Breakthrough Device Designation, making it eligible for priority review and potentially accelerating the approval process.
  • Regulatory decisions from both the FDA and Health Canada regarding DrugSorb-ATR are anticipated in 2025, marking a crucial period for the device's market entry.

Shattuck Labs Prioritizes SL-325, a DR3 Antagonist, for Inflammatory Bowel Disease

  • Shattuck Labs discontinues the clinical program for SL-172154 after modest survival improvements in TP53m AML and HR-MDS patients compared to azacitidine monotherapy.
  • The company will now focus on SL-325, a first-in-class DR3 antagonist antibody, targeting the TL1A/DR3 signaling pathway for inflammatory bowel disease (IBD) treatment.
  • An Investigational New Drug (IND) application for SL-325 is expected to be filed in Q3 2025, with preclinical studies showing high affinity binding and superior efficacy over TL1A antibodies.
  • Restructuring, including a 40% workforce reduction, extends Shattuck's cash runway into 2027, supporting the development of SL-325 through Phase 1 clinical trials.

SPIMA Therapeutics Launches with Exclusive License for Myddosome Inhibitor SPM001

  • SPIMA Therapeutics has secured an exclusive global license agreement with SATT AxLR for SPM001, a peptidic inhibitor targeting the Myddosome complex.
  • SPM001 shows promise as a first-in-class treatment for severe immunological disorders and aggressive cancers driven by MyD88 mutations.
  • SPIMA Therapeutics benefits from strong links with research institutes and the Immun4Cure IHU, providing access to translational and clinical resources.
  • SATT AxLR has invested nearly €1 million in the project, supporting its development from academic innovation to commercial success.

CEL-SCI Partners with Ergomed for Multikine Confirmatory FDA Registration Study in Head and Neck Cancer

  • CEL-SCI has partnered with Ergomed for a confirmatory FDA registration study of Multikine in head and neck cancer, building on prior successful collaborations.
  • The study will enroll 212 patients with locally advanced primary head and neck cancer, focusing on those with no lymph node involvement and low PD-L1 expression.
  • Previous studies showed Multikine improved 5-year survival rates to 73% compared to 45% in the control group for the target population.
  • The confirmatory study is set to commence in Q1 2025 across multiple countries, marking a crucial step toward potential marketing approval.

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