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Clinical Trial News

DermaRite Industries Recalls Four OTC Products Due to Life-Threatening Burkholderia Cepacia Contamination

  • DermaRite Industries voluntarily recalled four over-the-counter healthcare products nationwide due to microbial contamination with Burkholderia cepacia, which can cause serious and life-threatening infections.
  • The contaminated products pose particular risk to immunocompromised individuals who may develop bloodstream infections leading to sepsis, while healthy individuals with minor skin lesions face risk of local infections.
  • The recalled products include DermaKleen antiseptic lotion soap, DermaSarra external analgesic, KleenFoam antimicrobial foam soap, and PeriGiene antiseptic cleanser, all distributed nationwide in the United States and Puerto Rico.
  • No adverse events have been reported to date related to this recall, and the company has notified distributors and customers to immediately examine inventory and destroy affected products.

FDA Issues Safety Alerts for Boston Scientific Heart Devices Linked to 33 Deaths

  • The FDA issued safety alerts for two Boston Scientific heart devices, with the Endotak Reliance defibrillator wires linked to 386 serious injuries and 16 deaths due to calcification causing shock delivery failures.
  • The Watchman stroke prevention device has been associated with 120 serious injuries and 17 deaths related to increased blockage risks during implantation procedures under certain anesthesia levels.
  • Boston Scientific's heart device business represents two-thirds of its $5 billion quarterly revenue, with company shares falling 1.8% following the FDA announcements.
  • The Endotak Reliance wires were distributed from 2002 to 2021 and are no longer available, while some patients may require device replacement procedures.

CorMedix Acquires Melinta Therapeutics for $300 Million to Expand Anti-Infective Portfolio

  • CorMedix has entered a definitive agreement to acquire Melinta Therapeutics for $300 million, adding seven marketed infectious disease products to its portfolio.
  • The acquisition includes Rezzayo, currently approved for candidemia treatment with an ongoing Phase III study for fungal infection prophylaxis expected to complete in first half 2026.
  • Melinta's portfolio generated $120 million in revenue in 2024 and is projected to deliver $125-135 million for fiscal year 2025.
  • The transaction is expected to achieve annual run-rate synergies of $35-45 million and be highly accretive in 2026.

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

NCT04368559RecruitingPhase 3
Mundipharma Research Limited
Posted 5/11/2020

REGENXBIO Initiates Pivotal Phase IIb/III Trial for Diabetic Retinopathy Gene Therapy

Rare Disease
  • REGENXBIO has initiated a pivotal Phase IIb/III clinical trial for diabetic retinopathy, marking a significant advancement in gene therapy for this vision-threatening complication.
  • The company's shares rose 1.27% after-hours following the announcement of the trial initiation, reflecting investor confidence in the therapeutic approach.
  • REGENXBIO continues to advance its pipeline with Duchenne muscular dystrophy trials on track and MPS II gene therapy progressing toward BLA submission.
  • Multiple investment firms maintain positive ratings on REGENXBIO stock, with Barclays maintaining an Overweight rating despite some price target adjustments across analysts.

Poxel Enters Reorganization Proceedings as Clinical-Stage Biotech Faces Financial Restructuring

  • Poxel SA, a clinical-stage biopharmaceutical company developing treatments for metabolic diseases, has entered judicial reorganization proceedings following a court hearing on August 5, 2025.
  • The company will continue operations during a six-month observation period while exploring options including a continuation plan to maintain its drug development activities.
  • Poxel's pipeline includes PXL065 for MASH treatment, which met its primary endpoint in the Phase 2 DESTINY-1 trial, and PXL770 for rare metabolic disorders.
  • Trading of Poxel shares on Euronext Paris resumed on August 11, 2025, following the court's decision to initiate the reorganization process.

Radella Pharmaceuticals' MD-18 Demonstrates 2.7% Weight Loss and Cardiometabolic Benefits in Phase 1b Trial

  • Radella Pharmaceuticals' Phase 1b trial of MD-18 showed 2.7% weight loss in healthy participants over 28 days without titration.
  • The first-in-class peptide targets PTP1B enzymes to enhance insulin sensitivity and energy expenditure while preserving lean muscle mass.
  • MD-18 demonstrated additional cardiometabolic benefits including reduced LDL cholesterol and decreased alanine aminotransferase levels.
  • The company plans to expand trials to include overweight patients and those with type 2 diabetes in upcoming 12-week studies.

RBL Secures Investment from Modi Ventures to Accelerate Biotech Venture Creation

  • RBL, a biotech venture creation studio, received investment from Modi Ventures to support launching and scaling startups into clinical-stage companies.
  • Sahir Ali, founder of Modi Ventures, joined RBL's board of directors to bridge academic biotech research with clinical care markets.
  • Modi Ventures manages $134 million and invests in AI-driven drug discovery, diagnostics, and engineered therapeutics companies.
  • The investment validates RBL's venture creation model and reinforces Houston's growing reputation as a biotech innovation hub.

Novel PDE4 Inhibitor ME3183 Demonstrates Significant Efficacy in Phase 2 Plaque Psoriasis Trial

  • ME3183, a novel oral phosphodiesterase 4 inhibitor, achieved statistically significant PASI75 response rates of 61% at the optimal 7.5 mg twice daily dose in a 16-week phase 2 trial.
  • The study enrolled 132 patients with moderate to severe plaque psoriasis across 27 sites in the US and Canada, with the 7.5 mg cohort showing the highest mean PASI reduction of -85.8%.
  • Common adverse events included diarrhea, nausea, and headache, with most being mild to moderate, though 13 patients discontinued treatment due to side effects.
  • The results address an unmet medical need for oral psoriasis therapies, given the global burden of 4 million psoriasis cases requiring effective treatment options.

Dana-Farber Researchers Develop SWIFT-seq Blood Test to Replace Bone Marrow Biopsies in Multiple Myeloma

Precision Medicine
  • Researchers at Dana-Farber Cancer Institute have developed SWIFT-seq, a blood test that uses single-cell sequencing to profile circulating tumor cells and could replace painful bone marrow biopsies for multiple myeloma diagnosis and monitoring.
  • The test successfully captured circulating tumor cells in 90% of patients with MGUS, SMM, and multiple myeloma, with detection rates of 95% in SMM patients and 94% in newly diagnosed multiple myeloma patients.
  • SWIFT-seq provides comprehensive genetic profiling, tumor growth assessment, and prognostic gene signatures from a single blood sample, offering superior accuracy compared to traditional FISH testing methods.
  • The breakthrough could transform patient care by enabling routine, non-invasive monitoring and risk stratification while providing novel insights into myeloma biology that may lead to new therapeutic approaches.

Iovance Biotherapeutics Withdraws Amtagvi EU Filing, Stock Plunges 29% Despite Strong Q2 Sales

  • Iovance Biotherapeutics voluntarily withdrew its European Union regulatory filing for Amtagvi due to lack of alignment with the EMA on clinical data supporting the submission.
  • The company reported strong Q2 Amtagvi sales of $54.1 million, beating estimates and driven by over 100 patient infusions during the quarter.
  • Shares plummeted nearly 29% in after-market trading following the EMA withdrawal announcement, contributing to a 64% year-to-date decline.
  • The company announced a strategic restructuring plan to save over $100 million annually, including laying off 19% of its workforce by next month.

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