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Clinical Trial News

Compremium Launches First-in-Human Study of Non-Invasive Thyroid Cancer Diagnostic Device

  • Swiss medtech company Compremium has initiated a first-in-human clinical study testing a novel non-invasive diagnostic device that measures tissue compressibility to distinguish between benign and malignant thyroid nodules.
  • The 18-month study will enroll up to 30 patients with Bethesda IV thyroid nodules at Bern University Hospital, targeting a patient population where only 25-40% of nodules are ultimately cancerous despite many undergoing precautionary surgery.
  • The CPMX2 system aims to reduce unnecessary thyroidectomies by providing real-time visualization of tissue stiffness, potentially addressing the current 75% false-positive rate in Bethesda IV nodule classification.
  • Compremium's FDA-cleared technology has been validated in over 40 clinical studies and shows promise across more than 30 medical indications beyond thyroid diagnostics.

FDA Issues Warning Letter to Whoop Over Unapproved Blood Pressure Feature

  • The FDA has issued a warning letter to Whoop alleging the company is marketing its Blood Pressure Insights feature without proper medical device approvals.
  • Whoop maintains the feature remains available to Life tier subscribers and argues the FDA is overstepping its authority by regulating a wellness feature as a medical device.
  • The dispute centers on whether blood pressure monitoring constitutes medical diagnosis versus wellness tracking, with significant regulatory and financial implications for wearable technology companies.

Omniscope Pioneers Immune Profiling Breakthrough for Personalized Pediatric Cancer Therapy

  • Omniscope and partners published a landmark study in Annals of Oncology demonstrating successful immune profiling in a <1-year-old patient with renal rhabdoid tumor, a rare and aggressive pediatric cancer.
  • The team used proprietary immune profiling technology to track T cell dynamics across tumor and blood compartments, identifying tumor-reactive T cells with high precision to inform immunotherapy response.
  • This breakthrough enables the design of personalized second-line cell therapies using TCR-T engineering, marking a significant advancement toward precision oncology for rare pediatric cancers.
  • The study demonstrates how real-time immune monitoring combined with liquid biopsy can predict therapy outcomes and accelerate personalized treatment development for diseases where standard treatments fail.

FDA Advisory Panel Votes Against GSK's Blenrep for Multiple Myeloma Over Eye Safety Concerns

Drug ApprovalOncology
  • FDA advisers voted that the risks of GSK's blood cancer drug Blenrep outweigh its benefits in treating multiple myeloma, citing serious eye-related side effects as a primary concern.
  • The drug causes ocular toxicity that represents "unique toxicity not seen with any currently available treatments for multiple myeloma," according to FDA staff reviewers.
  • FDA staff suggested that lower dosages of Blenrep could offer patients similar efficacy while reducing the risk of side effects, questioning the company's selected dose.
  • The FDA is expected to make its final approval decision by next week, though the agency does not have to follow the advisory panel's recommendation.

bioAffinity Technologies Secures International Patents for CyPath Lung Cancer Diagnostic in China and Canada

AI
  • bioAffinity Technologies received patent approvals in China and Canada for its CyPath Lung diagnostic platform, which uses flow cytometry analysis of sputum to detect lung cancer.
  • The CyPath Lung test demonstrates 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small nodules less than 20 millimeters.
  • China represents a significant market opportunity with over 300 million smokers and 1.06 million new lung cancer cases diagnosed in 2022, while Canada sees approximately 31,000 new cases annually.
  • The patents protect the use of defined antibodies and porphyrin TCPP to label cell populations in sputum, strengthening the company's global intellectual property portfolio.

Sun Pharma's Halol Plant Fails Another FDA Inspection Over Contamination Concerns

  • Sun Pharmaceutical's manufacturing facility in Halol, India failed another FDA inspection last month due to serious quality control issues and contamination concerns.
  • The FDA issued a 19-page report detailing problems with sterility, environmental conditions, and cleanliness practices at the world's largest generic drugmaker's key facility.
  • This latest inspection failure continues a pattern of regulatory violations at the plant dating back nearly a decade, raising ongoing concerns about the company's ability to ensure proper manufacturing standards.
  • The inspection findings highlight persistent difficulties in following proper procedures and preventing medicine contamination at this critical Sun Pharma production site.

FDA Raises Eye Safety Concerns for GSK's Blenrep Ahead of Advisory Committee Review

Drug Approval
  • The FDA has identified significant ocular toxicity concerns with GSK's Blenrep (belantamab mafodotin) ahead of a July 17 advisory committee meeting to review the drug's reintroduction to the U.S. market.
  • Clinical trials DREAMM-7 and DREAMM-8 showed that 92-93% of patients experienced keratopathy and visual acuity events, with 77-78% experiencing serious grade 3-4 events.
  • GSK withdrew Blenrep from the U.S. market in 2022 after confirmatory trial shortcomings, despite initial FDA approval in 2020 for multiple myeloma treatment.
  • The company's stock fell 1.19% following the FDA briefing document release, as eye safety concerns represent a unique toxicity profile among multiple myeloma therapies.

Egetis Therapeutics Advances Toward US NDA Submission for Tiratricol Following FDA Breakthrough Therapy Designation

Orphan DrugRare Disease
  • The FDA granted Breakthrough Therapy Designation to Egetis Therapeutics' tiratricol in July 2025 for treating MCT8 deficiency, based on survival data showing significant improvement in treated versus untreated patients.
  • Egetis has submitted a pre-NDA meeting request to the FDA to discuss the contents and timing of the US NDA submission for tiratricol, with plans to initiate the submission during 2025.
  • The ReTRIACt study currently has 15 evaluable patients enrolled, and tiratricol has already received EU approval as Emcitate in February 2025 for MCT8 deficiency treatment.
  • MCT8 deficiency is a rare genetic disorder affecting fewer than 1,000 individuals globally with no previously approved therapies, representing a significant unmet medical need.

Withdrawal of Tiratricol Treatment in Males with Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency)

NCT05579327RecruitingPhase 3
Rare Thyroid Therapeutics International AB
Posted 7/21/2023

Evestia Clinical Merges with Atlantic Research Group to Create Global Specialist CRO

NeurologyOncology
  • Evestia Clinical (formerly EMAS Pharma) has merged with US-based Atlantic Research Group to create an independent global specialist CRO group in fast-growing markets.
  • The merger more than doubles Evestia Clinical's size by headcount and service delivery capability while expanding its US footprint and therapeutic offerings to include neurology and late-stage clinical trials.
  • The combined group will provide full clinical trial services from Phase 1 through Phase 3 and beyond, with enhanced technologies and specialized services across multiple therapeutic areas.
  • Following integration, the enlarged group will be headquartered in the UK (Letchworth) and USA (Charlottesville, VA) with global capabilities through its network of offices and expert partners.

FDA Approves Kirsty as First Interchangeable Rapid-Acting Insulin Aspart Biosimilar

Drug Approval
  • The FDA has approved Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar to NovoLog, expanding treatment options for diabetes patients.
  • Kirsty can be substituted for NovoLog at the pharmacy without a new prescription, potentially streamlining access and driving competition in the insulin market.
  • The approval addresses critical access issues for over 8.4 million Americans dependent on insulin therapy, with studies showing 1 in 5 adults under 65 ration insulin due to cost.
  • Biocon Biologics' second interchangeable insulin biosimilar builds on their diabetes portfolio, following Semglee as the first approved interchangeable biosimilar insulin.

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