MedPath

Clinical Trial News

PathPresenter Receives FDA 510(k) Clearance for Digital Pathology Clinical Viewer

Precision Medicine
  • PathPresenter has received FDA 510(k) clearance for its Clinical Viewer platform, enabling primary diagnosis using digital pathology workflows.
  • The clearance is specifically for use with Hamamatsu NanoZoomer S360MD slide scanners and Barco NV MDPC-8127 display devices.
  • The platform addresses a critical need in healthcare, as pathology guides nearly 70% of clinical decision-making processes.
  • This regulatory milestone advances the adoption of digital workflows in pathology and supports precision medicine initiatives.

Cigna Sues Bristol Myers Squibb Over Alleged Monopoly Practices for Cancer Drug Pomalyst

  • Cigna filed a federal lawsuit against Bristol Myers Squibb, alleging the company used anti-competitive strategies to maintain a monopoly on Pomalyst, a multiple myeloma treatment that generated $2.7 billion in U.S. sales last year.
  • The insurer claims Bristol Myers' subsidiary Celgene filed sham patent lawsuits and paid off generic manufacturers to prevent lower-cost alternatives from entering the market.
  • Cigna alleges Celgene defrauded the U.S. Patent and Trademark Office by withholding information about an existing patent and claiming unexpected positive results to strengthen patent protections.
  • The lawsuit seeks triple damages for alleged overcharges of "many hundreds of millions, if not billions, of dollars" caused by the monopolistic practices.

Trinity Biotech Receives WHO Approval for Offshore Manufacturing of HIV Rapid Test

  • Trinity Biotech received World Health Organization approval for offshored and outsourced upstream manufacturing of its TrinScreen HIV rapid test, marking a critical milestone in the company's transformation plan.
  • The regulatory approval enables transition from legacy in-house operations to a more cost-effective and scalable outsourced model while maintaining product integrity and regulatory compliance.
  • The strategic move is expected to deliver substantial improvements in gross margin and working capital while enhancing supply chain resilience and scalability.
  • Trinity Biotech plans to implement this new TrinScreen HIV manufacturing model in Q3 2025 as part of broader efforts to streamline operations and reduce fixed costs.

Phase 3 Trial Shows Olanzapine Significantly Reduces Chemotherapy-Induced Nausea and Vomiting in Breast Cancer Patients

  • A phase 3 trial demonstrated that adding 5 mg olanzapine to standard triplet antiemetic therapy significantly improved complete response rates for chemotherapy-induced nausea and vomiting in breast cancer patients receiving anthracycline plus cyclophosphamide chemotherapy.
  • The olanzapine group achieved a 58.1% complete response rate compared to 35.5% with placebo, representing a 22.7% difference with statistical significance (P <.0001).
  • The treatment showed acceptable safety profile with the most common severe adverse events being anorexia and constipation, while providing substantial advancement in managing chemotherapy-induced nausea and vomiting.

Curiteva Receives FDA 510(k) Clearance for First 3D-Printed PEEK Standalone Spinal Implant

  • Curiteva secured FDA 510(k) clearance for the Inspire Trabecular PEEK Standalone ALIF system, marking the first-ever 3D printed PEEK standalone implant with HAFUSE technology.
  • The implant features fully integrated porosity, exceptional radiographic visibility, and optimal biomechanical properties engineered to promote osseointegration across the entire construct.
  • Dr. Stephen Tolhurst from Texas Back Institute reported striking results over two years of use, with visual confirmation of bone growth both on and through the implant.
  • The rapid regulatory approval was facilitated by Curiteva's proprietary FDA Master File for Inspire technology, building on previous success with the Inspire Lumbar Interbody clearance.

Breckenridge Pharmaceutical Receives FDA Approval for Generic Dehydrated Alcohol Injection for Hypertrophic Obstructive Cardiomyopathy

Drug ApprovalRare Disease
  • Breckenridge Pharmaceutical received FDA approval for its generic version of Ablysinol, a dehydrated alcohol injection used to treat symptomatic hypertrophic obstructive cardiomyopathy in patients unsuitable for surgical myectomy.
  • The sterile, preservative-free solution contains ≥99% ethyl alcohol and is indicated for inducing controlled cardiac septal infarction to improve exercise capacity in adult HOCM patients.
  • This approval positions Breckenridge as one of the first companies to offer a generic alternative to Ablysinol in the U.S. market, supporting the company's strategy to expand its institutional healthcare presence.
  • The product will be available primarily in hospitals, clinics, and home health care facilities, reflecting Breckenridge's commitment to providing affordable treatment options for rare disease patients.

Duvelisib-Romidepsin Combination Shows 61% Response Rate in Relapsed T-Cell Lymphomas

Real World Evidence
  • A real-world study by Mass General Brigham's PETAL Consortium demonstrated that the combination of duvelisib and romidepsin achieved a 61% overall response rate in 38 patients with relapsed/refractory T-cell lymphomas.
  • The treatment enabled 11 patients to proceed to stem cell transplantation, with 47% achieving complete response and no detectable cancer.
  • Patients with nodal T-follicular helper cell subtype showed particularly strong results with an 82% response rate to the combination therapy.
  • Despite manageable side effects and the need for dose modifications, the study provides evidence for this novel therapeutic strategy in aggressive blood cancers that resist standard treatment.

Tirzepatide Shows Promise for Type 1 Diabetes in Off-Label Use Study

  • A retrospective study presented at ADA 2025 found that off-label tirzepatide use in type 1 diabetes patients resulted in significant weight reduction of 6.7 kg after 3 months.
  • Participants were able to reduce their total daily insulin dose by 21.6 units, primarily through reductions in bolus insulin doses.
  • Time in range improved significantly from 54.9% to 60.8%, suggesting better glycemic control despite reduced insulin requirements.
  • Researchers emphasized that while results are promising, randomized controlled trials are needed to confirm these benefits for type 1 diabetes patients.

ForSight Robotics Raises $125M Series B to Advance ORYOM Robotic Eye Surgery Platform

AI
  • ForSight Robotics completed a $125M Series B funding round led by Eclipse to accelerate development of the ORYOM Platform, the world's first robotic surgery system for cataract and other eye diseases.
  • The company plans to launch first-in-human clinical trials this year, addressing a global crisis where over 600 million patients suffer from cataracts but only 30 million receive surgical treatment annually.
  • The ORYOM Platform utilizes AI-based algorithms, advanced computer vision, and micromechanics to provide unprecedented precision for ophthalmic procedures, with capability to access both anterior and posterior eye segments.
  • The funding brings ForSight Robotics' total funding to $195M as the company doubles in size to over 110 employees and prepares to tackle the projected 12% decline in ophthalmologists by 2035.

Abridge Secures $300M Series E Funding, Reaches $5.3B Valuation for AI Clinical Documentation Platform

AI
  • Abridge raised $300 million in Series E funding led by Andreessen Horowitz, bringing its valuation to $5.3 billion for its ambient listening technology that automates clinical documentation.
  • The AI-powered platform serves over 150 health systems including Kaiser Permanente, UPMC, and Sutter Health, generating clinical notes from medical conversations across 55 specialties and 28 languages.
  • The company reports significant clinical impact with 60-70% reduction in burnout and over 90% clinician retention rate, while projecting support for more than 50 million medical conversations in 2025.
  • This funding round follows a $250 million raise in February, representing one of the most substantial health tech deals of 2024 as AI scribes gain rapid adoption to address clinician burnout.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.