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Clinical Trial News

Hera Biotech Acquires HeraFem Point-of-Care Cervical Cancer Diagnostic with 91% Sensitivity

AI
  • Hera Biotech has acquired HeraFem, a point-of-care cervical cancer diagnostic device that achieves 91% sensitivity for detecting CIN2+ lesions using electrical and optical spectroscopy with AI algorithms.
  • The acquisition expands Hera Biotech's platform beyond endometriosis to address cervical cancer, which causes approximately 350,000 global annual deaths with 94% occurring in low- and middle-income countries.
  • HeraFem eliminates the need for sample collection and provides immediate, same-visit diagnosis, addressing limitations of traditional Pap tests that have 55-80% sensitivity for detecting high-grade lesions.
  • The company has secured distribution partners and pre-orders across Central and South America while pursuing U.S. regulatory pathways to scale commercialization globally.

SmartLabs and IWG Form 10-Year Partnership to Expand Global Lab Infrastructure Access

  • SmartLabs and International Workplace Group announced a 10-year global partnership to integrate fully managed laboratory solutions across IWG's flexible workspace portfolio in over 120 countries.
  • The collaboration will deliver comprehensive lab-as-a-service capabilities including site selection, design, construction management, and ongoing scientific support to underserved life sciences markets worldwide.
  • The partnership addresses rising global demand for R&D space while helping biotech and pharmaceutical companies reduce time to operational readiness and focus resources on scientific innovation.

EVerZom Secures €3 Million France 2030 Funding to Scale Exosome Bioproduction for Crohn's Disease Treatment

  • EVerZom received €3 million in government funding through France 2030's "Biotherapies and Bioproduction" program to industrialize its exosome bioproduction platform.
  • The funding will enable scale-up to 50L GMP bioreactors, reaching production levels compatible with late-stage clinical phases and market launch.
  • EVerGel, the company's lead candidate for Crohn's disease perianal fistulas, achieved 87.5% complete healing in preclinical porcine models compared to 12.5% in controls.
  • The exosome-based therapy could enter clinical trials by 2026 with target commercialization by 2030 for a condition affecting nearly 2 million patients worldwide.

Beyond Air Submits FDA Application for Next-Generation LungFit PH II Nitric Oxide System

  • Beyond Air has submitted a premarket approval supplement to the FDA for LungFit PH II, a next-generation therapeutic nitric oxide generator designed to be smaller, lighter, and fully transport-ready.
  • The new system maintains all breakthrough features of the currently FDA-approved LungFit PH while offering reduced weight and footprint, simplified operation, and full compatibility with air and ground transport.
  • The device targets persistent pulmonary hypertension of the newborn (PPHN), a lethal condition affecting 1.9 per 1,000 live births with mortality rates ranging between 4-33%.
  • LungFit PH II uses patented Ionizer technology to generate unlimited on-demand nitric oxide from ambient air, potentially replacing large high-pressure NO cylinders in hospital settings.

Clarity Pharmaceuticals Secures Major Manufacturing Deal to Scale Cu-SAR-bisPSMA Production for Prostate Cancer Diagnostics

  • Clarity Pharmaceuticals has entered a five-year commercial manufacturing agreement with SpectronRx to produce up to 400,000 patient-ready doses of Cu-SAR-bisPSMA annually for prostate cancer diagnosis and treatment.
  • The partnership leverages copper-64's optimal 12.7-hour half-life to overcome supply chain limitations of current-generation PSMA diagnostics that rely on shorter-lived isotopes like gallium-68 and fluorine-18.
  • The agreement positions Clarity for immediate commercial rollout upon FDA approval of its Phase III registrational trials CLARIFY and AMPLIFY, with distribution capabilities to all 50 US states.
  • SpectronRx's Indiana facility will provide integrated manufacturing of both copper-64 isotope and the finished Cu-SAR-bisPSMA product under one roof, with options to expand to additional regional manufacturing sites.

BiomX Achieves Breakthrough in Phage Therapy with Positive Phase 2 Results for Antibiotic-Resistant Infections

Orphan Drug
  • BiomX Inc. reported positive Phase 2 results for diabetic foot osteomyelitis, achieving statistically significant ulcer size reduction with p-values of 0.046 at week 12 and 0.052 at week 13.
  • The company's cystic fibrosis program showed 14.3% of patients completely cleared chronic P. aeruginosa infections after 10 days of treatment, compared to 0% in the placebo group.
  • BiomX has received $40 million in non-dilutive funding from the U.S. Defense Health Agency and FDA Fast Track and Orphan Drug designations for its phage therapy programs.
  • Wall Street analysts maintain Buy ratings with price targets of $15-16, representing potential upside of over 3000% from current trading levels around $0.4.

Health Canada Approves Abbott's Rapid Whole Blood Test for Concussion Assessment

  • Health Canada has approved Abbott's i-STAT TBI test cartridge for use with whole blood, enabling clinicians to assess suspected concussions at the patient's bedside with lab-quality results in 15 minutes.
  • The approval expands testing capabilities beyond hospital emergency departments to urgent care clinics and potentially pharmacies, clinics without radiology, and sporting event sidelines.
  • The test measures two brain-specific biomarkers (UCH-L1 and GFAP) and can help rule out the need for CT scans when biomarker levels are below established thresholds.
  • This authorization allows evaluation of patients up to 24 hours post-injury, addressing situations where individuals may delay seeking medical attention for head trauma.

Clinical Trial Activity Plummets 20% as Funding Crisis Grips Biotech Sector

Oncology
  • Clinical trial registrations have declined by 20% year-over-year according to analysis of ClinicalTrials.gov and Australian/New Zealand registries, with oncology trials experiencing the most severe impact at approximately 60% reduction.
  • Biotech companies are increasingly shifting early-phase trials to ex-US locations including Australia, Asia-Pacific, Eastern Europe, and China due to favorable regulatory environments, reduced costs, and faster timelines.
  • The funding environment has returned to 2019 levels following the post-COVID bubble, with an 18% reduction in publicly traded biotechs over the past 40 months making it extremely difficult to raise capital for Phase II and III studies.
  • Despite the overall decline, obesity and RNA-based therapeutics continue to retain investor interest and show resilience in the current challenging market conditions.

Thyroid Cancer Pipeline Shows Robust Growth with 50+ Companies Developing Novel Therapies

Monoclonal AntibodyCAR-T
  • DelveInsight's 2025 pipeline report reveals over 50 companies are actively developing 51+ therapies for thyroid cancer treatment, indicating a robust therapeutic landscape.
  • Novartis announced a Phase III study evaluating dabrafenib plus trametinib for BRAFV600E mutation-positive differentiated thyroid cancer patients refractory to radioactive iodine.
  • Children's Hospital of Philadelphia initiated a study combining larotrectinib with 131I therapy for NTRK fusion differentiated thyroid cancer patients.
  • Emerging therapies include CAR-T cell therapy AIC100 from AffyImmune Therapeutics and novel BRAF inhibitor RX208 from Suzhou NeuPharma.

Purdue Pharma Secures $7.4 Billion Opioid Settlement Support from 55 States and Territories

  • Purdue Pharma and the Sackler family have secured support from 55 U.S. states and territories for a $7.4 billion settlement to resolve thousands of opioid lawsuits related to OxyContin.
  • The settlement includes approximately $6.5 billion from the Sackler family and $900 million from Purdue Pharma, with payouts beginning after creditor approval of the Chapter 11 reorganization plan.
  • Unlike a previous rejected settlement, this agreement does not provide the Sacklers with broad immunity from future opioid-related civil lawsuits.
  • The funds will be distributed to individuals, state and local governments, and Native American tribes over 15 years to address the opioid crisis that has caused over 850,000 deaths since 1999.

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