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Clinical Trial News

China's NMPA Proposes Streamlined 30-Day Review Channel for Category 1 Innovative Drugs

  • China's National Medical Products Administration (NMPA) is seeking public comments on a draft proposal to optimize clinical trial review and approval processes for innovative drugs.
  • The proposed 30-day review channel would be available for Category 1 innovative drugs including traditional Chinese medicine, chemical drugs, and biological products that meet specific criteria.
  • Eligible drugs must be key innovative drugs with national support and submit complete application materials according to regulatory requirements.
  • This regulatory streamlining initiative aims to accelerate the development pathway for China's most promising therapeutic innovations.

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.

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