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Real-World Evidence Oncology Market Projected to Reach $3.51 Billion by 2035 with 14.7% CAGR

Real World EvidenceOncologyAIPrecision Medicine
  • The real-world evidence oncology solutions market is projected to grow from $893 million in 2025 to $3.51 billion by 2035, representing a compound annual growth rate of 14.7%.
  • Market growth is driven by increasing demand for real-world evidence in drug development, rising focus on value-based healthcare, growing global cancer incidence, and advancements in data analytics and AI technologies.
  • North America is expected to hold the largest market share in 2025, while the Asia-Pacific region is projected to experience the fastest growth during the forecast period.
  • The datasets segment is expected to account for the largest market share, while pharmaceutical, biotechnology, and medical device companies represent the primary end-user segment.

Dual-Modal Approach Combining OCT and Raman Spectroscopy Achieves 97% Accuracy in Skin Cancer Detection

AIOncology
  • A novel dual-modal approach combining optical coherence tomography (OCT) and Raman spectroscopy has demonstrated 96.9% accuracy in differentiating melanoma from benign lesions when paired with machine learning algorithms.
  • Early melanoma detection significantly impacts patient outcomes, with 5-year survival rates dropping from 99% in early-stage cases to just 35% when the cancer metastasizes to distant organs.
  • This non-invasive diagnostic technique could potentially reduce reliance on painful biopsies while providing clinicians with more objective and rapid diagnostic capabilities for skin cancer.

FDA Approves Theratechnologies' EGRIFTA SV Prior Approval Supplement and Alpha Tau's Trial for Recurrent Glioblastoma

FDA ApprovalOncology
  • Theratechnologies has received FDA approval for a Prior Approval Supplement (PAS) for EGRIFTA SV, paving the way for its replacement with the new EGRIFTA WR formulation while ensuring continued distribution of EGRIFTA SV.
  • Alpha Tau has secured FDA approval to initiate a clinical trial evaluating its Alpha DaRT technology for patients with recurrent glioblastoma, representing a potential new treatment approach for this aggressive brain cancer.
  • Both regulatory milestones highlight ongoing innovation in specialized therapeutic areas, with Theratechnologies focusing on metabolic conditions and Alpha Tau advancing novel radiation technology for difficult-to-treat cancers.

Reunion Neuroscience to Launch REKINDLE Phase 2 Trial for Adjustment Disorder in Cancer Patients Using Psychedelic Therapy

Oncology
• Reunion Neuroscience has unveiled plans for REKINDLE, a Phase 2 clinical trial evaluating RE104, a novel psychedelic therapeutic, for adjustment disorder (AjD) in patients with cancer and other serious medical illnesses.
• AjD affects approximately 500,000 Americans annually following medical diagnoses, with no FDA-approved treatments currently available despite its significant impact on treatment outcomes and quality of life.
• RE104, a proprietary prodrug of 4-OH-DiPT, offers a shorter psychedelic experience (3-4 hours) compared to psilocybin while maintaining similar therapeutic potential, with trial initiation expected mid-2025.

RE104 Safety and Efficacy Study in Postpartum Depression

NCT06342310Active, Not RecruitingPhase 2
Reunion Neuroscience Inc
Posted 6/14/2024

Biotech Leadership Shuffle Continues as Industry Navigates Transformation in Q2 2025

AIOncology
  • Novo Nordisk undergoes significant executive restructuring following the departure of EVP Camilla Sylvest, with rare disease leader Ludovic Helfgott taking over expanded commercial strategy responsibilities.
  • Galapagos faces major leadership transition as CEO Paul Stoffels announces retirement plans while CFO Thad Huston departs, amid the company's ongoing transformation into a cell therapy-focused biotech.
  • Multiple biotechs including Hansa Biopharma, Creyon Bio, and Sutro Biopharma appoint new CEOs as the industry continues strategic realignment efforts.
  • Emerging companies across oncology, rare diseases, and AI-driven drug development strengthen their leadership teams with experienced executives from major pharmaceutical companies.

Chinese Biotech Firms Surge in Global Oncology Licensing Deals, Commanding $30 Billion in 2024

Monoclonal AntibodyOncology
  • Chinese biopharmaceutical companies secured $30 billion in oncology licensing deals in 2024, with monoclonal antibodies and antibody-drug conjugates accounting for 89% of all molecule types.
  • The total deal value from Chinese biopharma was three times that of similar deals licensed from the US, reflecting growing global confidence in China's innovative capabilities.
  • Antibody-drug conjugates dominated the licensing activity, constituting 56% of total deal value at $19 billion, with over half involving bispecific ADCs.
  • Chinese biotech firms completed 33 overseas licensing deals worth $36.2 billion in the first quarter of 2025, up from 28 deals in the same period last year.

PharmaMar Expands Global Reach of Zepzelca with Argentina Approval and Merck Partnership for Japan

Drug ApprovalOncology
  • PharmaMar and partner Adium Pharma have secured conditional marketing approval for Zepzelca (lurbinectedin) in Argentina for treating metastatic small cell lung cancer, extending the drug's availability to 18 territories globally.
  • The company has simultaneously formed an exclusive license agreement with Merck for Zepzelca's development and commercialization in Japan, receiving an initial payment of €22 million with potential for €31 million more in milestone payments.
  • These strategic moves strengthen PharmaMar's position in the oncology market while providing new treatment options for patients with an aggressive form of lung cancer across multiple regions.

Real-World Studies Confirm Bevacizumab Biosimilars Deliver Cost Savings and Equivalent Clinical Outcomes in Metastatic Colorectal Cancer

Monoclonal AntibodyReal World EvidenceOncology
  • A Canadian population-based study found bevacizumab biosimilars Mvasi and Zirabev provided $6,379 CAD in annual cost savings per patient compared to originator Avastin while maintaining equivalent survival outcomes in metastatic colorectal cancer.
  • An Indian real-world analysis of 944 patients demonstrated comparable progression-free survival and overall survival between bevacizumab biosimilars and the reference product in first-line and second-line treatment settings.
  • Both studies support the cost-effectiveness and clinical equivalence of bevacizumab biosimilars, providing evidence for healthcare policy decisions and building confidence among oncologists treating metastatic colorectal cancer.

Study Reveals Chemotherapy Causes Greater Long-Term Physical Health Decline in Breast Cancer Survivors Than Endocrine Therapy

Oncology
  • A new study published in JAMA Network Open found that breast cancer patients treated with chemotherapy experienced significant long-term physical health declines compared to those receiving endocrine therapy alone.
  • Patients who received endocrine therapy maintained physical health profiles similar to women who never had breast cancer, while chemotherapy led to greater declines in mobility, pain levels, and fatigue.
  • Researchers emphasize the need for personalized treatment approaches and suggest incorporating physical therapy into care plans to mitigate long-term effects of chemotherapy.

CytoSite Bio Partners with Lantheus to Develop Granzyme B PET Imaging for Real-Time Immunotherapy Monitoring

Oncology
  • CytoSite Bio has signed a collaboration agreement with Lantheus Holdings for the clinical development and commercialization of a Phase 1-ready granzyme B-targeted PET imaging radiotracer.
  • The investigational imaging technology could enable physicians to measure immunotherapy efficacy within days of first dose rather than waiting months for treatment response assessment.
  • Early studies demonstrate the radiotracer's potential to evaluate immune system activation in immuno-oncology, autoimmune-mediated and inflammatory diseases.
  • Under the agreement terms, CytoSite will lead initial clinical development while Lantheus holds an exclusive option for worldwide development and commercialization rights.

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