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Clinical Trial News

Over-the-Counter Birth Control Pill Dramatically Increases Contraceptive Access Among Underserved Populations

Drug Approval
  • A nationwide OHSU study of 986 people across 49 states found a 31.8 percentage point increase in contraceptive use among those who previously used no birth control method after accessing over-the-counter pills.
  • The over-the-counter birth control pill particularly benefited racial and ethnic minorities, adolescents, uninsured individuals, and Medicaid recipients who faced the greatest barriers to reproductive healthcare access.
  • Research published in JAMA Network Open demonstrates that removing prescription requirements for oral contraceptives effectively expands access for underserved populations, especially in rural areas where healthcare access is limited.
  • The study provides clear evidence that the FDA's 2023 approval of over-the-counter birth control pills is addressing critical gaps in contraceptive access during a time of increasing reproductive health restrictions.

FDA Issues Draft Guidance Prioritizing Overall Survival as Primary Endpoint for Cancer Drug Approvals

Drug ApprovalOncology
  • The FDA has published new draft guidance emphasizing overall survival as the preferred primary endpoint for cancer drug trials, marking a shift toward prioritizing long-term patient outcomes in the approval process.
  • The guidance comes less than two weeks after the return of CBER Head Vinay Prasad, who has previously advocated for prioritizing overall survival over surrogate endpoints in oncology drug evaluations.
  • While the new requirements may make accelerated approval more challenging, the FDA still permits this pathway for drugs with significant uncertainty in OS findings but sufficient evidence of efficacy via intermediate clinical endpoints.
  • The guidance recommends limiting crossover study designs to avoid confounding overall survival analysis, permitting them only in diseases with no or very limited therapeutic options.

WuXi Biologics Receives EMA Approval for Ireland Manufacturing Facility, Advancing Global Dual Sourcing Strategy

  • WuXi Biologics' Dundalk, Ireland facility received European Medicines Agency (EMA) approval for commercial manufacturing of an innovative biologic, marking the first commercial launch from the Ireland site.
  • The approval reinforces WuXi Biologics' Global Dual Sourcing Strategy, which deploys multiple qualified manufacturing sites worldwide for the same product family to enhance regional patient access.
  • The Dundalk facility features advanced manufacturing capabilities including 48,000-liter fed-batch capacity and achieved a 100% success rate across multiple large-scale Process Performance Qualification runs.
  • WuXi Biologics maintains a 100% success rate in global regulatory inspections with 42 regulatory inspections successfully passed and 97 license approvals from agencies worldwide as of end 2024.

First-in-Class Monoclonal Antibody Shows Promise Against Sepsis-Induced Immune Dysregulation

Monoclonal Antibody
  • Researchers at University of Virginia and University of Michigan developed a humanized monoclonal antibody targeting citrullinated histone H3 to combat sepsis, which kills approximately 11 million people worldwide annually.
  • Initial mouse studies demonstrate the antibody can prevent cytokine storms and restore macrophage function without unwanted immune suppression, showing potential for treating ARDS and autoimmune disorders.
  • The team received $800,000 from Virginia Catalyst to launch clinical trials, with the antibody engineered for clinical application alongside a diagnostic platform called PEdELISA.
  • The research identified molecular mechanisms in macrophages that drive sepsis-related inflammatory feedback loops, which the antibody successfully interrupts.

University of Houston Develops First Spleen-Targeted Nanoparticle System for Lupus Treatment

Targeted Therapy
  • University of Houston biomedical engineer Tianfu Wu has received a $1 million Department of Defense Impact Award to develop a novel spleen-specific drug delivery system for lupus treatment.
  • The innovative system uses mannose-modified lipid nanoparticles to directly target immune cells in the spleen, including B cells, plasmacytoid dendritic cells, and macrophages that drive lupus pathogenesis.
  • This approach represents the first instance of a spleen-specific targeting system designed for lupus models, potentially offering more precise treatment with reduced systemic side effects.
  • The technology aims to modulate immune responses rather than employing broad immunosuppression, addressing current therapeutic limitations in lupus management.

Novel Monoclonal Antibody Stapokibart Demonstrates Significant Efficacy in Severe Chronic Rhinosinusitis with Nasal Polyps

Monoclonal Antibody
  • A 24-week double-blind, placebo-controlled trial published in JAMA showed stapokibart, a novel monoclonal antibody, significantly reduced nasal polyp size and symptom severity when combined with daily intranasal corticosteroids.
  • Stapokibart targets the interleukin-5 receptor alpha subunit (IL-5Rα) on eosinophils and basophils, effectively curtailing eosinophil survival and tissue infiltration to attenuate chronic inflammation responsible for polyp proliferation.
  • Patients treated with stapokibart reported notable improvements in nasal obstruction, rhinorrhea, facial pressure, and olfactory dysfunction, with clinically meaningful declines in SNOT-22 scores.
  • The therapy demonstrated a favorable safety profile with mild and transient side effects including nasopharyngitis and headache, with no serious adverse events or immunogenicity concerns reported.

Genentech Initiates First Patent Litigation Against Pertuzumab Biosimilar HLX11

Monoclonal AntibodyFDA Approval
  • Genentech filed the first BPCIA litigation against Shanghai Henlius Biotech and Organon on August 14, 2025, alleging infringement of 24 patents by their proposed pertuzumab biosimilar HLX11.
  • The lawsuit represents the first patent challenge for a pertuzumab biosimilar, with Henlius and Organon's aBLA being the only publicly announced application currently pending with the FDA.
  • Genentech asserted 24 of the 47 patents it had listed during the BPCIA patent dance, including 10 method of treatment patents and 10 manufacturing patents.
  • The litigation seeks injunctive relief to prevent commercialization of HLX11 and damages for alleged patent infringement under the BPCIA framework.

Propanc Biopharma Surges 150% Following Nasdaq Uplisting and FDA Orphan Drug Designations

  • Propanc Biopharma's shares soared 150% following its successful uplisting from OTC Pink Tier to Nasdaq on August 15, 2025, trading under ticker PPCB.
  • The biotech company received FDA Orphan Drug Designations, a regulatory milestone that enhances credibility and improves visibility among institutional investors.
  • Trading volumes exploded to 5 million shares compared to the usual daily average of 19,000, driven by a $4 million underwritten public offering priced at $4.00 per share.
  • The company faces financial challenges with $53.1 million in operating expenses against minimal revenues, though it maintains a strong current ratio of 2.2 and low debt-to-equity ratio of 0.04.

Qihan Biotech Receives FDA Clearance for QT-019B, First Universal Dual-Target CAR-T Therapy for Refractory Lupus

CAR-TGene Editing
  • The FDA has cleared Qihan Biotech's IND application for QT-019B, enabling a Phase 1/2 clinical trial for refractory systemic lupus erythematosus in the United States.
  • QT-019B is an off-the-shelf allogeneic CAR-T therapy targeting both CD19 and BCMA antigens, engineered with gene editing to reduce immune rejection and enhance persistence.
  • The therapy has shown promising results in investigator-initiated clinical studies in China against multiple refractory autoimmune diseases, including systemic lupus erythematosus.
  • Qihan Biotech is developing next-generation CAR-T therapies that will not require lymphodepletion, potentially transforming treatment paradigms for autoimmune diseases.

LivaNova Launches Essenz Perfusion System in China Following NMPA Approval

  • LivaNova PLC has launched its Essenz Perfusion System in China after receiving regulatory approval from the National Medical Products Administration, targeting the world's second-largest heart-lung machine market.
  • The next-generation cardiopulmonary platform has supported over 100,000 patients globally since its 2023 launch and offers real-time monitoring with patient-tailored perfusion capabilities.
  • China represents a significant growth opportunity with 330 million individuals affected by cardiovascular disease and over 700 hospitals equipped for cardiac surgery.
  • The system addresses the projected 185,000 adult and 23,500 pediatric extracorporeal circulation procedures expected in China for 2025.

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