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Clinical Trial News

BD Libertas Wearable Injector Enters First Pharma-Sponsored Clinical Trial for Complex Biologics Delivery

  • BD announces the first pharma-sponsored combination product clinical trial using its BD Libertas™ Wearable Injector for subcutaneous delivery of complex biologics.
  • The selection follows successful outcomes from more than 50 BD-conducted pre-clinical and clinical studies, with 100% of participants stating they would likely use the device if prescribed.
  • The wearable injector supports high-viscosity biologics up to 50 centipoise and offers 2-10 mL configurations, potentially enabling conversion from hospital-based infusions to home-based self-injection.
  • The biologics market is projected to exceed $670 billion by 2030, positioning this drug delivery innovation as a significant advancement for patient-centric biologic therapy administration.

Bio Usawa and ServareGMP Partner to Establish Monoclonal Antibody Manufacturing in Africa

Monoclonal Antibody
  • Bio Usawa Biotechnology and ServareGMP announced a strategic partnership to build advanced monoclonal antibody manufacturing capabilities in Africa, addressing critical healthcare access gaps in low- and middle-income countries.
  • The collaboration focuses on four core pillars: local biomanufacturing infrastructure, workforce development, process innovation for cost reduction, and emergency response capabilities for pandemics and health crises.
  • The partnership aims to fundamentally restructure how biotherapeutics are developed, produced, and delivered in LMICs by investing in local talent, infrastructure, and innovation to ensure equitable access to life-saving therapies.

Dispatch Bio Emerges with $216M to Develop Universal Solid Tumor Immunotherapy

CAR-T
  • Dispatch Bio, a new biotech company formed through collaboration between Arch Venture Partners and the Parker Institute for Cancer Immunotherapy, has raised $216 million to develop a universal solid tumor treatment approach.
  • The company's lead therapy combines gene therapy, immunotherapy, and cell therapy by using engineered viruses to tag cancer cells with a synthetic "flare" antigen that CAR-T cells can then target and destroy.
  • Founded by renowned researchers including University of Pennsylvania's Carl June and Stanford's Chris Garcia, the approach aims to overcome current limitations of checkpoint inhibitors and CAR-T therapies in treating solid tumors.
  • The therapy is expected to enter clinical testing next year and could potentially address the challenge that many "cold" tumors pose to existing immunotherapies.

Ghana FDA and Company Deny COA-72 HIV Clinical Trial Claims Following Media Misinformation

  • Ghana's Food and Drugs Authority officially denied approving any clinical trials for COA-72 as an anti-HIV drug, calling media reports false and dangerous to public health.
  • COA Research and Manufacturing Limited Company clarified that COA-72 has not entered FDA-approved clinical trials, despite showing promising results in pre-clinical studies including reduced HIV viral loads.
  • The company applied for clinical trial approval in 2019 but has not yet fulfilled all FDA requirements, while estimating the product could contribute $76.8 billion annually to Ghana's economy if validated.

A.forall Launches Direct Commercialization of Sodium Acetate Injection to Address U.S. Drug Shortage

  • A.forall announced the direct commercialization and launch of Sodium Acetate Injection 2mEq/mL through its U.S. subsidiary Milla Pharmaceuticals Inc.
  • The injectable solution is available in 20mL, 50mL, and 100mL vials and is indicated for preventing or correcting hyponatremia in patients with restricted oral intake.
  • The company has been supplying Sodium Acetate in the U.S. for four years during ongoing shortages and now addresses the shortage directly through its own commercial organization.
  • This milestone represents A.forall's continued investment in serving the U.S. marketplace, particularly for products experiencing shortages.

CSL Behring's Australian Plasma Facility Wins Global Manufacturing Excellence Award for Advanced Automation

  • CSL Behring's $900 million plasma fractionation facility in Broadmeadows, Victoria, has been named 2025 Facility of the Year in the Pharma 4.0 category by the International Society for Pharmaceutical Engineering.
  • The facility represents the world's largest plasma fractionation facility of its kind, processing over 10 million liters of plasma annually and increasing CSL Behring's local capacity ninefold.
  • The award recognizes the facility's full-scale integration of robotics, automation technologies, and digital twin technology that enhances safety, reduces waste, and improves operational efficiency.
  • The facility produces plasma-derived therapies for treating immunodeficiencies, neurological disorders, shock, burns, and supports transplant, surgical, and cancer patients globally.

Biocon Biologics Expands Nepexto Biosimilar to Australian Market for Autoimmune Disease Treatment

  • Biocon Biologics has launched Nepexto, a biosimilar to Enbrel (etanercept), in Australia through partnership with Generic Health to expand patient access.
  • Nepexto targets multiple autoimmune diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis.
  • The biosimilar has demonstrated broad adoption across Europe since receiving EU marketing authorization in 2020.
  • This launch represents part of Biocon Biologics' strategic global expansion following their 2022 acquisition and vertical integration of the biosimilars business.

Syntellix Secures NMPA Approval for Bioabsorbable Metallic Implants in China, Unlocking 1.4 Billion Patient Market

  • Syntellix AG received product approval from China's NMPA for its MAGNEZIX® bioabsorbable metallic implants, marking the company's most significant regulatory milestone and opening access to over 1.4 billion potential patients.
  • The Singapore-based manufacturing subsidiary now holds approvals in countries representing more than 5.5 billion inhabitants across 73 countries and regions on five continents, with China representing the largest single market opportunity.
  • The company's bioabsorbable metallic orthopedic implants have been documented in over 50 medical publications as "advantageous" and "clinically superior" to conventional titanium implants, with tens of thousands of successful surgeries completed globally.
  • Syntellix plans to leverage its Singapore production facility as an Asia-wide sales hub and is preparing for an IPO on the Singapore Exchange following this strategic market entry.

Kidney Cancer Research Consortium Advances Novel Combination Therapies Through Multi-Institutional Collaboration

  • The Kidney Cancer Research Consortium, a DoD-funded program led by Dr. Eric Jonasch, includes 7 institutions collaborating on hypothesis-testing clinical trials for novel kidney cancer therapeutic strategies.
  • The consortium has developed a portfolio of 10 clinical trials that combine established immune-modulating agents like nivolumab plus ipilimumab with novel therapeutic agents including LAG3 inhibitors and lutetium-177 girentuximab.
  • Researchers can conduct more mechanistic and scientifically driven investigations while collecting correlative samples including circulating tumor DNA, tissue samples, and quality of life data to acquire more information from fewer patients in less time.

Avalyn Pharma Raises $100M to Advance Inhaled Pulmonary Fibrosis Therapies

  • Avalyn Pharma secured $100 million in an oversubscribed Series D financing round to advance inhaled formulations of existing pulmonary fibrosis drugs pirfenidone and nintedanib.
  • The company is developing AP01 (inhaled pirfenidone) for Phase IIb trials and AP02 (inhaled nintedanib) for Phase II studies, aiming to reduce systemic side effects while maintaining efficacy.
  • Only 30% of the 300,000 U.S. pulmonary fibrosis patients take current oral medications due to severe gastrointestinal side effects including diarrhea, indigestion, and vomiting.
  • The inhaled delivery approach targets the lungs directly at lower doses, potentially improving tolerability for a disease with a median survival of 3-5 years.

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