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Clinical Trial System Faces Sustainability Crisis as Costs Soar and Workforce Shrinks

AI
  • The clinical trial workforce has declined dramatically, with investigators dropping from 128,303 to 116,948 globally and coordinators falling from 56,036 to 40,472 between 2017-2024.
  • Oncology trial costs have reached unsustainable levels, averaging $30 million for Phase 1 trials and nearly $60 million for Phase 3 studies, with total drug development costs hitting $2.3 billion.
  • Only 5-8% of eligible patients participate in clinical trials, while 60-70% of trial sites fail to meet enrollment targets, creating a bottleneck that threatens future drug development.
  • AI-driven platforms and decentralized trial models offer potential solutions to address recruitment inefficiencies and expand access to underserved rural communities.

Wockhardt Exits US Generics Business to Focus on Novel Antibiotic Drug Discovery

Drug Discovery
  • Wockhardt Ltd has filed for voluntary liquidation of its US subsidiaries Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC under Chapter 7 of the US Bankruptcy Code to exit its loss-making generics business.
  • The company's US generics business incurred nearly $8 million in losses in FY25 and has been unprofitable for several years, prompting the strategic exit.
  • Wockhardt is pivoting to focus on its novel antibiotic drug discovery program, with six candidates in development targeting drug-resistant bacterial infections.
  • The company's lead antibiotic candidate Zaynich has completed global phase 3 trials and has an addressable market potential of $7 billion in the US and Europe.

Daré Bioscience Receives $6 Million Grant Installment for Smart Drug Delivery Platform Development

  • Daré Bioscience received a $6 million non-dilutive grant installment, bringing total funding to $37.8 million of up to $49 million committed for DARE-LARC1 contraceptive development.
  • The DARE-IDDS platform features a programmable, wirelessly controlled device capable of delivering hundreds of individualized doses over months or years without recharging or surgical replacement.
  • Originally developed at MIT by Dr. Robert Langer and Dr. Michael Cima, the platform has broader therapeutic potential beyond contraception, including obesity, diabetes, and neurologic diseases.
  • The company is exploring strategic partnerships to expand the platform's application beyond reproductive health into multibillion-dollar therapeutic markets.

Brenig Therapeutics Appoints New Leadership and Expands Parkinson's Disease Pipeline with NLRP3 Inhibitor Acquisition

  • Brenig Therapeutics appointed David L. Lucchino as CEO and Tien Dam, M.D., as Chief Medical Officer to advance its neurodegenerative disease pipeline.
  • The company acquired BT-409, a brain-penetrant NLRP3 inhibitor from Mwyngil Therapeutics, targeting neuroinflammation in Parkinson's disease and other conditions.
  • Brenig's lead candidate BT-267, a selective LRRK2 inhibitor for Parkinson's disease, continues advancing through clinical development with promising brain penetration and safety profiles.
  • The new NLRP3 inhibitor program will enter pre-IND studies with plans to advance into Phase 1 safety trials.

Intuitive Receives FDA Clearance for Vessel Sealer Curved, First Advanced Energy Instrument Approved for Lymphatic Vessel Transection

  • Intuitive's Vessel Sealer Curved has received FDA clearance as the first advanced energy instrument approved for transection of lymphatic vessels in robotic surgery.
  • The fully wristed bipolar electrosurgical instrument features a slim, curved jaw design that follows natural anatomical contours to improve visibility and control in tight surgical spaces.
  • The device is cleared for sealing, cutting, grasping, and dissecting tissue, including blood vessels up to 7mm in diameter, expanding surgical capabilities for da Vinci systems.
  • This milestone comes as Intuitive marks its 30th year in robotic-assisted technology development, with nearly 17 million da Vinci procedures performed and 90,000 surgeons trained on their systems.

I Peace and Vita Therapeutics Partner to Develop Universal iPS Cells for FSHD Treatment

Gene Editing
  • I Peace and Vita Therapeutics have announced a joint development program to create universal induced pluripotent stem cells (iPSCs) for cell transplantation therapy, with an initial focus on facioscapulohumeral muscular dystrophy (FSHD).
  • The collaboration will produce GMP-grade iPS cells modified with proprietary gene editing technology to create hypoimmune cell lines that have depleted Class I and II HLA genes to prevent transplant rejection.
  • The manufactured master cell bank will be registered in the FDA Drug Master File, with I Peace retaining rights to supply both normal and gene-edited cells for therapeutic applications globally.
  • Universal cells are designed to suppress immune rejection due to HLA incompatibility, allowing transplantation without requiring compatibility matching with the recipient's HLA type.

Wacker Opens New Biotechnology Center in Munich to Accelerate Biopharmaceutical Research

  • Wacker Chemie has opened a new Biotechnology Center in Munich with space for 90 employees and state-of-the-art equipment to concentrate and intensify biotech research activities.
  • The facility focuses on developing bioprocesses for producing proteins and nucleic acids used in novel therapies, including mRNA-based medicines and ingredients for food supplements.
  • The center aims to accelerate commercialization by enabling closer collaboration with customers and business partners, addressing the growing importance of speed in bringing solutions to market.
  • The investment demonstrates Wacker's commitment to biotechnology growth potential even during economically challenging times, strengthening Bavaria's biotechnology expertise.

Australian-First "Seek-and-Destroy" Cancer Therapy Begins Human Trials Targeting CDCP1 Protein

Targeted Therapy
  • A groundbreaking radioactive therapy targeting the CDCP1 protein in cancer cells has begun its first human trial in Australia, with a 69-year-old Brisbane woman becoming the first patient to receive the treatment.
  • The therapy, developed over 24 years by Professor John Hooper, uses an innovative antibody that binds to CDCP1 found in ovarian, bladder, and other common cancers to deliver targeted radiotherapy.
  • Up to 45 patients with ovarian and bladder cancer will participate in the trial, which aims to provide exceptionally accurate imaging of metastasizing cancer and potentially become the gold standard treatment for multiple cancer types.
  • The research represents a collaboration between Mater Research, The University of Queensland, CSIRO, and other institutions, with ovarian cancer having a five-year survival rate of just 49 percent.

Australian Scientists Develop Real-Time Ultrasound Imaging System to Enhance Brain Drug Delivery

  • University of Queensland researchers have developed an innovative device that combines ultrasound and advanced imaging to enable real-time observation of brain cells during drug delivery across the blood-brain barrier.
  • The technology uses sonoporation with ultrasound-activated microbubbles to temporarily open tiny pores in the blood-brain barrier, potentially improving drug uptake from the current 1-2% to more effective levels.
  • The custom-built system, developed over five years, could transform treatments for neurodegenerative diseases like Alzheimer's and Parkinson's by allowing targeted drug delivery to specific brain regions.
  • Beyond neurology, the technology shows promise for sonoporation-based therapies in cardiology and oncology applications.

Solvonis Therapeutics Raises £1M to Accelerate AI-Driven CNS Drug Discovery for Depression and Stimulant Addiction

  • Solvonis Therapeutics secured £1.0 million from three major shareholders to accelerate its AI-supported central nervous system drug discovery programme targeting depression and stimulant use disorders.
  • The funding will enable lead identification and early-stage candidate validation in therapeutic areas with significant unmet needs, including stimulant addiction which currently has no FDA-approved medications.
  • The company's AI-enabled R&D platform integrates proprietary compound libraries and predictive modelling to drive innovation in neuropsychiatric conditions traditionally marked by low investment and slow progress.
  • The global antidepressant market was valued at approximately £15 billion in 2024 and is projected to grow at 7.5% annually through 2034, highlighting the commercial potential of the programme.

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