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Clinical Trial News

CUHK Develops Magnetic Microcatheter for Precise Treatment of Acute Ischemic Stroke

  • Researchers at The Chinese University of Hong Kong have developed the first sub-millimeter Magnetically Actuated Soft Rotatable-tipped Microcatheter (MSRM) for treating acute ischemic strokes.
  • The device features a soft, rotatable tip guided wirelessly by external magnetic fields, enabling precise navigation through complex blood vessels while delivering clot-dissolving drugs and mechanically breaking down clots.
  • Testing in human placenta blood vessels showed the MSRM caused minimal cell damage compared to traditional guidewires, with its low rotation speed of 2-8 Hz reducing trauma to delicate brain vessels.
  • The all-in-one design eliminates the need for tool exchanges during procedures, potentially offering new treatment options for distal-to-medium vessel occlusions that account for 25-40% of acute ischemic strokes.

Roche Launches Clinical Trial for Trontinemab to Prevent Alzheimer's Disease

  • Roche announced plans to test Trontinemab, an experimental drug designed to delay or prevent Alzheimer's disease symptoms in at-risk individuals.
  • The drug features enhanced blood-brain barrier transport technology to improve brain delivery compared to existing treatments.
  • This trial represents part of Roche's expanding Alzheimer's development program amid recent competitive advances by Eli Lilly's Kisunla.
  • Current approved Alzheimer's treatments target amyloid beta plaques but carry risks of brain swelling and bleeding with high costs.

Colorcon Opens State-of-the-Art Film Coating Manufacturing Facility in Malaysia to Strengthen Asia-Pacific Supply Chain

  • Colorcon has inaugurated a new 200,000 square-foot film coating manufacturing facility in Johor, Malaysia, employing 30 people initially and serving as the production hub for the Asia-Pacific region.
  • The state-of-the-art facility features cutting-edge technology and energy-efficient systems, reinforcing Colorcon's commitment to industry innovation, quality, and environmental stewardship.
  • This strategic investment strengthens Colorcon's global supply network for film coatings and positions the company to better anticipate market growth and meet evolving customer demands in the rapidly growing Asia-Pacific pharmaceutical market.
  • The facility represents one of several development projects in Colorcon's pipeline to support their mission of being "everywhere our customers need us to be" while contributing to Malaysia's emergence as a high-value pharmaceutical manufacturing hub.

Granules India CEO Dr. K V Sitaram Rao Announces Resignation Effective July 2025

Leadership Change
  • Dr. Kandiraju Venkata Sitaram Rao has resigned from his position as Joint Managing Director and CEO of Granules India Limited, effective July 31, 2025.
  • The pharmaceutical executive brings over 29 years of experience in manufacturing, R&D, and business operations to his departure from the Indian generic drug manufacturer.
  • Granules India has acknowledged the resignation and is implementing measures to ensure a seamless leadership transition over the coming weeks.
  • Dr. Rao previously held senior leadership positions at PI Industries, Dr. Reddy's Laboratories, Jubilant Life Sciences, and Gujarat Heavy Chemicals Ltd.

Rigicon Initiates AUSOME Study for Artificial Urinary Sphincter FDA Approval

FDA Approval
  • Rigicon has begun patient enrollment in the AUSOME Study, a pivotal clinical investigation designed to support FDA Premarket Approval for its artificial urinary sphincter technology.
  • The first two patients were enrolled in the UK under the leadership of Dr. Rowland Rees, with the study evaluating safety, effectiveness, and patient-reported outcomes.
  • The company plans to expand enrollment across global urology centers and is developing additional product lines including electronic artificial urinary sphincter and penile prostheses.
  • Rigicon's device offers advancements in patient comfort, usability, and durability compared to existing artificial urinary sphincter solutions on the market.

Fecal Microbiota Transplantation Shows Safety and Tolerability in Six-Month Parkinson's Disease Pilot Study

  • A pilot study of 12 Parkinson's disease patients demonstrated that six-month fecal microbiota transplantation (FMT) therapy is safe and well-tolerated, with 92% completing the full treatment course.
  • Patients showed significant improvement in quality of life scores at two months, with trends toward improvement in non-motor symptoms, though these benefits were not sustained at six months.
  • The study represents the first evaluation of extended FMT therapy in Parkinson's disease, establishing a foundation for larger randomized controlled trials to assess therapeutic efficacy.

Bangladesh Pharmaceutical Companies Risk Losing Royalty-Free Access to 15 Biologic Drugs Due to Regulatory Delays

  • Bangladesh's pharmaceutical companies face losing the opportunity to produce at least 15 costly biologic drugs royalty-free due to regulatory hurdles that have stalled over 600 medicine registration applications for more than a year.
  • The Drug Control Committee, responsible for final approval of new medicines, has not convened for two years, creating a critical bottleneck as Bangladesh approaches its November 2026 transition from Least Developed Country status.
  • Local production of biologic medicines has dramatically reduced costs, with Adalimumab prices dropping from Tk 1.65-3.6 lakh to Tk 15,000 and Filgrastim from Tk 85,000-95,000 to Tk 7,000-8,000 per syringe.
  • Industry experts warn that missing the patent waiver window could increase drug prices by 25-30 percent, potentially pushing essential medicines out of reach for many patients.

Applied DNA Sciences Secures $600,000 Follow-On Order for Cancer Diagnostic Component

  • Applied DNA Sciences received a seventh follow-on order valued at more than $600,000 for multi-gram quantities of LineaDNA from a global IVD manufacturer.
  • The LineaDNA will be used as a functional component in a cancer diagnostic test, with deliveries scheduled across four quarterly shipments beginning in Q2 fiscal 2026.
  • The proprietary LineaDNA platform produces high-fidelity DNA free of adventitious sequences using cell-free production methods, offering advantages over conventional plasmid-based approaches.
  • This order represents continued commercial validation of Applied DNA's PCR-based synthetic DNA manufacturing technology in the diagnostics market.

PTAB Director Denies Amgen's IPR Challenges Against Bristol Myers Squibb's Opdivo Patents Based on Settled Expectations

Monoclonal Antibody
  • The USPTO Acting Director discretionarily denied two of Amgen's inter partes review petitions challenging Bristol Myers Squibb's Opdivo and Yervoy patents, citing "strong settled expectations" due to the patents being in force for six and seven years respectively.
  • The decision marks a significant shift in PTAB policy, as settled expectations had not previously been cited as grounds for discretionary denial in biosimilar-related IPRs, potentially making it more difficult for biosimilar manufacturers to challenge older patents.
  • Amgen is developing ABP 206, a biosimilar version of Opdivo, which generated $5.35 billion in U.S. sales for Bristol Myers Squibb in 2024.
  • A third IPR petition challenging a newer 2022 patent was referred to the Board for merit review, suggesting that patent age may be a critical factor in future discretionary denial decisions.

CytoDyn Files $100M Mixed Shelf Offering to Advance Leronlimab Through Phase III Trials

Oncology
  • CytoDyn Inc. filed a $100 million mixed securities shelf offering under SEC Form S-3 to provide capital flexibility for advancing its lead drug candidate leronlimab through Phase III trials.
  • Leronlimab, a CCR5 antagonist, is progressing through Phase II trials for oncology indications including triple-negative breast cancer and non-alcoholic steatohepatitis, with results expected at the 2025 ESMO meeting.
  • The strategic filing allows the company to issue various securities without repeated regulatory approvals, potentially minimizing dilution while funding critical clinical milestones.
  • The drug targets combined HIV and oncology markets estimated at over $150 billion, positioning CytoDyn for potential partnerships or licensing deals with larger pharmaceutical companies.

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