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Clinical Trial News

First-in-Human Implantation of Medinol's ChampioNIR Drug-Eluting Peripheral Stent

  • Medinol's ChampioNIR drug-eluting peripheral stent was successfully implanted in a first-in-human procedure in Australia, marking a significant advancement in vascular intervention.
  • The stent features a hybrid mechanical design with a metallic component for radial support and a bioresorbable polymeric mesh for flexibility and durability.
  • ChampioNIR's unique drug-elution paradigm allows for therapeutic dosing of large peripheral vessels with a 'limus' drug over an extended period.
  • The CHAMPIONSHIP study will enroll 30 patients across seven sites in Australia and the USA to further evaluate the device's performance.

FDA Issues Warning Letters to Multiple Pharma Companies for GMP Violations

  • CARsgen Therapeutics received a warning for fly infestation and inadequate monitoring during CAR T cell manufacturing.
  • Berkeley Biologics distributed viable bone matrix products without proper donor screening, linked to a tuberculosis outbreak.
  • Zydus Lifesciences faced warnings for cross-contamination due to inadequate cleaning and glass particulate contamination.
  • TJA Health was cited for failing to test raw materials for contaminants and using non-sterile water in drug products.

Blue Shield of California Slashes Humira Biosimilar Price by 75% Through Direct Purchase Model

  • Blue Shield of California announces groundbreaking pricing for Idacio biosimilar at $525 per monthly dose, marking a 75% reduction from Humira's $2100 market price.
  • Through partnership with Fresenius Kabi and Evio Pharmacy Solutions, Blue Shield eliminates traditional PBM markups, offering most patients zero out-of-pocket costs starting January 2025.
  • The initiative challenges conventional PBM pricing models, addressing concerns about Humira's high costs that have resulted in approximately $700 million in increased monthly expenses for healthcare stakeholders.

OnKure Therapeutics Advances Mutant-Specific PI3Kα Inhibitor OKI-219 Following Merger

• OnKure Inc. and Reneo Pharmaceuticals have completed a merger, resulting in OnKure Therapeutics, which now trades on the Nasdaq under the ticker symbol 'OKUR'. • The merger includes a $65 million private placement to support the clinical development of OnKure's drug pipeline, extending the company's cash runway into Q4 2026. • OnKure's lead drug candidate, OKI-219, a selective PI3Kα H1047R inhibitor, is currently in Phase I clinical trials for solid tumors, including breast cancer. • The combined company will focus on exploiting vulnerabilities in PI3K-mutated cancers, with early clinical data for OKI-219 expected later this year.

Bedaquiline Regimens Show Promise in Rifampicin-Resistant Tuberculosis Treatment

  • A study in Brazil shows bedaquiline-containing regimens (BCR) are associated with favorable outcomes in rifampicin-resistant/multidrug-resistant tuberculosis (RR/MDR-TB) treatment.
  • The implementation of BCR was linked to a nearly 10% increase in favorable treatment outcomes compared to previous regimens at the study center.
  • Social factors like education level, alcoholism, and drug use were identified as significant influencers of treatment outcomes.
  • While the study didn't find significant differences in microbiological conversion, it highlights the importance of bedaquiline in managing RR/MDR-TB.

CD7 CAR-T Cell Therapy Shows Promise in Relapsed/Refractory T-ALL

  • A novel CD7 CAR-T cell therapy developed by NUHS has shown significant promise in treating relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).
  • In a study of 17 patients, 16 achieved complete remission within one month, demonstrating the therapy's high efficacy in a heavily pre-treated population.
  • The therapy reprograms patients' own T cells to target CD7-expressing leukemia cells, offering a new curative option without severe side effects.
  • The first patient treated has remained in remission for five years, suggesting long-term efficacy and potential for a durable cure.

Hugel's Letybo Gains Momentum in Global Markets Amidst Legal Challenges

  • Hugel's botulinum toxin, Letybo, received FDA approval, marking a significant entry into the U.S. market and is projected to drive substantial sales growth this year.
  • The company's overseas sales have surged, particularly in Asia-Pacific and Europe, with China experiencing a 62% year-on-year increase in the second quarter.
  • Letybo is now available in 64 countries, with recent expansion into Indonesia, while Hugel navigates a trade secret infringement lawsuit with Medytox.
  • Hugel anticipates significant revenue growth, driven by Letybo's global expansion and strong performance of its HA fillers, despite ongoing legal challenges.

Hansa Biopharma's HNSA-5487 Shows Rapid IgG Reduction and Redosing Potential in Phase 1 Trial

• HNSA-5487 demonstrated a rapid and substantial reduction of IgG levels, exceeding 95% within hours post-treatment, in a Phase 1 trial. • IgG levels returned to the normal range six months after the initial dose, confirming the drug's efficacy and mirroring results of imlifidase. • The trial indicated a favorable safety and tolerability profile for HNSA-5487, with no serious adverse events reported among participants. • HNSA-5487 exhibited lower anti-drug antibody levels and reduced ADA responses compared to imlifidase, suggesting a clear redosing potential.

Wellcome Leap's Quantum for Bio Program Advances Quantum Computing in Healthcare

  • Wellcome Leap's Quantum for Bio program has announced Phase 2 finalists, advancing quantum computing applications in healthcare.
  • Participants receive up to $750,000 to simulate quantum algorithms related to human health applications using classical high-performance computing.
  • Phase 3 offers up to $5 million for demonstrating significant quantum advancements, focusing on practical applications on quantum devices.
  • The program aims to revolutionize areas like drug discovery and genomics by integrating quantum computing with biology and healthcare.

CRISPR-Cas9 Reduces VEGF Levels in Monkeys, Shows Retinal Toxicity at High Doses

  • CRISPR-Cas9 targeting VEGFA delivered via AAV vectors reduces VEGF levels in monkeys, potentially treating choroidal neovascularisation (CNV).
  • Low AAV doses (6 x 1011 vg/eye) led to a 33% reduction in VEGF protein concentrations and decreased CNV severity.
  • High AAV doses (6 x 1012 vg/eye) resulted in significant retinal toxicity, including subfoveal deposits and outer retinal thinning.
  • Retinal damage appears linked to high Cas9 expression or AAV vector dose, not VEGFA gene editing itself, suggesting optimization is needed.

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