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Clinical Trial News

Shilpa Pharma Lifesciences Unit-1 Passes Brazilian ANVISA GMP Inspection with No Critical Findings

  • Shilpa Pharma Lifesciences Limited, Unit-1 successfully completed a GMP inspection by Brazilian regulatory authority ANVISA from June 30-July 4, 2025, with no critical or major observations.
  • The facility received only procedural-related observations and recommendations, to which Shilpa is committed to respond through an appropriate CAPA plan within stipulated timelines.
  • This regulatory milestone follows the facility's recent VAI classification from the USFDA in May 2025, demonstrating consistent compliance across multiple international regulatory jurisdictions.
  • The successful inspection strengthens Shilpa's position as an integrated pharmaceutical group offering CDMO services across oncology APIs, peptides, and differentiated dosage formulations.

Particle Dynamics Acquires EuroAPI UK Spray Drying Facility to Expand Global CDMO Capabilities

  • Particle Dynamics has acquired EuroAPI UK Ltd.'s commercial spray drying facility in Haverhill, UK, strengthening its position as a global contract development and manufacturing organization.
  • The Haverhill facility brings over 20 years of spray drying experience, mature quality management systems, and a strong GMP track record to support both clinical and commercial-scale projects.
  • The acquisition addresses growing industry demand for improved bioavailability, solubility and stability of therapeutic compounds through advanced particle engineering technologies.
  • Particle Dynamics plans to invest in additional capabilities and talent at the site, positioning it as a blueprint for operational excellence in their global network.

Precisio Biotix Achieves First-in-Human Dosing of ClyO Lysin for Multi-Drug Resistant Prosthetic Joint Infection

  • Precisio Biotix Therapeutics successfully administered its first-in-human dose of ClyO (LYSG101), a staph lysin, to a patient with a multi-drug resistant prosthetic joint infection under FDA compassionate care approval.
  • The patient tolerated the treatment without adverse events, marking a significant milestone for lysin-based antimicrobials that bypass traditional antibiotic resistance mechanisms.
  • Drug-resistant infections cause at least 700,000 deaths annually and could reach 10 million by 2050 without decisive action, highlighting the urgent need for novel antimicrobial approaches.
  • Lysins represent a promising new class of antimicrobials that actively hydrolyze bacterial cell walls without causing bacterial resistance, unlike traditional antibiotics.

Serendipity Space Secures Pre-Seed Funding to Advance Microgravity-Based Pharmaceutical Manufacturing

  • Serendipity Space, a space-tech company, has raised pre-seed funding from Campus Fund to develop microgravity-based pharmaceutical manufacturing solutions through its proprietary satellite platform and autonomous crystallization module called 'Alchemy'.
  • The company addresses the pharmaceutical industry's inability to produce high-quality protein and drug crystals on Earth due to gravity-induced defects, with space-based production potentially yielding an average net present value of $1.2 billion per novel drug.
  • Since inception, the team has built and tested multiple functional pharmaceutical modules and demonstrated laboratory-grade crystallization quality through ground-based validation with proteins and small molecules.
  • The funding will enable technical demonstrations to validate core subsystems required for deploying this technology as an end-to-end service for pharmaceutical companies in the growing in-space manufacturing market projected to surpass $10 billion by 2030.

Gene Therapy for Fabry Disease Shows Promise with $3.7 Million Cost Savings in Early-Stage Trial

Rare Disease
  • A small-scale gene therapy study for Fabry disease enabled three of five male patients to discontinue costly enzyme-replacement therapy, generating $3.7 million in savings against $4 million research costs.
  • The experimental treatment uses bone marrow stem cells to deliver replacement copies of faulty genes, with patients maintaining elevated enzyme production five years post-treatment.
  • Researchers plan to expand the study to 25-30 patients including women over two to three years, as the current therapy requires bi-weekly treatments costing $300,000 annually per patient.
  • The gene therapy demonstrated a favorable safety profile with only two minor side effects related to preparatory chemotherapy rather than the gene therapy itself.

Spineway Secures GMED Approval for New ESP Prostheses Production Line, Doubles Manufacturing Capacity

  • Spineway's subsidiary Spine Innovations received GMED approval for a new production line dedicated to LP-ESP and CP-ESP intervertebral disc prostheses, marking a significant strategic milestone for the company.
  • The new production facility in La Rochelle includes a clean room for injection operations and doubles Spineway's manufacturing capacity while securing their supply chain.
  • First LP-ESP prostheses entered production last month with implants from the new line expected to be available by the end of July 2025.
  • The three-year development project strengthens Spineway's position in less invasive spine treatments and reinforces their industrial commitment in France.

Novel Nasal Antibody Treatment Shows Promise for Hay Fever Prevention in Preclinical Study

Monoclonal Antibody
  • Scientists at Kazakh National Agrarian Research University have developed a monoclonal antibody that acts as a "molecular shield" when applied directly to the nose, successfully blocking hay fever symptoms in mice exposed to mugwort pollen.
  • The treatment represents the first time a monoclonal antibody designed to block a specific pollen allergen has been delivered intranasally, showing protection against allergy symptoms in both upper and lower airways.
  • The antibody works by neutralizing allergens on contact at the nasal lining, preventing IgE antibody activation and potentially reducing inflammation through multiple mechanisms.
  • Researchers plan to begin humanization of the antibody and could start clinical trials within two to three years, with market availability potentially five to seven years away.

Everest Medicines Advances AI-Powered mRNA Platform with Cancer Vaccine Breakthroughs

Drug ApprovalCAR-TAI
  • Everest Medicines unveiled major breakthroughs in its proprietary AI-powered mRNA platform during its 2025 R&D Day, showcasing a fully integrated system spanning antigen design to manufacturing.
  • The company's personalized cancer vaccine EVM16 demonstrated robust immunogenicity and mutation-specific T-cell responses in early clinical trials, while off-the-shelf vaccine EVM14 received FDA IND clearance.
  • Everest's innovative in vivo CAR-T program achieved high T-cell transduction efficiency and effective B-cell clearance in preclinical studies, offering a scalable alternative to conventional CAR-T therapies.
  • The company is pursuing global partnerships with top 20 pharmaceutical companies to accelerate international deployment of its clinically validated mRNA assets.

AB Science's Masitinib Receives FDA and EMA Authorization for Confirmatory Phase 3 Trial in Metastatic Castrate-Resistant Prostate Cancer

Oncology
  • AB Science announced that both FDA and EMA have authorized a confirmatory phase 3 trial of masitinib in combination with docetaxel for metastatic castrate-resistant prostate cancer, using biomarker-driven patient selection.
  • The 600-patient study will target patients with less advanced metastatic disease based on baseline alkaline phosphatase levels, potentially establishing the first targeted combination with docetaxel in nearly two decades.
  • Previous phase 3 results demonstrated masitinib plus docetaxel achieved a 21% reduction in progression risk with a hazard ratio of 0.79 in patients with alkaline phosphatase ≤250 IU/L.
  • The treatment addresses a significant unmet medical need, as there is currently no drug registered for combination with docetaxel in mCRPC patients despite docetaxel's approval almost 20 years ago.

Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

NCT02588677CompletedPhase 2
AB Science
Posted 4/1/2013

A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)

NCT06968741RecruitingNot Applicable
UroMems SAS
Posted 5/1/2025

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

NCT04640623Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 12/18/2020

Shimadzu Receives FDA Clearance for High-Resolution PositView PET System for Alzheimer's Diagnosis

  • Shimadzu Corporation received FDA premarketing notification for its PositView PET system specialized for head and breast examinations, launching in the US on June 30, 2025.
  • The system features a 28 cm detector ring diameter, significantly smaller than standard 80 cm whole-body PET systems, enabling twice the resolution for high-definition imaging.
  • The device targets amyloid-β and tau protein imaging in the brain for Alzheimer's disease diagnosis and therapeutic decision-making.
  • The technology addresses growing demand for amyloid PET examinations as Alzheimer's cases increase and tau protein-targeted therapies advance.

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