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Clinical Trial News

MedHub-AI Receives PMDA Approval for AI-Powered Coronary Assessment Technology in Japan

AI
  • MedHub-AI's AutocathFFR® becomes the first fully automated AI-powered software to receive PMDA approval in Japan for calculating Fractional Flow Reserve values directly from X-ray angiograms without invasive procedures.
  • The approval is supported by a pivotal study of 504 vessels demonstrating 93.7% diagnostic accuracy, 90.2% sensitivity, and 94.9% specificity compared to traditional invasive FFR measurements.
  • The company has partnered with Terumo Corporation for Japanese market distribution and expects FDA approval in the near future to accelerate global expansion.
  • AutocathFFR® delivers FFR results in just 37 seconds, eliminating the need for guidewires and vasodilatory drugs while providing operator-independent decision support for cardiologists.

TGS and Viridien Launch Laconia Phase III Ocean Bottom Node Survey in Gulf of America

  • TGS and Viridien have commenced Laconia Phase III, a large-scale ocean bottom node survey spanning approximately 150 OCS blocks in the Gulf of America's central Keathley Canyon area.
  • The project utilizes advanced seismic technologies including TGS' ZXPLR™ nodes and Sercel's Tuned Pulse Source to deliver ultra-long offset data with enhanced low-frequency imaging capabilities.
  • The survey targets the increasingly attractive Paleogene play following recent industry success with 20k technologies, with initial products scheduled for delivery in Q1 2026.
  • Viridien's proprietary Elastic Full-Waveform Inversion and Reverse Time Migration imaging technologies will process the data to provide best-in-class seismic solutions for exploration and development activities.

HotSpot Therapeutics to Present IRF5 Small Molecule Inhibitor Data at FOCIS 2025

  • HotSpot Therapeutics will present preclinical data on selective small molecule IRF5 inhibitors at the 25th Annual FOCIS meeting in Boston on June 25, 2025.
  • The company's Smart Allostery platform uses computational approaches and AI-driven data mining to identify "natural hotspots" on proteins for drug targeting.
  • HotSpot is developing a pipeline of novel allosteric therapies for autoimmune diseases and cancer using their proprietary hotspot-targeting approach.
  • The IRF5 program represents part of the company's broader strategy to create oral, small molecule allosteric drugs with novel pharmacology.

Simcere Zaiming Initiates US Phase 1 Trial of Trispecific Antibody SIM0500 for Relapsed/Refractory Multiple Myeloma

Oncology
  • Simcere Zaiming has dosed the first US patient in a Phase 1 trial of SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3 for relapsed/refractory multiple myeloma treatment.
  • The investigational therapy combines dual tumor antigen targeting with T-cell engagement and has received FDA Fast Track designation, showing promising preclinical cytotoxicity against multiple myeloma cells.
  • SIM0500 is being developed in partnership with AbbVie, which holds an option to license the compound following preliminary data suggesting good safety profile and encouraging efficacy results.

Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma

NCT06375044RecruitingPhase 1
Jiangsu Simcere Pharmaceutical Co., Ltd.
Posted 5/24/2024

Saptalis Pharmaceuticals Launches Fluoxetine Oral Solution for Multiple Mental Health Conditions

  • Saptalis Pharmaceuticals has commercially launched Fluoxetine Oral Solution, USP 20 mg/5 mL, a prescription SSRI designed to treat major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, and panic disorder.
  • The oral formulation specifically addresses treatment challenges for patients who have difficulty swallowing solid dosage forms, supporting more flexible and individualized treatment approaches.
  • The launch expands Saptalis' specialty pharmaceutical portfolio and reflects the company's commitment to providing accessible medications that meet evolving patient and healthcare provider needs.

Precision Medicine Oncology Pharmacists Emerge as Critical Players in Personalized Cancer Care

Precision MedicineTargeted Therapy
  • Precision medicine oncology pharmacists have become essential members of multidisciplinary cancer care teams, contributing to targeted therapy selection, molecular tumor board discussions, and patient access to novel drug combinations.
  • These specialized pharmacists address significant barriers to precision oncology implementation, including complex medication access pathways, insurance restrictions, and the need for comprehensive patient education on oral anticancer medications.
  • Despite the expanding role of pharmacists in precision medicine, up to 70% remain unaware of institutional precision medicine initiatives, highlighting the need for increased training and institutional support to fully realize their potential in personalized cancer care.

Insulet Presents Real-World Evidence of Omnipod 5 Benefits in Type 2 Diabetes at ADA 2025

Real World EvidenceFDA Approval
  • Insulet shared real-world glycemic outcomes data from over 23,000 people with type 2 diabetes using the Omnipod 5 automated insulin delivery system in the United States.
  • New analysis from the SECURE-T2D pivotal trial demonstrated that Omnipod 5 significantly reduced diabetes distress in adults with type 2 diabetes over 13 weeks.
  • More than 30% of new patient starts in Q1 2025 were people with type 2 diabetes, reflecting growing adoption since FDA expanded indication in August 2024.
  • The company is advancing development of next-generation hybrid closed-loop and fully closed-loop systems, with plans to begin second EVOLUTION studies for type 2 diabetes in the second half of 2025.

BioNTech Shuts Down Maryland Cell Therapy Manufacturing Following CAR-T Trial Failure

CAR-TOncology
  • BioNTech will lay off 63 employees and wind down cell therapy manufacturing at its Gaithersburg, Maryland facility by the end of 2025 following disappointing Phase 1 trial results.
  • The company discontinued development of its CAR-T candidate BNT211 targeting CLDN6 in testicular cancer and germ cell tumors due to insufficient efficacy data.
  • Despite the setback, BioNTech continues studying BNT211 in other CLDN6-expressing cancers including ovarian, sarcoma, endometrial, and gastric cancers.
  • The facility closure is part of broader oncology pipeline restructuring as BioNTech realigns resources and reduces global workforce by up to 1,350 jobs by 2027.

FDA Issues Critical Safety Warning for Scopolamine Patch Following 13 Global Hyperthermia Cases

  • The FDA has identified 13 worldwide cases of hyperthermia associated with scopolamine patches, including two deaths and four hospitalizations, with most cases occurring in vulnerable populations under 17 or over 60 years old.
  • Three patients experienced dangerous body temperatures exceeding 105°F, with symptoms typically appearing within 72 hours of initial patch application and often accompanied by other anticholinergic effects.
  • The agency now requires updated labeling warnings and urges clinicians to exercise particular caution when prescribing to high-risk groups or during hot weather conditions.
  • Most cases involved off-label pediatric use for managing drooling and secretions in neurological conditions, despite the patch lacking FDA approval for children.

Kindeva Partners with Rocket Science Health to Advance Novel Intranasal CNS Drug Delivery Platform

  • Kindeva and Rocket Science Health have formed a non-exclusive partnership to develop the RSH Olfactory Delivery Device, a dual nostril intranasal platform that precisely targets the olfactory clefts for direct CNS drug delivery.
  • The innovative device overcomes complex nasal anatomy challenges by ejecting a laminar stream rather than conventional plume sprays, with proprietary dispensing tips extending past the nasal valve for optimal drug deposition.
  • The technology is designed with human factors considerations for accessibility and accurate dosing, particularly benefiting cognitively and physically impaired patients requiring self-administration.
  • Kindeva's CDMO expertise and regulatory pathway knowledge will support RSH's journey toward FDA approval and eventual commercial distribution of this breakthrough intranasal delivery innovation.

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