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Clinical Trial News

Philips Receives FDA Clearance for AI-Powered MRI Software That Accelerates Scans by 3x

AI
  • Philips has received FDA 510(k) clearance for SmartSpeed Precise, an AI-powered MRI reconstruction tool that can scan up to three times faster while producing images up to 80% sharper than earlier methods.
  • The software integrates Philips' Compressed SENSE acceleration engine with dual AI models for denoising and image sharpening, offering a single-click workflow to address staff shortages and patient backlogs.
  • Clinical testing at University Hospital Bonn demonstrated breast MRI acquisition times reduced by up to 50% with improved image quality compared to previous protocols.
  • The technology is now available for all Philips 1.5-tesla and 3-tesla MRI systems, including existing installed base systems as an upgrade option.

BXCL701 Plus Pembrolizumab Shows Early Promise in Second-Line Pancreatic Cancer Treatment

  • The EXPEL PANC Phase II trial evaluating BXCL701 combined with pembrolizumab in second-line advanced pancreatic ductal adenocarcinoma achieved a 39% disease control rate and 17% overall response rate in 18 evaluable patients.
  • Three patients experienced durable stable disease lasting 6 months or longer, with median progression-free survival reaching 2.3 months and median overall survival not yet reached.
  • The combination demonstrated the ability to shrink tumors in both lymph nodes and liver metastases in microsatellite-stable pancreatic cancer, historically resistant to immunotherapy.
  • No new safety signals were identified, with adverse events consistent with known profiles of both agents, supporting the tolerability of this novel combination approach.

BXCL701 and Pembrolizumab in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

NCT05558982RecruitingPhase 2
Georgetown University
Posted 8/16/2023

GSK's Gepotidacin Receives FDA Priority Review for Gonorrhea Treatment

  • GSK's gepotidacin has been granted FDA Priority Review designation for the treatment of gonorrhea, representing a significant regulatory milestone for this novel antibiotic.
  • The Priority Review status accelerates the FDA's evaluation timeline, potentially bringing this new treatment option to patients with gonorrhea infections more rapidly.
  • This development addresses a critical unmet medical need in treating gonorrhea, particularly as antibiotic resistance continues to challenge current treatment options.

Novel Royalty-Based Investment Fund Proposes New Model for ALS Drug Development

  • Researchers from MIT, Massachusetts General Hospital, and Boston University propose a novel "Fund of Adaptive Royalties" (FAR) that finances half the cost of adaptive platform trials in exchange for future drug royalties.
  • The innovative financing model generated an expected return of 28% with a 22% probability of total loss in simulations based on HEALEY ALS Platform Trial data.
  • Adaptive platform trials allow multiple ALS drug candidates to be tested simultaneously under a single protocol, offering lower costs and shorter durations compared to traditional clinical trials.
  • The approach aims to address the funding bottleneck that has slowed ALS therapy development by attracting risk-tolerant investors like hedge funds and philanthropists.

Regener-Eyes Receives FDA Closure of Voluntary Recall, Returns to Full Operations with Enhanced Safety Features

FDA Approval
  • The U.S. Food and Drug Administration has officially closed Regener-Eyes' voluntary product recall, marking full regulatory resolution and return to normal operations for the dry eye treatment company.
  • The company proactively initiated the recall out of abundance of caution and introduced an enhanced bottle design featuring advanced backflow prevention technology to protect against microbial contamination.
  • Regener-Eyes is now in full production and distribution of its upgraded bottle design while maintaining confidence in the product's continued safety and efficacy for treating dry eyes.

Invivyd Forms SPEAR Study Group to Investigate Monoclonal Antibody Therapy for Long COVID

Monoclonal Antibody
  • Invivyd has established the SPEAR Study Group with leading researchers to investigate monoclonal antibody therapy for Long COVID and Post-Vaccination Syndrome, following anecdotal reports of symptom relief with PEMGARDA.
  • The study group will conduct rigorous clinical trials to evaluate the safety and efficacy of anti-SARS-CoV-2 spike protein monoclonal antibodies in patients with persistent viral reservoirs or circulating spike protein.
  • Long COVID affects approximately 5% or more of Americans with no approved treatments currently available, representing a significant unmet medical need.
  • The initiative aims to generate data for potential registrational studies and regulatory pathways, with Invivyd planning FDA discussions on rapid approval pathways for COVID-19 monoclonal antibodies.

Headlands Research Expands to Caribbean with CMRCenter Acquisition, Enhancing Hispanic Patient Access to Clinical Trials

  • Headlands Research acquired CMRCenter (CMRC) in San Juan, Puerto Rico, expanding its clinical trial network to 22 sites across the United States, Canada, and Puerto Rico.
  • The acquisition provides pharmaceutical sponsors streamlined access to one of the largest Hispanic patient populations under FDA oversight, with CMRC maintaining a 90% retention rate in trials.
  • CMRC brings expertise in CNS disorders, vaccines, and specialty conditions, with a bilingual team and database of over 10,000 engaged participants.
  • The deal combines CMRC's local knowledge of Puerto Rico's medical and regulatory landscape with Headlands' centralized infrastructure to accelerate clinical research.

Argon AI Secures $5.5M to Transform Pharmaceutical Data Management with AI-Native Workspace

AI
  • Argon AI raised $5.5 million in seed funding led by Crosslink Capital and Wireframe Ventures to develop an AI-native workspace specifically designed for life sciences companies.
  • The platform addresses critical inefficiencies in pharmaceutical data management, where internal data doubles every two years and teams process tens of thousands of documents annually in unwieldy formats.
  • Argon's AI-enabled workspace integrates internal company data with proprietary clinical and commercial databases, automating tasks like market research, competitive tracking, and clinical trial benchmarking.
  • The company is already working with two top-15 global pharmaceutical companies and deployed at premier consulting firms, with potential to save millions in misdirected R&D spending.

Delhi High Court Orders CDSCO to Review Safety of GLP-1 Diabetes Drugs Used for Weight Loss

Drug Approval
  • The Delhi High Court has directed India's Central Drugs Standard Control Organisation (CDSCO) to decide within three months on a petition challenging the licensing of GLP-1 receptor agonist drugs for weight loss treatment.
  • The petition raises safety concerns about semaglutide, tirzepatide, and liraglutide being approved for weight management despite limited India-specific clinical trial data and inadequate safety evaluation.
  • These drugs were originally developed for Type 2 diabetes treatment but have been repurposed for obesity management, with the petitioner citing risks including pancreatitis, gastrointestinal damage, and potential cancers.
  • The court emphasized that CDSCO must consult experts and relevant stakeholders before making its decision on the regulatory concerns raised in the petition.

BioVersys and Shionogi Form Strategic Partnership to Develop Novel NTM Treatments Worth Up to CHF 484 Million

  • BioVersys and Shionogi have entered a research collaboration and exclusive license option agreement to develop novel ansamycin leads from BioVersys' BV500 program targeting non-tuberculous mycobacteria infections.
  • The partnership includes CHF 5.0 million in upfront and research payments, with potential regulatory and sales milestones reaching CHF 479 million plus tiered royalties on global sales.
  • The BV500 program addresses a critical unmet medical need, as NTM pulmonary disease affects approximately 250,000 people annually with limited effective treatment options.
  • BioVersys' lead candidates demonstrate broad-spectrum anti-NTM activity without cross-resistance to existing therapeutic classes, potentially offering superior treatment outcomes for patients with these challenging infections.

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