Patient or Disabled Group
Recent Developments in Logistical Coordination for Decentralized Clinical Trials (DCTs)
Decentralized Clinical Trials; Logistics; FDA Guidance 2024; Remote Patient Monitoring; Supply Chain Management; Digital Trial Platforms
Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy
Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity
Trump Administration Unveils Health Data Sharing Scheme Backed by Apple, Amazon, and Others
Trump administration; health data sharing; CMS Interoperability Framework; Apple; Amazon; digital health records; patient data; privacy; tech partnerships
Rethinking Clinical Trial Data in the Era of Decentralization: Key Trends and Challenges (2025)
decentralized clinical trials; DCT; data quality; patient diversity; remote monitoring; AI in trials; data integration; risk-based oversight; clinical trial data; regulatory guidance
Bristol Myers Squibb and Pfizer Launch Direct-to-Consumer Discount Program for Eliquis
Bristol Myers Squibb; Pfizer; Eliquis; direct-to-consumer; discount; online program; Eliquis 360 Support; anticoagulant; blood thinner; patient access
Outsmarting Data Bottlenecks in Pharma: The Clinical Terminology Advantage
data bottlenecks; clinical terminology; pharmaceutical industry; data integration; interoperability; regulatory compliance; AI in pharma; patient outcomes
Recent Developments in Building Measurable Patient Support Programs (2025)
patient support programs; measurable outcomes; collaborative healthcare; 2025 trends; Medicare reforms; cost efficiency; access to care
FDA Investigates Patient Deaths Linked to Sarepta’s Elevidys Gene Therapy for Duchenne Muscular Dystrophy
FDA; Sarepta; Elevidys; Duchenne muscular dystrophy; gene therapy; patient deaths; acute liver failure; liver toxicity; regulatory investigation; non-ambulatory patients
Second Patient Dies After Receiving Sarepta’s Elevidys Gene Therapy for DMD
Duchenne muscular dystrophy; gene therapy; Sarepta Therapeutics; Elevidys; acute liver failure; AAV-based gene therapy; patient death; non-ambulatory patients; FDA; risk mitigation
Sarepta Halts Duchenne Gene Therapy in Some Patients After Second Death
Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; Elevidys; acute liver failure; non-ambulatory patients; FDA; clinical trial pause; immunosuppression; patient safety