Clinical Trial News
Alder BioPharmaceuticals Presents New Data on Eptinezumab's Clinical Profile for Migraine Prevention
Alder BioPharmaceuticals has unveiled new data from post-hoc analyses of its PROMISE-1 and PROMISE-2 Phase 3 clinical trials for eptinezumab, highlighting its potential in preventing migraines. The data, focusing on migraine-free months, severity, and quality of life improvements, supports eptinezumab's clinical profile. The findings were presented at the American Headache Society’s 61st Annual Scientific Meeting.
Clinical and Radiographic Evaluation of Biodentine in Revascularization of Non-Vital Immature Teeth
A study comparing the clinical and radiographic outcomes of using Biodentine versus white Mineral Trioxide Aggregate as coronal plug materials in the revascularization of non-vital immature teeth found no significant difference in success rates or root length increase, but a notable difference in tooth discoloration.
Feasibility of Monitoring Compliance with Intermittent Occlusion Therapy Glasses for Amblyopia Treatment
A study investigated the feasibility of using a microsensor to monitor objective compliance with intermittent occlusion (IO) therapy glasses in children with unilateral amblyopia. The study found that compliance varied among individuals and slightly declined over time, with an average compliance of 51.6%. Despite this, visual acuity improved in patients, indicating the potential effectiveness of IO therapy glasses. The study highlights the importance of monitoring compliance in amblyopia treatment and suggests that IO therapy glasses could be a viable alternative to traditional patching methods.
Highlighted Clinical Trials:
Salus University
Posted 12/19/2016
Salus University
Posted 9/1/2016
Real-World Evidence Transforms Drug Development: FDA Embraces New Paradigm in Clinical Research
• Real-world evidence (RWE) is revolutionizing drug development by providing crucial data from patient experiences outside traditional clinical trials, helping bring safer and more effective treatments to market.
• The FDA has demonstrated strong commitment to RWE adoption, exemplified by Pfizer's Ibrance receiving expanded indication for male breast cancer based solely on real-world data.
• RWE is being utilized across pharmaceutical functions, from informing clinical trial design to supporting market access decisions and value-based care initiatives worldwide.
Denali's Hunter Syndrome Candidate Receives FDA Orphan Drug and Rare Pediatric Disease Designations
Denali Therapeutics Inc. announced that its pipeline candidate, DNL310, has been granted orphan drug status and a rare pediatric disease designation by the FDA for the treatment of Hunter Syndrome, a rare lysosomal storage disease. The company plans to initiate a phase I/II study in 2020, following promising pre-clinical results.
SMi's 9th Annual Orphan Drugs Conference to Address Key Challenges in Rare Disease Treatment Access
• The 9th Annual Orphan Drugs & Rare Diseases Conference, scheduled for October 15-16 in London, will bring together experts to accelerate orphan drug development and improve patient access.
• Industry leaders, including NICE and Genetic Alliance UK representatives, will discuss critical issues such as early access programs, treatment value assessment, and manufacturer-payer dialogue.
• Conference co-chair Rick Thompson of Findacure emphasizes the event's focus on patient centricity and collaborative approaches in rare disease drug development.
Sequana Medical Receives FDA Approval for Alfapump Device Trial
Sequana Medical has obtained FDA approval for a pivotal study of its Alfapump device, aimed at treating patients with recurrent or refractory ascites due to liver cirrhosis. The study will enroll 60 patients in the U.S. and Canada, focusing on the device's effectiveness and safety.
Immunotherapy Drug Shows Potential to Cure Advanced Lung Cancer
A study involving Yale Cancer Center and Smilow Cancer Hospital researchers has shown that the immunotherapy drug pembrolizumab (Keytruda) significantly increases survival rates for patients with advanced non-small cell lung cancer (NSCLC), marking a significant advancement in lung cancer treatment.
Leading Pharma Companies Unite at Social Media Conference to Share Digital Innovation Strategies
• Twenty senior executives from major pharmaceutical companies including Pfizer, GSK, Merck, and AstraZeneca will convene to discuss compliant social media engagement strategies in London.
• The conference aims to address critical challenges in pharmaceutical digital communications, focusing on patient and healthcare professional engagement while maintaining regulatory compliance.
• Industry leaders will share insights on leveraging cutting-edge platform technologies and content strategies to demonstrate measurable impact and secure organizational buy-in for social media initiatives.
uniQure Announces Updated Clinical Data from Phase IIb Study of AMT-061 in Hemophilia B Patients
uniQure N.V. has released updated clinical data from its Phase IIb study of AMT-061, a gene therapy for hemophilia B, showing sustained increases in Factor IX (FIX) activity up to 57% of normal levels. The study, involving three patients, reported no bleeding events or need for factor infusions over 78 weeks. AMT-061 has received Breakthrough Therapy Designation and access to the PRIME regulatory initiative.