Image Credit: © Crystal light – stock.adobe.com Adicet Bio has announced that the FDA has cleared its Investigational New Drug (IND) application to evaluate ADI-270, an armored allogeneic “off-the-shelf” gamma delta chimeric…
Category: Medicine
Results from Phase III Trials Show Eli Lilly’s Tirzepatide Reduces Obstructive Sleep Apnea Severity
Image Credit: © terovesalainen – stock.adobe.com Eli Lilly has announced results from its Phase III clinical trials of tirzepatide for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity,…
Usage of Patient-Reported Outcomes in Blood Cancer Clinical Trials
Image Credit: © putilov_denis – stock.adobe.com In recent years, there has been a growing interest in the use of patient-reported outcomes (PROs) in clinical trials. When it comes to evaluating subjective symptoms,…
The Shift Toward Precision Medicine Requires Claims Data Insights
Healthcare today is evolving into precision medicine, or what the FDA refers to as personalized medicine. To stay competitive in the constantly shifting healthcare landscape, organizations across the healthcare ecosystem must embrace…
Accelerating the Use of RWD for Oncology Clinical Trial Planning
As medical facilities become more equipped to handle different telemedicine platforms and procedures, more clinical trials are back up and running. This also means more electronic data is being generated than ever….
Emerging Biosimilars and the Importance of Identifying Experienced Providers
Although biologics and biosimilar drugs only represent 2% of U.S. prescription volume, these naturally sourced medications have recently become the focus of much discussion across healthcare channels. Biologics – often considered specialty…
Phase III GRAVITI Trial Data Power sBLA Submission for Tremfya to Treat Crohn Disease
Image credit: Matthieu | stock.adobe.com Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the FDA for Tremfya (guselkumab) subcutaneous (SC) induction for the treatment of adult patients with moderately…
Accelerating Clinical Trial Activation
Sandra Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG. Site activation of new clinical trials remains a top priority at most clinical research sites. But there…
Ginny Beakes-Read of Johnson & Johnson Discusses Regulatory Challenges
ACT: What are currently some of the greatest regulatory challenges industry stakeholders such as CROs and sponsors should be keeping top of mind? How can they be addressed? Beakes-Read: Some of the…
Pivoting Toward Sustainable Supply Chains in Clinical Research
Image credit: Corona Borealis | stock.adobe.com The clinical research industry has historically operated with a focus on effectively and efficiently delivering therapies that will benefit patients. Now, sustainability and environmental considerations are…