Image credit: blueringmedia | stock.adobe.com The FDA has granted Fast Track Designation (FTD) to RemeGen Co. Ltd’s mesothelin-targeting antibody-drug conjugate (ADC) RC88 to treat patients with platinum-resistant recurrent epithelial ovarian, fallopian tube,…
Category: Medicine
How Often are Registered Clinical Trials Publishing Their Results?
Image Credit: © FlowStudio – stock.adobe.com A commentary recently published on JAMA Network examined how often registered clinical trials are publishing their results.1 The cross-sectional study analyzed 308 clinical trial protocols published…
Recent Study on Multiple Sclerosis Identifies Biomarkers for Long-term Disability in Patients
Image Credit: © Aerial Mike – stock.adobe.com A recent study discovered a combination of 11 proteins that can predict long-term disability in patients with multiple sclerosis (MS). The study, conducted by researchers…
Microbiology is Vital to Compliance to Annex 1 and Risk-Based Regulation
Image credit: Yuliia | stock.adobe.com On November 23, 2023, the PDA Ireland Chapter hosted an event on Microbiology – The Key to Compliance with Annex 1 and Risk Based Regulations. This sold-out…
FDA to Evaluate New Drug Application for Unique Injectable Oncology Therapy
Image credit: Iryna | stock.adobe.com The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug…
Upping the Ante for Predicting the Success of Alzheimer Disease Treatments
Image credit: BillionPhotos.com | stock.adobe.com Over the past 20 years, less than a handful of completed Phase III Alzheimer disease (AD) clinical trials have been successful. Despite large investments of capital and…
Study Finds Low Representation of Disabled Participants in Cardiac Clinical Trials
Despite regulatory guidance, disability status is frequently unreported or overlooked in trial design. A study recently published in the Journal of the American Heart Association found low representation of individuals with disabilities…
Combining Awareness and Innovation
Published on: December 1, 2023 Jared Baeten, Vice President, Clinical Development, HIV Franchise Head at Gilead Sciences highlights how awareness and clinical innovation have transformed research in the HIV space. Jared Baeten, Vice…