EU Nods Pfizer’s Velsipity® for Ulcerative Colitis
Pfizer Inc. announced that the European Commission has approved VELSIPITY® (etrasimod) for the treatment of patients aged 16 and...
eCOA: Should Sponsors Give Clinical Sites More Control?
Electronic Clinical Outcome Assessments (eCOA) have significantly advanced clinical trials, offering a more accurate and efficient data collection method....
How To Overcome Large-Scale Clinical Trial EDC Migration
In an unprecedented move within the life sciences industry, Veeva announced the successful migration of 25 clinical studies for...
“Time is Life” – Pfizer Mantra for Revolutionizing Clinical Trials
February 12, 2024, marked a significant moment at the SCOPE Summit 2024 as Rob Goodwin, Sr. VP and Head...
How to Avoid The Dangers of Duplicate Participants in Clinical Trials
The prevalence of duplicate participants in clinical trials poses significant risks, compromising the integrity of data and the safety...
Datopotamab Deruxtecan BLA Accepted for US Lung Cancer
Daiichi Sankyo and AstraZeneca’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the U.S. FDA...
Tagrisso & Chemo Combo Approved in US for EGFR Lung Cancer
AstraZeneca’s TAGRISSO® (osimertinib), in combination with chemotherapy, has been approved in the US for the treatment of adult patients...
FDA OKs Xolair as Sole Drug for Multi-Food Allergies
Genentech, a member of the Roche Group, has announced the FDA approval of Xolair® (omalizumab) for reducing allergic reactions,...
How Practical Is FDA’s HCP Approach in DCTs?
The FDA’s latest guidance on Decentralized Clinical Trials (DCTs) marks a pivotal shift in the clinical research landscape. This...
Gilead Boosts Liver Portfolio by Acquiring CymaBay
Gilead Sciences, Inc. has agreed to acquire CymaBay Therapeutics, Inc. for $4.3 billion, expanding its portfolio with seladelpar, a...