While clinical trials and regulatory filings offer a semi-structured view of drug safety, a large amount of insights lie in sources ranging from patient support programs (PSPs) to social media posts. As Natural Language Processing (NLP) evolves, a growing number of tools are becoming available to unlock this potential. Deepanshu Saini, Director of Program Management…
The rise of ‘Ozempic babies’ and the uncharted territory of semaglutide in pregnancy
Ozempic, Rybelsus and Wegovy have transformed the diabetes and weight loss treatment landscape, but when it comes to the impact of their active ingredient, semaglutide, on fetal development, “the answer is we do not know,” said Dr. Marijane Hynes, clinical professor of medicine at the George Washington University School of Medicine and Health Sciences. Hynes…
Zepbound helps people lose 25% of body weight on average 88 weeks, but weight regain is a concern
Lilly’s hot weight loss drug Zepbound (tirzepatide) may be one of the most effective drug therapies for weight loss. In an open-label 36-week study, participants lost an average of 20.9% of their body weight in 36 weeks. With an average weight of 107.3 kg (236.5 lbs), that equates to about 22.4 kg (49.4 lbs) on average.…
Finding the right formula for nitrosamine risk mitigation
The pharmaceutical industry is facing many challenges to ensure drug products are free from nitrosamine contaminants and safe for human use. Since the discovery of potentially carcinogenic nitrosamines in some commonly prescribed drug products in 2018, mitigating nitrosamine risk has been a top priority for the pharmaceutical industry and its governing bodies. As such, strict…