Data Dose January 2025 #1
Pharmacovigilance Medical Literature Monitoring Time Management Tips for 2025.
Pharmacovigilance professionals face constant pressure to manage their time effectively while ensuring patient safety. Tasks like monitoring medical literature, reporting adverse drug reactions (ADRs), and tracking safety signals demand precision and efficiency, as delays can have serious consequences. Medical literature monitoring (MLM) is a cornerstone of pharmacovigilance, essential for identifying ADRs, maintaining regulatory compliance, and protecting public health. However, the growing volume of publications and evolving regulations make MLM increasingly time-intensive. Here are some practical tips to help streamline your MLM process and stay ahead in this vital responsibility. Read more...
A real-world pharmacovigilance analysis of potential ototoxicity associated with sacubitril/valsartan based on FDA Adverse Event Reporting System (FAERS).
Sacubitril/valsartan, a groundbreaking angiotensin receptor neprilysin inhibitor, is a cornerstone treatment for heart failure. While its efficacy is well-documented, the drug is also associated with adverse effects like hypotension, renal dysfunction, hyperkalemia, and angioedema. However, ototoxicity—a less commonly reported side effect—has received limited attention in clinical studies and real-world settings. This study systematically analyzed post-marketing data to characterize ototoxicity linked to sacubitril/valsartan. Read more...
A public health emergency is waiting at the bottom of the antibiotic resistance cliff.
Antibiotic-resistant bacteria could trigger a global health crisis, with infection-related deaths rising sharply, warns new research from Northern Arizona University. Published in Communications Medicine, the study highlights the threat of multidrug-resistant and pan-resistant bacteria, which could cause sudden and severe public health impacts. Lead author Benjamin Koch stresses the urgency of addressing this escalating issue before it surpasses current projections. Read more...
Curocell develops Limkato, Korea's first CAR-T therapy with superior efficacy.
The localization of chimeric antigen receptor T cell (CAR-T) therapy, hailed as a "dream cancer treatment," is nearing reality in South Korea. If approved, patients could access Limkato (Anbasel), a more effective and affordable alternative to Novartis's Kymriah, by late next year. Curocell, the first South Korean company to develop a CAR-T therapy, recently submitted its product for licensing to the Ministry of Food and Drug Safety. CAR-T therapy enhances T cells to precisely target cancer cells, boosting efficacy while minimizing side effects. Read more...