Pharmacovigilance is rapidly evolving in response to the dynamic landscape of healthcare, regulatory demands, and technological advancements. As the healthcare industry shifts toward more personalized and tech-enabled solutions, the role of pharmacovigilance becomes increasingly critical in safeguarding patient health and ensuring the continued efficacy and safety of therapeutic products. Adapting […]
Pharmacovigilance (PV) is defined as the science associated with monitoring and assessing the safety, efficacy and quality of drugs through pre-marketing and post-marketing surveillance. The main focus is to identify adverse effects that may arise from several pharmaceutical products. This process should be conducted throughout the entire lifecycle of the […]
Clinical Trials on Antibody–drug conjugates (ADCs) are gaining significant attention as a promising class of targeted anticancer therapies. The journey of ADCs began with Mylotarg, developed by Pfizer, which received its first regulatory approval in 2000. However, concerns related to safety led to its withdrawal a decade later. Its subsequent […]
Luckey et al., 2025(The Lancet): An international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial was conducted. The study evaluated the efficacy and safety of zoliflodacin versus ceftriaxone plus azithromycin in patients aged 12 years and older with clinical suspicion of uncomplicated urogenital gonorrhoea. Eligible participants were randomly assigned (2:1) […]
Zhang et al 2026 (JAMA): A large long-term study followed over 131,821 people from Nurses’ Health Study and the Health Professionals for up to 43 years to examine whether drinking coffee or tea affects the risk of dementia. During the study 11,033 develop dementia. Study revealed that higher caffeinated coffee […]
Luciano et al., 2025 (N Engl J Med): A randomized, double-blind, placebo-controlled trial of shunt surgery was conducted among 99 participants having idiopathic normal pressure hydrocephalus (iNPH). It was observed that shunt surgery increases the gait velocity and was found unchanged in the placebo. A significant difference favoring shunt surgery […]
Estrella et al 2025(JAMA): A Meta-Analysis of 821327 outpatient participants and nearly 39 639 hospitalized patients who had both creatinine and cystatin C based eGFR measurements were conducted. Participants were followed for an average of 11 years to evaluate long term outcomes. The analysis showed that approximately 11% of outpatients and […]
Wharton et al., 2025 (N Engl J Med): In a phase 3 multinational, randomized, double-blind trial, Orforglipron, a small-molecule, nonpeptide GLP-1 receptor agonist, was investigated as a treatment for obesity. The safety and efficacy of orforglipron at doses (mg) of 6, 12, or 36 once-daily, as compared with placebo (assigned […]
Drug development refers to the process of bringing a new drug molecule into the market through preclinical and clinical practice. It requires substantial investments in terms of capital (∼$2.2 billion), human resources, research skills, and technological expertise. The process of drug development can be broadly classified into preclinical and clinical studies. The […]
HEOR : In the ever-evolving healthcare landscape, the field of Health Economics and Outcomes Research (HEOR) has emerged as a crucial discipline to bridge the gap between clinical trials and real-world healthcare outcomes. While clinical trials provide essential data on the efficacy of medical treatments, they often fall short of […]