This page provides educational resources, events, news and products related to pharmacovigilance. Content will cover aspects from drug and vaccine safety and efficacy to surveillance and strategies to manage and investigate adverse events.
Pharmacovigilance – Highlights
Exploring the Drug Development Process
Drug development is the process of bringing a novel drug from “bench to bedside”. It can take 10 to 15 years for a drug to be designed, developed and approved for use in patients. Here, we take a closer look at the multi-step process of developing a drug – from start to finish.
Nitrosamine Impurities in Medicines
In this article, we take a closer look at nitrosamines, how they are created, the related health concerns and provide examples of nitrosamine impurities that have been detected.
Risk Assessment and Expert Review of N-Nitrosamine Contaminants
In this article, David Elder discusses the identification of N-nitrosamine impurities in valsartan drug substances products in mid-2018 and highlights the regulatory response, sources of contamination and analytical methods used for identifying nitrosamines.
Testing a Drug Compound in Clinical Trials
In a recent interview with Technology Networks, Dr Stephen Wright, Independent Consultant in medicines development, talks us through the various stages of clinical drug development. He explains what is meant by an IND application, discusses how clinical trials are designed and how the data generated in these trials is processed.
New Molecular Drivers of Retinoblastoma Identified
Researchers have identified a molecule that becomes hyperactive and promotes tumor survival in retinoblastoma, a poorly understood cancer.
Using Combi-Seq To Screen Personalized Anti-Cancer Drug Combinations
A new study has proposed a new approach that may increase the power of drug efficacy testing and pave the way for more personalized cancer therapy.
Trip-Free LSD-Like Molecules Produce Antidepressant Effects in Mice
Scientists have designed compounds that hit the same key receptor that LSD activates without causing hallucinations. A single dose produced powerful antidepressant and antianxiety effects in mice that lasted up to two weeks.
New Treatment for Uterine Fibroids Shows Promise in Trial
Researchers have developed a new, more patient-friendly drug that could revolutionize the way some of the most common gynecological diseases such as fibroids and endometriosis are treated.
Experimental Alzheimer’s Drug Lecanemab Slows Cognitive Decline in Clinical Trial
A significant development in Alzheimer’s disease research has been announced by the drug company Eisai. In a press release, the company said that their investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab has produced modest but highly statistically significant results in trial.
Molecular Devices and HeartBeat.bio Announce Collaboration To Automate and Scale Cardiac Organoids
Molecular Devices, LLC. and HeartBeat.bio AG, a biotech company developing cardiac organoids for drug discovery, have entered into a co-development agreement.
Voltron Therapeutics, Inc. Announces Definitive Proof of Concept Data for its Lead Oncology Candidate
Voltron Therapeutics, Inc. has announced that data from the previously announced Study ‘098 demonstrated clear Proof-of Concept for VTX-067 in the treatment of HPV-related cancers.
Epilepsy Patients Set To Benefit From Non-Invasive, Real-Time Molecular Breath Analysis
Deep Breath Intelligence is pleased to announce the launch of a simple breath test that can provide reliable estimates of circulating concentrations of the antiseizure medication valproic acid to aid patient management.