Drug safety

#ADME / Tox #Artificial intelligence (AI) #AstraZeneca #Collaboration #Drug safety #Tremont AI

Research collab will build AI solutions for accelerated safety screening

AstraZeneca and Tremont AI have announced a research collaboration to develop and evaluate AI solutions for accelerated safety screening in preclinical toxicologic pathology studies.  Assessing the safety of a new drug is one of the most demanding steps before it can reach patients.  Toxicologic pathologists… Read More

#News

Human heart
#Cardioprotection #Drug safety #Guide

Read the Guide: Predict cardiac safety early

Download now to read this new Guide from sponsors Apconix. Cardiac safety doesn’t stop with hERG. When it comes to cardiac safety, an integrated approach supports informed decision-making. Discover the importance of the four nonclinical cardiac safety assessments Understand the benefits of each assessment Develop a comprehensive cardiac safety evaluation… Read More

#News

#Drug discovery #Drug safety #Regulatory

How smaller pharma teams are rethinking safety surveillance 

As global regulatory expectations rise around proactive real-world safety monitoring, smaller marketing authorisation holders risk being caught off-guard with their reliance on rudimentary signal detection practices. Current processes may not support the structured, statistics-based approach favoured by larger companies and expected by health authorities. But there are other practical options… Read More

#Exclusive Content

#Cardioprotection #Drug discovery #Drug safety #Drug toxicity #Whitepaper

Whitepaper: Transforming cardiac safety testing

Discover how VOLTA Scanner is transforming cardiac safety testing. This Whitepaper from Lumencor describes an optophysiology instrument, supporting stable, fast, high-resolution toxicity testing and drug development. Download to learn how: VOLTA detects early-after-depolarisations (EADs), and predicts QT/QRS risk Optogenetic pacing improves assay precision Automated, HPT optophysiological screening streamlines… Read More

#News

#Cardioprotection #Drug discovery #Drug safety #Drug toxicity

VOLTA Scanner illuminates cardiac safety testing

VOLTA Scanner is transforming cardiac safety testing. This whitepaper describes an optophysiology instrument, supporting stable, fast, high-resolution toxicity testing and drug development. Download to learn how: VOLTA detects early-after-depolarisations (EADs), and predicts QT/QRS risk Optogenetic pacing improves assay precision Automated, HPT optophysiological screening streamlines decisions… Read More

#Resources

#Advertorial #Drug discovery #Drug safety #Electrophysiology

VOLTA Scanner: An optical kinetic plate reader for cardiac safety testing

This advertorial for Lumencor appeared in DDW Volume 26 – Issue 2, Spring 2025 Read the digital issue VOLTA is an automated kinetic plate reader for high-throughput cardiac electrophysiology. An optical alternative to patch clamp analyses, it simultaneously scans 96 wells at 10,000 Hz resolution in less than two minutes… Read More

#Exclusive Content

Drugs targeting amyloid Plaque
#Alzheimer's #Drug safety #Eisai #Monoclonal antibodies #National Institute for Health and Care Excellence (NICE)

Researchers call for extra safety monitoring of lecanemab

Researchers from the UK’s Drug Safety Research Unit are calling for the robust monitoring of the safety of lecanemab, a new drug to treat Alzheimer’s disease (AD).  In a review article, published in the British Journal for Clinical Pharmacology, the researchers discuss the need for ongoing assessment of the safety… Read More

#News #Regulatory #Trending News

#Drug development #Drug discovery #Drug safety #Drug screening #Mitochondria #Toxicology

App Note: Measure mitochondrial toxicity using primary hepatocytes

Mitochondrial dysfunction is known to play a central role in drug-induced hepatotoxicity, and thus early detection of mitochondrial toxicity is a critical component of initial drug development efforts. While immortalised cell lines are widely used for in vitro assessment of hepatotoxicity, cryopreserved primary human hepatocytes are a preferred model for drug… Read More

#News

#Drug development #Drug discovery #Drug safety #Drug screening #Mitochondria #Toxicology

Measurement of mitochondrial toxicity using primary hepatocytes

Mitochondrial dysfunction is known to play a central role in drug-induced hepatotoxicity, and thus early detection of mitochondrial toxicity is a critical component of initial drug development efforts. While immortalised cell lines are widely used for in vitro assessment of hepatotoxicity, cryopreserved primary human hepatocytes are a preferred model for drug… Read More

#Resources

Human heart model
#Adverse event #Cardiovascular disease #Drug safety #Drug screening #iPSC #Organ-on-a-chip

Miniature human heart has potential to reshape drug testing

A tiny human heart model could potentially transform cardiovascular research and enable animal-free drug testing. A team of researchers, led by the Hebrew University of Jerusalem (HU), has developed a self-paced, multi-chambered human heart model, approximately half the size of a rice grain. “Integrating… Read More

#Editor's Choice #News

#ApconiX #Biosafety testing #Drug safety #Interview #Podcast #Sitting Down With podcast

What are the benefits of a target safety assessment?

In a DDW Sitting Down With podcast with Lu Rahman, Ruth Roberts and Claire Sadler, ApconiX, discuss the benefits of performing a target safety assessment (TSA) during drug discovery and development when a biological target is going to be acted on by a drug. The background In this podcast, Professor… Read More

#Exclusive Content

Ozempic box
#Adverse event #Diabetes #Drug safety #EMA #Type 2 diabetes

EMA reviews drug data relating to suicide risk

The European Medicines Agency (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), is reviewing data on the risk of suicidal thoughts and thoughts of self-harm related to GLP-1 receptor agonists. The drugs under review include Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide), used for weight… Read More

#News

#ApconiX #Drug safety #Interview

New podcast: Why is a target safety assessment so important?

The latest sponsored DDW Sitting Down With podcast is now live. Professor Ruth Roberts, Co-Founder ApconiX, and Claire Sadler, Project Toxicologist, discuss the benefits of carrying out a target safety assessment (TSA) during drug discovery and development whenever a biological target is going to… Read More

#News

#ApconiX #Drug safety #Interview #Sitting Down With #Sitting Down With podcast

How a target safety assessment supports the drug development process

In the latest sponsored DDW Sitting Down With podcast Professor Ruth Roberts, Co-Founder ApconiX, and Claire Sadler, Project Toxicologist, discuss the benefits of carrying out a target safety assessment (TSA) during drug discovery and development whenever a biological target is going to be modulated. The speakers outline… Read More

#Podcasts

#Animal models #Animal testing #Drug discovery #Drug safety #FDA #Regulatory

What does the FDA animal testing legislation mean for drug discovery? 

As of late December 2022, the US Food and Drug Administration (FDA) no longer needs drugs to be tested in animals to receive approval, according to legislation signed by President Joe Biden1 – the Modernization Act 2.0. This news has been shared widely as a landmark moment, especially in the eyes… Read More

#Business & Investment #Exclusive Content #Opinion #Regulatory #Trends & Analysis

#Automation / robotics #Drug safety #Pharmacovigilance

Quality overtakes cost as the priority for automating PV reporting

New research, involving 200 professionals in senior roles spanning pharmacovigilance (PV), Drug Safety and Product Safety departments, has found that quality has overtaken cost as a priority in plans for automating adverse event (AE) reporting. John Price, life sciences industry consultant and partner of Arriello, which commissioned this latest research, reports on the findings.  Although the Covid-19 pandemic has… Read More

#Editor's Choice #Exclusive Content #Intelligence #Market Reports #News #Opinion #Trends & Analysis