International – Moderna announces trial results for new COVID-19 booster vaccine candidate
The analysis shows that the new vaccine offers better protection against Omicron than Moderna’s original vaccine, Spikevax, producing nearly double the neutralising antibody levels.
The...
International – ICH details milestones reached on guidelines after Athens meeting
The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for...
International – FDA, EMA officials discuss impediments to cell and gene therapies
The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a “playbook” or platform approach for developing multiple cell and...
International – International regulators and WHO: support healthcare professionals to enhance public confidence in...
EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). The statement is aimed...
International – WHO recommends Veklury for high-risk patients
The World Health Organisation (WHO) has recommended Veklury (remdesivir) for the treatment of patients with non-severe COVID-19 who are at the highest risk of...
International – ICH plans model-informed drug development guideline in 3-4 years
The International Council for Harmonisation (ICH) released a widely anticipated timetable detailing its plans to issue general guidance on model-informed drug development (MIDD) approaches...
International – Mechanical, material stresses affect drug quality
Making medicines is a stressful business, literally. Bioprocessing technologies, cleaning agents, and even packaging can create stresses that impact drug quality. Understanding these stresses...
International – ICH releases draft guidelines on analytical method development
The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for...
International – Excipient group releases guide on reporting microplastic use in pharmaceuticals
The International Pharmaceutical Excipients Council (IPEC) has just released a how to guide to assist the pharmaceutical industry in complying with new labeling and reporting rules...
International – ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT...
This document describes a non-clinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. It includes information concerning non-clinical...
