International – ICH signs off on carcinogenicity testing addendum
The International Council for Harmonisation (ICH) recently announced that its S1B(R1) addendum outlining a “weight of evidence” (WoE) approach to assess the human carcinogenic...
International – Novartis confirms death of 2 children after gene therapy
Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention.
Two children...
International – ICH M10 on bioanalytical method validation
This guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the...
International – Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines
Infectious disease experts from Asia reviewed data from the VIEW-hub database on vaccine use and impact, developed by John Hopkins Bloomberg School of Public...
International – Pfizer and BioNTech share positive results for Omicron-adapted COVID-19 vaccine
The data shows that a booster dose of both Omicron-adapted vaccines gave a considerably higher immune response against Omicron BA.1, compared to Pfizer/BioNTech’s current...
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...
