International – ICH Q14: Pharma groups want clarity on benefits of enhanced approach
Pharmaceutical industry groups questioned whether following the enhanced approach in International Council for Harmonization (ICH) Q14 guidance will confer regulatory relief for manufacturers that...
International – WHO reports warnings of ‘COVID-19 complacency’ from countries tracking global vaccine roll-out
Emphasising that the global pandemic is ‘not over’, the ACT-Accelerator’s Council Tracking and Accelerating Progress Working Group – co-chaired by Indonesia and the US...
International – Pfizer doses first patients with mRNA-based influenza vaccine
Each year, even when currently available vaccine strains match circulating influenza virus strains well, those vaccines typically offer only 40% to 60% protection, with...
International – Pharma groups question enhanced approach in Q14, call for more alignment between...
Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced...
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...
