Europe – PRAC starts review of topiramate use in pregnancy and women of childbearing...
EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during...
Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
EMA’s human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron...
USA – FDA authorizes Pfizer and Moderna’s bivalent COVID vaccines
The US Food and Drug Administration (FDA) on Wednesday authorized bivalent COVID-19 vaccines targeting the Omicron BA.4/5 subvariants developed by Pfizer-BioNTech and Moderna, asserting...
Europe – EU issues long-awaited GMP Annex 1 revision
The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years...
Europe – Patient registries: EMA officials highlight opportunities in orphan drug development
Officials from the European Medicines Agency (EMA) tout the benefits of patient registries to support regulatory decision making for orphan medicinal products in a...
Europe – EMA accepts application for leukaemia drug from Otsuka and Astex
The application is supported by positive results from the phase 3 ASCERTAIN clinical trial which demonstrated an exposure equivalence of an oral fixed-dose of...
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...
USA – European, US guidance differs on API nitrosamines
HARDLY A DAY goes by without mention of a newly emerging active pharmaceutical ingredient (API) nitrosamine, eg, nitrosamine propranolol.1 This has led to a great...
Asia – 3D-printed drug advancing to clinical trials in SE Asia
Craft Health’s tailored drug technology just received a boost. The Singapore 3D printed pharmaceuticals manufacturer announced it has raised S$1.42 million ($1.03 million) in...
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...
