UK – BMS receives NICE recommendation for immunotherapy combination in colorectal cancer
The health technology assessment agency has recommended in final draft guidance that Opdivo (nivolumab) plus Yervoy (ipilimumab) be used on the NHS in England,...
International – ICH releases overhauled stability guideline for consultation
The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and...
International – Clinical Trials Information System designated as WHO primary registry
The Clinical Trials Information System (CTIS) has been designated as a primary registry by the World Health Organisation (WHO) within the International Clinical Trials Registry Platform (ICTRP). Becoming a...
International – WHO adds first maternal RSV vaccine to prequalification list
The World Health Organization (WHO) has announced that it has added Pfizer’s maternal respiratory syncytial virus (RSV) vaccine to its list of prequalified vaccines.
Abrysvo,...
International – Health agencies recommend best practices for using surrogate endpoints
A consortium of health technology assessment (HTA) agencies has released a white paper that aims to help pharmaceutical manufacturers provide better data on using...
International – WHO guideline aims to facilitate the development of “more durable” pediatric medicines
The World Health Organization (WHO) has released a draft guideline to encourage the development of better-formulated and higher-quality pediatric medicines. The guideline targets member...
International – ICH adopts E6(R3) guideline on good clinical practices
The International Council for Harmonisation (ICH) announced on Tuesday the adoption of its E6(R3) guideline, which aims to harmonize the framework for conducting clinical...
Europe – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms –...
ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms...
International – Mpox : l’OMS approuve un second vaccin, fabriqué par une société pharmaceutique...
Un nouveau vaccin contre la mpox, fabriqué par la société pharmaceutique japonaise KM Biologics pour un usage d’urgence, a été approuvé, mardi 19 novembre, par...
International – Industry stakeholders call for changes to ICH M14 RWD guideline
Pharmaceutical industry stakeholders from both sides of the Atlantic generally supported the International Council for Harmonization’s (ICH) M14 guidance on using real world data...
