International – Bébé-Crispr : la modification du génome d’embryon bute sur des obstacles techniques
Une décennie après son déferlement dans les laboratoires, l’outil de modification du génome Crispr-Cas9 alimente toujours une révolution scientifique et médicale et continue de...
USA – How to learn about biologics CMC: advice on technical issues, regulatory strategy,...
Chemistry, manufacturing and controls (CMC) are an integral step in creating an effective biological product — and a crucial element of an effective biologics...
USA – FDA drafts guidance on pediatric clinical pharmacology studies
The US Food and Drug Administration (FDA) has laid out its thinking on the ethical and physiological issues sponsors should consider when planning to...
Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents...
UK – AstraZeneca and Amgen’s Tezspire recommended by NICE for severe asthma
The final draft guidance from the National Institute for Health and Care Excellence (NICE) specifically applies to patients who are inadequately controlled with high...
USA – FDA issues guidance on assessing quality of topical ophthalmic drugs
The US Food and Drug Administration (FDA) issued new draft guidance recommending a battery of studies that manufacturers should use to assess the quality...
USA – FDA revises IEM drug draft guidance to clarify food standards, use of...
The US Food and Drug Administration (FDA) has issued a revised draft guidance on developing drugs to treat inborn errors of metabolism (IEM) to...
Europe – EMA updates Q&A document on publication of clinical trial data
In December 2018 all Clinical Data Publication (CDP) activities were suspended due to the
implementation of the EMA’s business continuity plan (BCP). During the COVID-19...
Europe – Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global regulatory workshop on COVID-19 observational studies and...
UK – NICE issues two recommendations for UCB’s inflammatory disease drug
Bimzelx, which is already authorised in the UK to treat certain patients with plaque psoriasis, is now the first treatment available for PsA and...
