Europe – European Commission approves ustekinumab for paediatric Crohn’s disease
The European Commission (EC) has approved ustekinumab for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40...
UK – Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathy
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which...
Europe – EPC adopts groundbreaking chapter on cell-based preparations for human use
After several years of work by the Cell Therapy Products Working Party (CTP WP), the European Pharmacopoeia Commission (EPC) adopted the new general chapter Cell-based...
Europe – Public consultation on revised general chapter 5.1.6. Alternative methods for control of...
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter 5.1.6. Alternative methods for control of microbiological quality, published in this...
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...
UK – NICE recommends brentuximab vedotin plus AVD for Hodgkin lymphoma
The National Institute for Health and Care Excellence (NICE) has recommended brentuximab vedotin combined with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients...
UK – Alcohol-mediated perivascular renal sympathetic denervation for resistant hypertension
Evidence-based recommendations on alcohol-mediated perivascular renal sympathetic denervation for resistant hypertension. This involves putting alcohol into the wall of a renal artery to destroy...
Europe – Streamlining development and assessment of biosimilar medicines
EMA is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. With over two decades...
Europe – Pharmeuropa 37.2 just released
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 37.2 is...
Europe – Development of a guideline on the quality aspects of mRNA vaccines –...
This guideline addresses the quality aspects of mRNA vaccines. It addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control of mRNA...
