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The health technology assessment agency has recommended in final draft guidance that Opdivo (nivolumab) plus Yervoy (ipilimumab) be used on the NHS in England,...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...
UK – AstraZeneca’s Truqap recommended by NICE to treat advanced breast cancer
The health technology assessment agency has recommended in final draft guidance that the drug be used in combination with AZ’s endocrine therapy Faslodex (fulvestrant)...
Europe – Revised general chapters for elemental analysis published in Pharmeuropa 37.2
Analytical procedures for elemental analysis are described in the following European Pharmacopoeia (Ph. Eur.) general chapters:
2.2.22. Atomic emission spectrometry;
2.2.23. Atomic absorption spectrometry;
...
USA – FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies...
Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of...
UK – First treatment for common bladder cancer recommended by NICE
Balversa (erdafitinib) has been recommended for use on the NHS as the first and only treatment in the UK for urothelial cancer (UC) involving...
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...
