Europe – EMA Consults on Genetically Modified Cell Products Guideline
The European Medicines Agency (EMA) on Tuesday released a draft revision of its 2012 guideline covering quality, non-clinical and clinical aspects of medicines containing...
UK – Final NICE green light for Pfizer’s Mylotarg
The guidelines, which do not cover the treatment of acute promyelocytic leukaemia, endorse NHS funding for patients aged 15 years and over, but only...
Europe – Member states contact points for translations review
The e-mail should include at least the following information:
E-mail subject: Post-opinion review – Day <…> – <Product name> - <EMEA procdure number>
Deadline for comments:...
Europe – COVID-19: What’s new
The latest updates on the COVID-19 pandemic from the European Medicines Agency (EMA), including all news and press releases, are available below...
Europe – EMA and EC action plan on paediatrics
The EU’s regulatory framework for paediatric medicines, the Paediatric Regulation1, came into force in 2007. In 2017, the European Commission’s (EC) issued their ten-year...
Europe – L’essai des pyrogènes sur lapin bientôt supprimé de la Pharmacopée Européenne
Lors de sa 170e session (juin 2021), la Commission européenne de Pharmacopée a décidé de prendre des mesures qui devraient permettre le remplacement total de l’essai...
Europe – COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE)
Summary
Immune thrombocytopenia (ITP):
• Cases of ITP, some with very low platelet levels (<20,000 per μL), have been reported very rarely, usually within the first...
UK – NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer
According to the Institute, while Caprelsa (vandetanib) may delay the disease getting worse compared with best supportive care, “but the benefit is uncertain”.
Also, it...
UK – Trivalent gets UK green light for flu in over 65s
As a population that is particularly vulnerable to influenza infection and its complications this is a welcome decision, as it means the UK is...
UK – Complex Cancer Trials: Group of UK Experts Offers Recommendations
As the use of complex innovative design (CID) trials for new cancer treatments continues, a group of UK professors from the University of Oxford,...
