EMA Consults on Genetically Modified Cell Products Guideline

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...
NICE ‘OK’ for Lynparza

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...
Clinical Trial Regulation : Update

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:...
EMA Management Board – highlights of March 2020 meeting

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...
Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) : Questions & Answers

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...
Nitrosamine contamination: new web page on EDQM response

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...
NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer

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...
Trivalent gets UK green light for flu in over 65s

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...
Complex Cancer Trials: Group of UK Experts Offers Recommendations

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,...

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