BREXIT : où en est-on ?

UK – Industry Finds Fault With UK Vision for Drug Regulation After Brexit

British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The...
NICE ‘OK’ for Lynparza

UK – NICE nod for Jazz’ AML chemo

In a Final Appraisal Determination the Institute has approved funding for the drug when used to treat adults with newly diagnosed, therapy-related t-AML or...
Organs, Tissues and Cells - Technical Guides

Europe – Organs, Tissues and Cells – Technical Guides

Guide to the quality and safety of organs for transplantation Transplant medicine and transplantation have progressed during the last decades in a way that nobody would...
How the New Free From Claims Impact the European Cosmetics Space

Europe – EU Regulators Send Statements of Non-Compliance for Drugmakers in Spain, Italy, India

A handful of statements of non-compliance with good manufacturing practice (GMP) have been posted to the EudraGMDP database, including ones sent to Spain’s Genfarma...
Supply unlicensed medicinal products (specials)

UK – Supply unlicensed medicinal products (specials)

Details This Medicines and Healthcare products Regulatory Agency (MHRA) guidance is for those who want to manufacture, import, distribute or supply unlicensed medicines for human...
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...
EMA’s Rasi on Genome Editing: Time to Move Forward

Europe – EMA’s Rasi on Genome Editing: Time to Move Forward

For genome editing technologies in drug development, the European Medicines Agency’s (EMA) executive director Guido Rasi said recently that it’s time to not just...
AbbVie’s Venclyxto hit with NICE rejection

UK – AbbVie’s Venclyxto hit with NICE rejection

The National Institute for Health and Care Excellence said there were uncertainties with both the clinical evidence and the economic modeling provided. Clinical trial evidence...
NICE grants Lynparza expansion for advanced ovarian cancer

UK – AbbVie’s Venclyxto hit with NICE rejection

The National Institute for Health and Care Excellence said there were uncertainties with both the clinical evidence and the economic modeling provided. Clinical trial evidence...
NICE refuses Keytruda, Inlyta cancer combo

UK – NICE turns down hyperkalaemia therapies

Hyperkalaemia is characterised by elevated potassium levels in the blood. Risk of developing the condition increases significantly for patients with chronic kidney disease and...

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