International – Coronavirus : l’OMS réfute l’utilisation de médicaments sans preuve d’efficacité
« Ces morts et ces contaminations sont des chiffres tragiques, mais n’oublions pas que dans le monde entier, il y a des centaines de...
Europe – EU invests €35 million to develop Artificial Intelligence solutions for cancer prevention...
Today the European Commission launched a call for proposals with €35 million available aimed to support the development of analysis of health images for cancer diagnostics...
USA – Continuous Manufacturing: FDA Drafts Quality Guidance
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic...
Europe – Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs
The European Commission has issued its final legally binding decision on medicines containing valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019. This decision was...
USA – FDA OKs Inotersen (Tegsedi) for Hereditary ATTR With Polyneuropathy
The US Food and Drug Administration (FDA) has approved inotersen (Tegsedi, Akcea Therapeutics and Ionis Pharmaceuticals) for the treatment of polyneuropathy (PN) in adults...
International – EU files WTO dispute with Turkey over pharma laws
According to Commissioner for Trade Cecilia Malmström, Turkey is effectively forcing manufacturers of pharmaceuticals to move production into the country if they want their...
International – EMA Takes Further Action in Ongoing Review of Tainted ‘Sartans’
China's Zheijiang Huahai Pharmaceuticals (ZHP), the company at the center of the tainted valsartan crisis, will face increased scrutiny over other substances they produce,...
Europe – EMA: More Staff Than Anticipated Quit Ahead of Brexit Relocation
The European Medicines Agency (EMA) says it will further scale back operations as staff who do not intend to relocate to Amsterdam next year...
UK – NICE rejects Lilly’s breast cancer drug Verzenios
The preliminary guidelines do not recommend Verzenios (abemaciclib), in combination with an aromatase inhibitor, for some types of breast cancer that has spread.
According to...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee : 10-13 February 2020
PRAC recommends restrictions in use of cyproterone due to meningioma risk
Following a review of the risk of meningioma (a rare tumour of the membranes covering...
