WHO drafts guidance for pharma supply chain tracking

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...
Trois nouvelles guidances du MDCG en Mars 2020

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...
Coronavirus delays many FDA foreign inspections

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The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out quality considerations for continuous manufacturing (CM) for new and generic...
Nitrosamine contamination: new web page on EDQM response

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...
FDA OKs Inotersen (Tegsedi) for Hereditary ATTR With Polyneuropathy

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...
EU files WTO dispute with Turkey over pharma laws

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...
EMA Takes Further Action in Ongoing Review of Tainted 'Sartans'

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,...
The impact of Mutual Recognition Agreement between the European Union and the United States as of 27 June 2019 : Questions & Answers

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...
NICE ‘OK’ for Lynparza

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...
Meeting highlights from the CHMP 24-27 February 2020

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...

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