UK launch for Alliance’s pregnancy anti-nausea and vomiting drug

Europe – UK launch for Alliance’s pregnancy anti-nausea and vomiting drug

Xonvea is a fixed-dose combination of 10mg doxylamine succinate (histamine H1 receptor antagonist) and 10mg pyridoxine hydrochloride (vitamin B6 pro-drug) formulated as lactose-free, gastro-resistant,...
Ajovy bags NICE approval

UK – NICE turns down Opdivo/Yervoy combo for kidney cancer

Explaining the decision, the Institute said that while clinical trial evidence shows that the Opdivo (nivolumab)/Yervoy (ipilimumab) combination “is substantially more effective” than Pfizer’s...
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...
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – Withdrawal of the United Kingdom and EU rules for batch testing of...

This information is addressed to the EU27 Heads of Medicines Agencies and to the Executive Director of the European Medicines Agency (EMA). The United Kingdom...
Top 9 Companies in the Diagnostics Market

International – Top 9 Companies in the Diagnostics Market

Add some market clearances; a rebranding; a merger or two; and some collaborations; and you’ve got a recipe for some of the most powerful...
EMA Management Board – highlights of March 2020 meeting

Europe – EMA Management Board – highlights of March 2020 meeting

EMA’s first Management Board meeting of 2020 was held virtually in view of the rapidly changing situation in the context of the COVID-19 pandemic....

USA – Special Protocol Assessment Guidance

This guidance provides information on the procedures and general policies adopted by the Center for Drug Evaluation and Research (CDER) and the Center for...
New guidance on biologics affects authorized generics

USA – Excipients group seeks GDUFA III participation

Increasing the timely, safe, and cost-effective availability of generic drugs requires that excipient issues be addressed as an integral part of the process, said...
Agnès BUZYN enclenche le dégel de 415 millions d'euros de crédits pour les établissements de santé

France – Le label « priorité nationale de recherche »

La délivrance du label de « priorité nationale de recherche » permettra : de bénéficier d’une communication spécifique par les ministères envers les chercheurs, investigateurs, promoteurs incitant à...

UK – NICE recommends Sobi’s Kineret for first-line use in Still’s disease

NICE has approved Kineret (anakinra) to treat systemic juvenile idiopathic arthritis (sJIA) in people aged eight months or over with a body weight of 10kg or...

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