Safety testing for coronavirus vaccine begins

USA – Antimalarial drugs, remdesivir tested for COVID-19

President Trump said in a Thursday press briefing that chloroquine and hydroxychloroquine, drugs used to treat malaria and severe arthritis, were approved by the Food and...
FDA Targets Faster Reviews for Biosimilar Supplements, Draft Guidance Says

USA – FDA Targets Faster Reviews for Biosimilar Supplements, Draft Guidance Says

The US Food and Drug Administration (FDA) on Thursday published new draft guidance explaining how it will speed its review of biosimilar or interchangeable...

International – Medical cannabis regulation is a global patchwork

The framework for regulating cannabis as a pharmaceutical product varies widely across the world, though increased clinical research into cannabis products means more approvals...

USA – GAO voices concern about FDA’s foreign drug inspection practices

A top official for the Government Accountability Office suggested the FDA is not adequately inspecting foreign drugmakers, leaving the U.S. drug supply chain vulnerable...
ANSM – Comité d’interface du 6 Février – EUDAMED

Europe – BPF : essai de libération en temps réel et libération paramétrique

La décision du 26/11/2020 du directeur général de l'ANSM a modifié les bonnes pratiques de fabrication : La ligne directrice particulière intitulée "Libération paramétrique" figurant...
Philippe Tcheng élu Président du Leem

France – Philippe Tcheng élu Président du Leem

Administrateur du Leem depuis 10 ans, Philippe Tcheng était jusqu’à ce jour membre du Bureau, trésorier et Président de la Commission des Affaires Scientifiques. Philippe...

UK – UK’s NICE recommends anti-cholesterol Leqvio for high-risk patients

The decision follows the agreement of a “population-level commercial deal” between the NHS and Novartis to make Leqvio “available with a discount to its...
Clinical Trial Regulation : Update

Europe – EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment...

Following EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio (molnupiravir) prior to marketing authorisation, the Agency will review more data...
New Council of Europe resolution to promote pharmaceutical care in Europe

Europe – Ph. Eur. launches a public consultation on a new general chapter for...

The European Pharmacopoeia (Ph. Eur.) seeks feedback on its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36). In line with the Decision...

USA – Novavax seeks FDA emergency approval for COVID-19 vaccine by May

Earlier this week, Erck told CNBC that the company’s discussions with the FDA are ongoing, but the hope is that the US regulatory agency...

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