International – Press Release: ICH Assembly Meeting, Madrid, Spain, May 2025
The Assembly of the International Council for Harmonisation (ICH) met in-person on 13 & 14 May 2025, in Madrid, Spain in parallel of meetings...
Europe – External guidance on the implementation of the European Medicines Agency Policy 0070...
The scope of this guidance document relates to phase 1 of Policy 0070 which excludes individual patient data (IPD). Article 17 of Regulation (EU)...
France – Cancers : en France, la création d’une nouvelle molécule conçue pour éliminer...
Comment éradiquer les cellules cancéreuses qui ont acquis la capacité de résister aux traitements standards et qui risquent de semer des métastases à travers...
UK – NHS and local government to roll out world-first vaccine programme to prevent...
Eligible patients, which includes gay and bisexual men who have a recent history of multiple sexual partners or a sexually transmitted infection (STI), will...
USA – FDA sets stricter approval standards for COVID vaccines
Over the past 5 years, the United States has moved toward an annual Covid-19 booster program. Each fall, Covid-19 booster shots are developed, alongside...
Europe – ETF recommends updating COVID-19 vaccines to target new LP.8.1 variant
EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant LP.8.1 for the 2025/2026 vaccination campaign.
LP.8.1 differs from the JN.1...
UK – MHRA approves first UK treatment for congenital thrombotic thrombocytopenic purpura (cTTP)
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (12 May 2025) approved rADAMTS13 (ADZYNMA), the first UK treatment to treat congenital thrombotic...
International – International group proposes best practices for AI in pharmacovigilance
The Council for International Organizations of Medical Sciences (CIOMS) has issued a draft report detailing a set of best practices to guide the integration...
Europe – EMA proposes to incorporate Annex 1 in GMP guide for ATMPs
The European Medicines Agency (EMA) plans to release a draft guideline that will integrate Annex 1 into Part IV of the Guidelines on Good...
France – Grippe saisonnière : la HAS précise la place des vaccins Efluelda et...
Infection respiratoire aigüe, la grippe saisonnière provoque chaque année un nombre important de décès et d'hospitalisations, notamment chez les personnes âgées, et une tension...
