Europe – EMA recommends withdrawal of marketing authorisation for amfepramone medicines

EMA’s safety committee (PRAC) has recommended the withdrawal of EU marketing authorisations for amfepramone obesity medicines. The recommendation follows a review which found that measures to restrict...

France – Intérêt du logiciel doté d’IA « PharmaClass » pour aider le pharmacien clinicien à...

LILLE (TICsanté) - Le logiciel "PharmaClass", qui utilise l'intelligence artificielle (IA), aide le pharmacien clinicien à sécuriser la prise en charge médicamenteuse à l'hôpital,...

Europe – EMA : Complex clinical trials – Questions and answers

This Q&A document provides guidance and seeks to support sponsors, clinical trialists and applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT...

Europe – EMA publishes annual report 2021

EMA’s annual report 2021 published today provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union...
NICE ‘OK’ for Lynparza

UK – NICE recommends Vazkepa for patients at risk of stroke and heart attacks...

Vazkepa is a new active substance, made up of a highly purified omega-3 fatty acid and is the first in this class to be...
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020

USA – Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests

Peter Marks, director of Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), attributes an increase in the...

International – Moderna announces trial results for new COVID-19 booster vaccine candidate

The analysis shows that the new vaccine offers better protection against Omicron than Moderna’s original vaccine, Spikevax, producing nearly double the neutralising antibody levels. The...

Europe – EMA adopts first list of critical medicines for COVID-19

On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of  critical medicines for the COVID-19 public health emergency . The medicines included in the...

USA – Cavazzoni: Pandemic-era tools, learnings are here to stay

The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Indian pharma to focus on quality to remain a world leader

The US Trade Representative (USTR) has questioned India for the country’s growing spurious medicine problem. According to the USTR report, nearly 20% of all...

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