UK – COVID-19 vaccines safe for pregnant women

The data revealed evidence of high levels of protection against SARS-CoV-2 infection in pregnant women after COVID-19 vaccination and evidence that vaccination induces higher...
Nitrosamine contamination: new web page on EDQM response

Europe – Évolution des délais de traitement des demandes de CEP par l’EDQM

Depuis le 1er octobre 2021, la Direction européenne de la qualité du médicament & soins de santé (EDQM) utilise un nouvel outil informatique pour gérer les demandes...

Europe – Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11....

Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as...

Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. EMA’s human medicines committee (CHMP) will assess the...

UK – NICE approves hormone drug which could prevent 1,200 miscarriages each year

NICE has issued an update to its guidance on threatened miscarriage which details that certain women can take progesterone to help prevent pregnancy loss....

Europe – A vision for use of real-world evidence in EU medicines regulation

Enabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe...

Europe – EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients...

EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). Lagevrio, which is being developed by Merck Sharp & Dohme...

UK – NICE recommends risdiplam for spinal muscular atrophy

NICE has published draft guidance recommending risdiplam (Evrysdi) as part of a managed access agreement (MAA) for the treatment of the rare genetic disorder...

Europe – PRAC recommendations on signals 25-28 October 2021 PRAC meeting

This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of...

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