International – International regulators and WHO: support healthcare professionals to enhance public confidence in...

EMA has endorsed a statement for healthcare professionals jointly developed by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). The statement is aimed...

France – Cegedim Santé lève 65 millions d’euros et acquiert l’entreprise de télémédecine MesDocteurs

PARIS (TICsanté) - Le groupe Cegedim a annoncé le 16 mai avoir signé un "protocole d'investissement" avec les groupes de protection sociale Malakoff Humanis,...

UK – NICE recommends AstraZeneca’s Imfinzi for adults with non-small cell lung cancer

The regulatory approval is specifically for adults whose tumours present a protein called PD-L1 on at least 1% of tumour cells and whose disease...

USA – FDA works to advance real-world data collection in pregnancy and lactation

The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – Pandemic highlighted challenges of ATMP clinical trials in Europe

A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19...

UK – NICE draft final guidance for Gedeon Richter UK’s new uterine fibroids treatment

Around 4,500 people in the UK will be eligible for a new oral treatment for uterine fibroids. It follows the National Institute for Health...

USA – FDA guidance explains benefit-risk approach for quality assessments

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of...

USA – FDA launches program to speed up rare disease drug development

FDA announced on May 10, 2022 that its Center for Drug Evaluation and Research (CDER) has launched a new program to increase and speed...

Europe – COVID-19 vaccines safety update

The safety of authorised COVID-19 vaccines is continuously monitored and updated information is regularly provided to the public. Safety updates outline the outcomes from assessments...

Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of...