Europe – Finding clinical trials with the ACT EU Trial Map

In January 2024, the ACT EU Clinical Trials Analytics Workshop introduced a key deliverable: the integration of a map of clinical trials in the EU, with the CTIS...

UK – NICE recommends Gideon Richter’s Ryeqo as first daily pill for endometriosis

NICE has recommended in final draft guidance that the relugolix combination therapy be used on the NHS in England to treat the symptoms of...

UK – Merck KGaA’s Mavenclad tablets recommended by NICE for wider MS use

The health technology assessment agency has recommended in final draft guidance that the short-course oral therapy be used on the NHS as a first-line...

Europe – Commission proposes Critical Medicines Act to bolster the supply of critical medicines...

Today, the Commission has proposed a Regulation to improve the availability of critical medicines in the EU. The proposal aims to protect human health by incentivising supply...

Europe – EMA spells out data access policy for shortage monitoring platform

On Monday, the European Medicines Agency (EMA) issued a new data access policy, elaborating on the differing levels of data access available to different...

UK – Sobi receives NICE recommendation for Altuvoct in severe haemophilia A

Approximately 7,700 people in England are living with the genetic bleeding disorder and males are disproportionately affected. The condition results from insufficient levels of functioning...

Europe – New clinical trial map launched in the EU

A new clinical trial map is now accessible from the public website of the Clinical Trials Information System (CTIS). The map is designed to provide patients...

Europe – First topical gene therapy treatment for dystrophic epidermolysis bullosa

EMA has recommended granting a marketing authorisation in the European Union (EU) for Vyjuvek (beremagene geperpavec) to treat wounds in patients of all ages with dystrophic epidermolysis...

Europe – Combination of cystic fibrosis medicines to treat patients with rare mutations

EMA’s human medicines committee (CHMP) has recommended extending the therapeutic indication of two medicines, Kaftrio (ivacaftor / tezacaftor / elexacaftor) and Kalydeco (ivacaftor) for the treatment of...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – mRESVIA RSV vaccine approved to protect patients aged 60 and over

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to protect patients aged...

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