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...
USA – Experts propose restricting trademarks on accelerated approval drugs to speed confirmatory trials
Manufacturers might be incentivized to speed up completion of confirmatory trials for their accelerated approval drugs if they are restricted from using a brand...
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...
Canada – Submitting risk management plans guidance document: Overview
This guidance document on submitting risk management plans, published on February 24, 2025, will come into effect on July 1, 2025.
In the meantime the Guidance...
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...
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...
Europe – Clinical investigation of medicinal products in the treatment of patients with acute...
The aim of the guideline is to provide guidance for the development of medicinal products for the treatment of Acute Respiratory Distress Syndrome (ARDS)...
