Europe – EMA reviewing data on sabizabulin for COVID-19
EMA’s Emergency Task Force (ETF) has started a review of data on the use of sabizabulin for treating COVID-19.
The review will look at all available...
Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
UK – MHRA updates biosimilar guidance to allow interchangeability between products
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if they use...
Europe – EMA Management Board: highlights of June 2023 meeting
The European Commission informed the Board about its legal proposals to revise the pharmaceutical legislation, published on 26 April, which aim to make the...
UK – AstraZeneca’s heart failure treatment recommended by NICE for expanded use
Forxiga, sold as Farxiga in certain markets, has previously been recommended by NICE as a treatment option for HF patients with reduced ejection fraction...
Europe – First version of the Union list of critical medicines agreed to help...
The list is an important tool to support the EU’s efforts in ensuring supply security and preventing shortages of critical medicines. Inclusion in the...
Switzerland – Déclarations d’effets indésirables présumés de vaccins contre le COVID-19 évaluées en Suisse
Depuis le rapport standard final sur les déclarations d’effets indésirables présumés des vaccins COVID-19 évaluées en Suisse de fin février 2023, 720 déclarations ont été évaluées....
Europe – Report: How EU ensured safety of medicines during COVID-19
Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders...
Europe – Potential risk of neurodevelopmental disorders in children born to men treated with...
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines. These measures are to address a potential...
Europe – Guidance on paediatric submissions
The following guidance outlines the main steps to take to prepare for submission, and a list of documents required for the main1 types of...
