UK – Amvuttra recommended by NICE for amyloidosis
Alnylam has welcomed a draft decision from the National Institute for Health and Care Excellence (NICE) recommending the use of Amvuttra on the NHS...
UK – NICE recommends wider use of statins to cut risk of heart attack...
Up until now, NICE has recommended that those with a 10% or higher risk over ten years of a cardiovascular event should be offered...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 – 12...
Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors
EMA’s safety committee, PRAC has further reviewed measures to minimise the risk of serious...
International – ICH guideline Q13 on continuous manufacturing of drug substances and drug products
This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It is applicable to CM for new...
UK – AstraZeneca/Daiichi Sankyo’s Enhertu recommended by NICE for advanced breast cancer
The recommendation follows updated results from the DESTINY-Breast03 phase 3 trial, announced by the companies earlier this month, in which Enhertu demonstrated a statistically...
UK – Sanofi Pasteur COVID-19 vaccine authorised by MHRA
VidPrevtyn Beta, the COVID-19 vaccine developed by Sanofi, has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It becomes the seventh COVID-19...
UK – Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment recommended by NICE
The final draft guidance issued by NICE means that patients will be eligible to receive the antifibrotic treatment, which is currently recommended for patients...
Europe – Facilitating Decentralised Clinical Trials in the EU
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs)...
Europe – EMA recommendation paper: Safety, data integrity key to decentralized trial conduct
The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently acknowledged the growing role of decentralized elements in the...
Europe – First gene therapy to treat haemophilia B
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene dezaparvovec) for the treatment of severe and moderately severe haemophilia...
