Europe – Reflection paper on the use of artificial intelligence in the lifecycle of...
EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation...
Europe – European Health Union: EU steps up action to prevent shortages of antibiotics...
The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency are today issuing recommendations for actions to avoid shortages of key antibiotics...
Europe – EMA statement on ongoing review of GLP-1 receptor agonists
EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists,1 including...
UK – Novavax COVID-19 vaccine produces immunity
Researchers leading the University of Oxford’s Com-COV3 study have delivered results from a study researching the immune response and side-effect profile of ‘mixed’ two-dose...
Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
Europe – Phasing out of extraordinary COVID-19 regulatory flexibilities
EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19...
Europe – Global regulators confirm good safety profile of COVID-19 vaccines
EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA).
Evidence from more than 13...
UK – BMS’ Sotyktu gets NICE green light for NHS use
The therapy becomes an option for moderate-to-severe plaque psoriasis in certain adults
Bristol Myers Squibb (BMS) has announced that the National Institute for Health and...
Europe – Guideline on clinical investigation of medicinal products in the treatment or prevention...
This guideline intends to address the current EU regulatory position on the main topics of the clinical development of new medicinal products in the...
UK – Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis
The new guidance specifically applies to patients with a Psoriasis Area and Severity Index score of ten or more, a Dermatology Life Quality Index...
