Europe – Products Management Services (PMS) – Implementation of International Organization for Standardization (ISO)...
The EMA intends to migrate the Centrally Authorised Products (CAPs) and non-Centrally Authorised Products (non-CAPs) data held in the eXtended Eudravigilance Medicinal Product Dictionary...
UK – Sobi receives NICE recommendation for Zynlonta in two non-Hodgkin lymphomas
The CD19-directed antibody-drug conjugate (ADC) has specifically been recommended for use in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade...
Europe – Clinical trials’ transition to new EU system – one year left
All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks...
Europe – Experts outline challenges of combination products in Europe
Combination products are increasingly important, increasingly complex and are increasing the pressure on the European regulatory network, according to Thomas Wejs Møller, senior director...
Europe – Precautionary measures to address potential risk of neurodevelopmental disorders in children born...
On 24 January 2024, the CMDh1 endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Three new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
The committee recommended granting a marketing...
Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine...
This medicine is used for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘nonsense...
Europe – EMA confirms measures to minimise the risk of serious side effects with...
PRES and RCVS are rare conditions that can involve reduced blood supply to the brain, potentially causing serious, life-threatening complications. With prompt diagnosis and...
UK – NICE recommends two AI-powered software tools for stroke diagnosis in NHS
The two softwares – e-Stroke and RapidAI – were selected after the health technology assessment agency found some evidence of faster and better access...
Europe – User guide for micro, small and medium-sized enterprises
This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...
