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...
UK – MHRA introduces new restrictions for fluoroquinolone antibiotics
From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines...
UK – Pfizer’s Talzenna recommended by NICE for advanced breast cancer
Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable.
Additionally,...
Europe – Human medicines: highlights of 2023
The Agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and the first advanced therapy medicinal product using...
Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents...
UK – Pfizer’s COVID-19 antiviral Paxlovid recommended by NICE for expanded use
A further 1.4 million people with an increased risk for progression to severe COVID-19 will be eligible for Paxlovid following a positive test.
NICE already recommends the...
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 – EMA explains how tweaked Brexit deal will affect medicinal products
The European Medicines Agency (EMA) has answered nine questions on how the revised Brexit rules apply to centrally authorized medicinal products for human use...
