CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for a vaccine that is effective against the currently circulating strains of highly pathogenic avian influenza (HPAI). Innovax-ND-H5 (turkey herpesvirus, strain HVT-ND-H5 (cell-associated), expressing fusion protein gene of Newcastle disease virus and haemagglutinin gene of avian […]
Affecting over 500,000 people in the UK, IBD comprises Crohn’s disease and ulcerative colitis The study, published in Nature Immunology, could help identify new ways to treat inflammatory bowel disease (IBD). Collectively known as IBD, Crohn’s disease and ulcerative colitis are incurable conditions that involve excessive inflammation in the gut and affect over 500,000 people […]
The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2024. Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union […]
LDHA and GOT1 enzymes successfully targeted and halted energy production in hard-to-reach cancer cells Researchers from the Francis Crick Institute have revealed how cancer cells survive after being cut off from a supply of oxygen, which could potentially help prevent cancer from becoming resistant to therapy. Published in the EMBO Journal, the study revealed that […]
EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of postmenopausal bleeding. Postmenopausal bleeding is commonly defined as vaginal bleeding occurring one year or more after the last menstrual period. Postmenopausal bleeding is always considered abnormal and can be a symptom […]
In the UK alone, the aggressive form of cancer affects around 52,000 men every year Researchers from the University of Oxford and the University of Manchester have revealed that prostate cancer is not just a single disease and is made up of two different evotypes – subtypes of the disease. Published in Cell Genomics, the […]
CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for Alcort (hydrocortisole aceponate), from Nextmune Italy S.r.l., a new product for the alleviation of clinical signs associated with atopic dermatitis and for symptomatic treatment of inflammatory and pruritic dermatoses in dogs. The Committee adopted by […]
The platform delivers digitalised patient data to improve clinical trials and development Phesi has announced that its artificial intelligence (AI)-driven Trial Accelerator platform has reached a critical milestone of now containing global data from more than 100 million patients. The volume will allow sponsors to access data on patients with over 4,000 indications, plan more […]
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 are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the 3 months before conception. Valproate medicines are used to […]
Approximately one in five children will be hospitalised to treat measles The NHS has announced the launch of its new catch up campaign to get millions of children booked in for their missed measles, mumps and rubella (MMR) vaccine. The new campaign aligns with the health services efforts to protect children from becoming seriously ill […]
