Europe – AbbVie’s Rinvoq granted NICE recommendation as ulcerative colitis treatment
The recommendation is specifically for adults with the immune-mediated inflammatory bowel disease, for whom conventional or biologic treatments cannot be tolerated, or for those...
Europe – Global regulators agree on way forward to adapt COVID-19 vaccines to emerging...
International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition...
Europe – EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS...
The European Union’s proposed restriction on the use of per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” would have grave implications on...
Europe – EMA recommends approval of Imvanex for the prevention of monkeypox disease
EMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease.
The medicine has been approved in the EU...
UK – Kidney Cancer UK receives commission from NICE
The charity Kidney Cancer UK has, through its approach to NHS England, secured a commission for the National Institute for Health and Care Excellence...
Europe – EMA : Complex clinical trials – Questions and answers
This Q&A document provides guidance and seeks to support sponsors, clinical trialists and
applicants regarding scientific aspects and the planning, set-up, submission for obtaining CT...
UK – NICE issues final draft recommending Novartis’ Scemblix to treat chronic myeloid leukaemia
NICE’s decision will allow access to an innovative treatment channel which will help to address an unmet need for eligible people in England and...
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 – ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for...
EMA’s Emergency Task Force (ETF) considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for primary...
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...
