UK – Novartis’ Cosentyx recommended by NICE for hidradenitis suppurativa
The recommendation, which makes Cosentyx the first biologic treatment for HS since 2016, specifically applies to patients who have had an inadequate response to...
Europe – EMA takes further steps to address critical shortages of medicines in the...
Today, EMA published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to...
Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic...
The European Medicines Agency has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution...
UK – NICE recommends Roche’s Columvi for advanced lymphoma in UK
The National Institute for Care and Excellence (NICE) has recommended Roche’s Columvi (glofitamab) for NHS use as a treatment option for a type of...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2023 meeting.
The CHMP adopted a positive opinion for Agamree* (vamorolone),...
UK – Guidance : Full pack dispensing of valproate-containing medicines
This is guidance for dispensing of valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs). These amendments...
Europe – Convergence: EMA official urges transition of existing clinical trials to CTIS portal
Sponsors should plan to transition existing clinical trials into the new Clinical Trial Information System (CTIS) portal by 30 January 2025, Anabela Marcal, of...
Europe – EMA Management Board: highlights of October 2023 meeting
EMA’s Management Board met on 5 October in Amsterdam.
Clinical trials in the EU
The Board adopted revised transparency rules for the publication of information on clinical...
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 – 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...
