Europe – New medicine to protect babies and infants from respiratory syncytial virus (RSV)...
EMA has recommended a marketing authorisation in the European Union (EU) for Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease...
UK – NICE publishes draft guidance recommending three COVID-19 treatments
The treatments recommended by NICE are Roche’s RoActemra (tocilizumab) and Eli Lilly’s Olumiant (baricitinib), both indicated for use in a hospitalised setting in patients...
Europe – EMA recommends approval of second adapted Spikevax vaccine
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the...
Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 5.6% as of 3 October 2022, to reflect the inflation rate...
Europe – Review of pholcodine medicines started
The European Medicines Agency (EMA) has started a review of medicines that contain pholcodine following concerns that their use may put people at risk...
UK – Bristol Myers Squibb’s Opdivo recommended by NICE for malignant pleural mesothelioma patients
The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending a potentially life-extending treatment for a rare form of...
USA – Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver
The World Trade Organization’s (WTO) agreement to a partial patent waiver for COVID-19 vaccines “sends a dangerous signal” to the pharmaceutical industry and all...
UK – NICE recommends Alexion’s asfotase alfa across England
Alexion Pharma’s asfotase alfa – also known as Strensiq – has been recommended by the National Institute for Health and Care Excellence (NICE) for...
Europe – EMA Procedural Advice on Recommendations on unforeseen variations according to Article 5...
Article 3 paragraph 1 of Commission Regulation (EC) No 1234/2008 (Variation Regulation) refers to Annex II where a classification of minor variations, type IA...
France – Gustave-Roussy choisit Synapse Medicine pour sécuriser ses prescriptions complexes
VILLEJUIF (Val-de-Marne), BORDEAUX (TICsanté) - Le centre de lutte contre le cancer Gustave-Roussy a noué un partenariat avec l'entreprise bordelaise Synapse Medicine, qui développe...
