UK – NICE recommends Eli Lilly’s breast cancer therapy
Eli Lilly has announced that Verzenios – also known as abemaciclib – in combination with endocrine therapy, has been recommended by the National Institute...
Europe – EMA recommends restricting use of cancer medicine Rubraca
EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian...
Europe – High-quality data to empower data-driven medicines regulation in the European Union
EMA and the Heads of Medicines Agencies (HMA) in the EU Member States are moving ahead with their ambitious agenda to increase access and improve the...
Europe – EMA offers insights on when biologics qualify as new active substances
The European Medicines Agency (EMA) is looking for feedback on a draft reflection paper that lays out its criteria for determining whether biological substances...
UK – Roche’s Polivy recommended by NICE for lymphoma therapy
In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse...
UK – NICE approval for Janssen’s Darzalex combination
Recommendation concerns routine use across the NHS as therapy for multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the National...
UK – G7 health ministers unite to protect world from another pandemic
Commitments also made on tackling antimicrobial resistance (AMR) – a global killer costing millions of lives a year
Focus on climate and health...
UK – NICE issues final appraisal recommending LEO Pharma’s Adtralza for moderate-to-severe atopic dermatitis
The recommendation is specifically for adult patients with the condition who are eligible for systemic treatment, only if the disease has not responded to...
Europe – ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement providing updated public health considerations on the...
Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
EMA’s safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was...
