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...
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In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated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...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa), for...
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...
