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 – 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...
Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and...
This document is an annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use.
It contains a list of excipients with a known...
Europe – Global regulators call for international collaboration to integrate real-world evidence into regulatory...
EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International...
Europe – ICH Guideline M12 on drug interaction studies
This guideline provides recommendation to promote a consistent approach in designing,
conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies...
UK – NICE recommends Rhythm Pharmaceuticals’ Imcivree for severe obesity and hyperphagia
The recommendation follows positive results from clinical trials suggesting that Imcivree may reduce weight and body mass index (BMI) in people with obesity caused...
Europe – EC authorisation granted to kidney disease treatment Kinpeygo
The European Commission (EC) has granted conditional marketing authorisation for Kinpeygo (budesonide) capsules for the treatment of primary immunoglobulin A nephropathy (IgAN).
The treatment involves...
Europe – EMA validates application for Byondis’ trastuzumab duocarmazine
Byondis has announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for the company’s investigational next generation anti-HER2 antibody-drug...
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The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending a potentially life-extending treatment for a rare form of...
UK – NICE recommends Novartis’ Piqray in combination with Faslodex for advanced breast cancer...
The recommendation follows the ‘consistent, significant improvements’ in median progression-free survival and overall response rates when using Piqray in combination with Faslodex.
Breast cancer is...
