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...
USA – Legislation could catalyze EU pharma industry innovation
The EU pharmaceutical industry has warned that the bloc is lagging behind when it comes to innovation and losing its position in the global...
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The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending a potentially life-extending treatment for a rare form of...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...
Europe – EMA re-elected as chair of ICMRA from October 2022
The International Coalition of Medicines Regulatory Authorities (ICMRA) today elected Emer Cooke, Executive Director of EMA as chair for the next mandate which starts in...
International – Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines
Infectious disease experts from Asia reviewed data from the VIEW-hub database on vaccine use and impact, developed by John Hopkins Bloomberg School of Public...
USA – Guidance : Instructions for Use — Patient Labeling for Human Prescription Drug...
This guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological...
USA – HHS issues guidance on legally prescribed drugs for abortion
The Biden administration on Wednesday said retail pharmacies and pharmacists must provide patients with the medication they were legally prescribed even if it could...
