News EU: Trials should include pregnant subjects where possible With new guidance, the EMA is seeking to ramp up the inclusion of pregnant and breastfeeding women in clinical trials.
News Autolus closes on EU okay for leukaemia cell therapy The CHMP backed approval of Autolus' leukaemia CAR-T Aucatzyl, as well as drugs from GSK, Roche, SpringWorks, and others, at its May meeting.
Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face
News Italfarmaco closes on EU okay for Duchenne drug Italfarmaco's oral HDAC inhibitor Duvyzat has been recommended for approval in the EU as a treatment for Duchenne muscular dystrophy (DMD).
Digital Leveraging data, digitalisation, and artificial intelligence... In an era marked by rapid technological advancements and evolving healthcare needs, the European Medicines Agencies Network Strategy 2028 stands as a key
News Lilly to appeal after CHMP rejects Alzheimer's drug Kisunla The CHMP has advised against EU approval of Eli Lilly's Alzheimer's drug Kisunla, potentially handing an advantage to Eisai/Biogen's rival drug.
News Remepy's hybrid Parkinson's therapy poised for phase 3 Remepy's Hybridopa therapy for Parkinson's, which combines an app with levodopa therapy, has shown efficacy in a phase 2 pilot study.
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