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Latest From Eisai Co., Ltd.

EU Blow For Alzheimer’s Drug Leqembi; Eisai To Appeal

The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe is hoping that real-world findings from the US-mandated patient registry or from ongoing trials will help persuade the EU regulator to reconsider its position.

Drug Review Approvals

Digital Health Roundup: Brain Talk On Seizures, Alzheimer's, Stress, Anxiety; Medtronic's OR Report; Health Care AI; UK Guidances

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights AI discussions at the HLTH Europe conference and an interview with Motif Neurotech's CEO Jacob Robinson. Elizabeth Orr discusses DeepWell DTx's newly launched VR game for treating stress-related hypertension and anxiety. Natasha Barrow provides an overview of Digital Mental Health Technologies regulation in the UK and Brian Bossetta reports ‘the good and bad’ from Medtronic's report on digital technologies' use in the operating room. 

Digital Health Roundup Digital Health

EU Moment Of Truth For Lecanemab & 14 Other Drugs

Eisai/Biogen could this week learn whether the European Medicines Agency will give the thumbs up to market lecanemab across the EU for early Alzheimer’s disease.

Europe Drug Review

EMA Backs New Method For Measuring Alzheimer’s Disease In Trials

Evidence generated through an EU public-private funding initiative has resulted in a new biomarker method for measuring the level of Alzheimer’s disease in a person’s brain, which drug developers can use during clinical trials.

Europe EU
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