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Neurology
Sage will end development for dalzanemdor after it failed in a Phase II Huntington’s disease trial, leaving the company with one commercial drug and three early-stage assets.
Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.
Patients in the ICU continue to die from SARS-CoV-2-induced acute respiratory distress syndrome, says InflaRx, which is one of companies whose product the European Medicines Agency today announced should be approved for marketing in the EU.
After an initial rejection, the European Medicines Agency now says that Eisai/Biogen’s Alzheimer’s disease drug should be approved, albeit with a recommendation for initial generic screening and ongoing safety scans.
Trace Neuroscience will take its antisense oligonucleotide that restores UNC13A protein production through proper mRNA splicing into the clinic in early 2026.
The European Medicines Agency’s human medicines committee is meeting this week due to decide whether or not to back pan-EU marketing approval for a number of new drugs.
Patient representatives are due to have their say today at a high-stakes meeting at the European Medicines Agency, which, after re-examining its previous rejection of Leqembi, is expected to deliver its final decision on whether the drug should be approved for marketing in the EU.
Octave Bioscience’s CEO Doug Biehn sat down with Medtech Insight at HLTH to talk about the company’s plans for expanding their multivariate biomarker blood test for MS analysis and development of a diagnostic for Parkinson’s disease.
Eisai/Biogen’s Alzheimer’s disease medicine Leqembi has been a challenge to launch, but while access to pre-treatment testing has improved, infusion center capacity is impacting US sales.
Q3 sales of DMD gene therapy Elevidys beat forecasts, but the company declined to raise Q4 and 2025 guidance. It plans to file a second gene therapy with the US FDA next year.