The Measurement Problem Behind Two Decades of Neurology Trial Failures
The FDA now treats continuous, real-time data sharing as a regulatory direction of travel rather than a theoretical future. The neurology field should pay close attention.
The FDA now treats continuous, real-time data sharing as a regulatory direction of travel rather than a theoretical future. The neurology field should pay close attention.
French startup Naox Technologies this month became the first company to receive FDA 510(k) clearance for an in-ear EEG device. The system seeks to improve care for neurological conditions like epilepsy, Alzheimer’s and sleep disorders by capturing brain activity in everyday settings that traditional scalp-based EEGs often miss.
With new therapies being approved, and many others in the pipeline, they raise a critical question: Is our healthcare system prepared to deliver them effectively and sustainably?
Specific targets were not disclosed, but Merck KGaA is betting the artificial intelligence technologies of Exscientia and BenevolentAI will discover new drugs for cancer, neurology, and immunology.
Rapport Therapeutics, a clinical-stage biotech that was founded last year, raised $150 million in Series B financing, bringing its total funding to date to $250 million. The company's platform leverages receptor-associated proteins to create neurology drugs that have more focused activity in the brain, going after disease-driving circuits and cell types.
GrayMatters Health recently received 510(k) clearance from the FDA to market its flagship product, which is a self-neuromodulation digital therapy for PTSD. The device uses neurofeedback on specific biomarkers to help patients identify and utilize their own mental strategy for lowering their emotional response.
Red Tree Venture Capital has closed a $272 million fund focused on investing in West Coast life sciences companies. The firm’s founders say they’re filling a need by providing financial support for innovations emerging from the region’s academic labs.
Memory Health CEO Edward Shehab talked about taking a preventive approach to neurodegenerative conditions.
The financing round was led by Concord Health Partners, with AlbaCore Capital Group and Hambro Perks also contributing. The latest haul follows a $125 million raise that the company announced in October.
Nines received 510(k) clearance for a system that monitors CT scans for likely cases intracranial hemorrhage and mass effect, two conditions associated with strokes. The system prioritizes these cases for review from radiologists, letting patients receive a diagnosis faster.
Insightec, a company making an ultrasound device that can be used to treat essential tremor, raised $150 million. The company now has a post-money valuation of $1.3 billion.
Alder, based in a suburb of Seattle, has a monoclonal antibody that it has investigated as a treatment for migraine and is under FDA review, with the agency expected to decide on its approval in February of next year. Shares of Alder were up 83 percent on the news.
While well-developed in cancers, precision medicine's readiness for prime time beyond oncology varies markedly from disease to disease. But reimbursement remains a significant hurdle.
The trial's primary endpoint will be one for which the drug, OV101, produced encouraging but mixed results in a Phase II study of patients with Angelman syndrome.