Neurology

Sales of spinal muscular atrophy drug Spinraza had an unexpected US boost in Q4 and Biogen may win US FDA approval for a high dose version this year, but Roche’s Evrysdi was just approved in a new tablet formulation.

Harness Therapeutics' CEO talked to In Vivo about the company's strategy for expansion and partnering in the neurodegeneration space.

GSK’s depemokimab, if approved, could become the first ultra-long-acting drug for treating asthma and chronic rhinosinusitis with nasal polyps. Meanwhile, Sanofi’s teplizumab, which the US approved as the first disease-modifying therapy for type 1 diabetes in 2022, has now been filed for review by the European Medicines Agency.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Stryker is selling its $700m spinal implants business to Viscogliosi Brothers, forming a new entity VB Spine, which will maintain a strong partnership with Stryker. The company also reported strong Q4 financials and announced a CFO transition.

Having spun out its oncology business and put all of its eggs into a neuroscience-shaped basket, how is Alkermes executing on its 2024 stated strategy to return to its CNS roots?

Boston-area start-up Axoft is developing a soft brain-computer interface device to help coma patients with covert consciousness communicate. Medtech Insight spoke with Axoft’s CEO Paul Le Floch about the technology, plans for first-in-human trials and potential future applications of the device to help patients with disorders of consciousness, including patients in a coma or vegetative state, communicate.

The European Medicines Agency wants to work with other regulators as well as industry, scientists and patients to “find solutions for the most pertinent problems in psychedelic research” and improve treatment options for psychiatric disorders more broadly, says the agency.

Low on cash when Pfizer handed back rights to its hemophilia A gene therapy, Sangamo is talking to partners for its Fabry disease gene therapy to fund its two lead programs through proof-of-concept.

Medtech Insight brings you the highlights from two panel discussions at CES 2025 featuring innovators in the neurotech space discussing opportunities, challenges and ethical considerations in developing AI-driven solutions for the brain, and what lies ahead.