Neurology

Several new drugs that are yet to be approved anywhere in the world are now under review by the European Medicines Agency for potential pan-EU marketing authorization.

Vertex has the first-in-class NaV1.8 inhibitor for acute pain, Journavx, but Latigo plans to bring forward multiple best-in-class options for acute and chronic pain against NaV1.8 and other targets.

The Australian Therapeutic Goods Administration proposed a narrower indication that Eisai rejected.

A joint venture with AI specialist Hologen will bring in much-needed cash for the ambitious gene therapy firm.

Cost and evidence gaps remain barriers for Kisunla and Leqembi as NICE rejects the drugs again but opens further consultations on the reimbursement of the Alzheimer's disease-modifying treatments.

Companies are exploring new mechanisms of action beyond traditional amyloid and tau and both investors and big pharma are willing to make deals when the science is compelling, panelists at Biotech Showcase said.

The European Medicines Agency is considering whether apitegromab, brensocatib and diazoxide choline, from Scholar, Insmed and Soleno respectively, are drugs that are of potential major public health interest, particularly from the point of view of therapeutic innovation.

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.