NeuroPulse Wk 33: Jazz Bet $820M on a New FDA Evidence Standard
Jazz committed $820 million at signing for an epilepsy drug with one early trial behind it. The justification is a regulatory pathway, not the data.
NeuroPulse
Weekly neuro beat. The reach product.
NeuroPulse Wk 32: Takeda Fixed the Cause, and Cannot Ship It Yet
FDA approved the first medicine treating narcolepsy type 1 as a disease rather than a symptom set. Takeda cannot sell it for up to ninety days.
NeuroPulse Wk 31: An Open-Label 77% Could Not Rescue a Missed Endpoint
FDA told NeuroPace its generalized epilepsy expansion is not approvable as filed. An open-label 77% cannot rescue a randomized endpoint that missed.
NeuroPulse Wk 30: Three Orexin Programmes in Two Weeks
Lundbeck’s Fast Track makes three orexin programmes in two weeks. Plus a Duchenne filing with a January date, and a CHMP slip caused by a contract manufacturer.
NeuroPulse Wk 29: First Brain Link Shares Movement Between Two People
The Alzheimer’s Association International Conference drove the week’s pipeline news, but the signal that mattered most came from a lab: the first brain link that let one paralysed person move and feel through another. Around it, a tau target validated and contested in the same week, an oral entrant scaling in Huntington’s, and anti-amyloid therapy fighting its real battle, which is access.