CDA-AMC reverses course, backs Leqembi’s first ruling content still undisclosed
Four words carry the news: follows a reconsideration. CDA-AMC reached a different conclusion first, and neither release says what it was.
Neurology
Teva Faces New Probe in Turkey Over Conduct Flagged by EU
Not a new theory of harm. It is the European Commission’s Copaxone decision run a second time, with two of the same corporate entities named.
Avulux Won a De Novo and Created the Category Its Competitors Will File Into
Going first through a De Novo builds the road behind you. Avulux owns the claim today and has created the category rivals will file 510(k)s into.
Roche Cleared an Alzheimer’s Blood Test With Three Result Categories. The Middle One Is Where PET Survives.
A three-way result means some patients resolve neither way, and those still go to imaging. Roche has not said how many land in the middle.
A Third Centiloid Scale Just Cleared. The First Two Already Disagree at the Threshold.
Cortechs.ai clears NeuroQuant PET for Centiloid amyloid quantification, entering a field where the two incumbent scales differ by more than 10 Centiloids.
The Effect Size Is 0.81. The Number That Decides the Business Is 6.4 Hours.
Effect size 0.81 settles the efficacy question. The number that decides the business is 6.4 hours of supervised monitoring per dose.
Logical Reasoning Survived Severe Aphasia, and Recruited No Language Regions in Healthy Brains
Two patients with severe aphasia solved formal logic problems as well as controls. The language network stayed quiet through both reasoning types.
The Year’s Two Largest Conjugate Deals Were Not ADCs, and Not Cancer Drugs
Buyers stopped paying for conjugate drugs and started paying for conjugate chemistry. The year’s two biggest cheques bought neither an ADC nor a cancer drug.
Tau does its damage inside mitochondria, independent of tangles and microtubules. The field’s imaging toolkit was built to see neither.
Tau does its damage inside mitochondria, independent of tangles and microtubules. The field’s imaging toolkit was built to see neither.
The FDA Approved Orzeyful and Handed the Approval Date to the DEA
FDA’s letter says the approval date is whenever the DEA publishes scheduling. Takeda holds a first-in-class approval it cannot sell yet.