Japan Clears Five Products in a Day, Two With a Price Cut Attached
Five approvals, one calendar date, one November pricing round. The two expansions are the ones the system taxes.
Topics
The CHMP Refused Nothing in September and Five Applications Were Pulled Anyway
Twelve approvals and no refusals. Apitegromab was cleared in the US on 11 September and pulled in Europe by the 17th.
Lilly’s New Combination Beats its Own Monotherapy
Median PFS doubled to 11.1 months against Inluriyo alone. The comparison payers will run is not in the package.
GENEROUS Signings Jump From Seven to 40 States in a Week
Forty states signed. Reporting last week put it at seven. The list CMS has never published is the manufacturers.
Korea Repriced 36 Fewer Items This Year and Took Out the Same ₩33.9 Billion
Thirty-six fewer items produced the same saving. Nothing about efficacy changed. The medicines that grew paid for it.
NeuroPulse Wk 38: Xenon Filed in Epilepsy and Paused in Psychiatry on the Same Day
The NDA and the enrolment pause went out in one release. Xenon says the events match the mechanism, not the indication.
OrphanPulse Wk 38: Two Untreatable Childhood Diseases Got First Therapies in 24 Hours
Seventeen treated children carried a gene therapy to standard full approval. Effect size did the work design could not.
Rare Disease Produced Two First-Ever Approvals in Two Days, and Both of Them Are Neurology
The FDA approved first-ever treatments for Sanfilippo syndrome type A and ataxia-telangiectasia a day apart. Both diseases destroy the nervous system.
Roche Paid $36.5 Million to Screen 300,000 Bispecific Combinations
Roche has not bought a molecule or a target. It has bought a search, and the pairing is an output rather than an input.
Novo’s $1.4 Billion Orbis Deal Does Not Say What It Paid at Signing
The headline has no denominator. Upfront and milestones are stated as one number, which makes the commitment impossible to assess.