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.
The Brief
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.
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.
NICE Wants Cosmetic Providers to Screen for BDD and Refer Rather Than Operate
Coverage will call this a mental health guideline. One recommendation reaches into a commercial market and tells its providers to turn business away.
ICER Priced Tavapadon Before the FDA Approved It or AbbVie Named a Price
An assessment body has priced a drug that has neither an approval nor a price. The number will sit in every payer negotiation that follows.