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.
CI read
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.
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.
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.
The First Approval for Denecimig Came From Riyadh, Not Washington
One of the four Phase 3 studies is a safety-only switch from emicizumab. The commercial target was the incumbent, not the untreated.
The UK Commission Wants L-Plates for AI and an End to One-Time Approval
Coverage is calling these new AI rules. What they propose is replacing the single approval decision with supervised entry and permanent monitoring.
Biocon Makes It, a Consultancy Holds the Licence, and Sandoz Sells It
Three parties, three functions, and Biocon holds only the middle one. Treat the caretaker MAH structure as the Japanese default, not the exception.
A Jury Convicted the Philips Engineer. The Approach Came as His Plant Was Closing.
The approach came in 2017 as Philips prepared to close the plant. A site closure is a knowledge event before it is a cost event.
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.