Merck Moved Every Japanese Keytruda Indication to a One-Minute Injection on a Single Lung Cancer Trial
One exposure trial in lung cancer carried every Japanese indication. The contest is now minutes and millilitres.
By therapy area
Telix Is Paying $1.65 Billion for ITM Without Handing the Sellers Any Cash at Closing
The sellers receive shares, not cash, at closing, and $450m of the $700m earnout rests on a single year of sales.
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.
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.
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.
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.