One Missed, One Published the Arm That Failed, One Disclosed a Verb
Three Phase 3 toplines in one day, and the detail released runs inversely to the strength of the result. One company disclosed no number at all.
United States
CMS Projects: Fewer Losses and Bigger Savings. That Only Works If the Sick Are Removed.
CMS forecasts fewer disenrollments than CBO and higher savings. Both hold only if the people removed are the expensive ones, which means the sick.
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.
Lilly Can Sue the Sellers. It Can Only Ask the Payment Networks.
Six suits against small peptide sellers is not a strategy for a market spanning a hundred countries. It is a demonstration attached to an appeal.
Black Diamond Bought a Licence Instead of a Ruling, and Six Patents Stay Untested
These were not patents on a drug. They were patents on the methods used to find one, and Black Diamond has agreed to pay rather than test them.
Freenome’s Lung Test Is Indicated for People Who Never Show Up
Freenome defined its population by the failure of the existing pathway, not by anything measurable in the patient. That is the decision worth reading.
No Product Is Approved for Hernia Prevention. BD Is Spending Five Years to Change That.
BD is not testing a product against a competitor. It is testing whether an indication can be brought into existence, with no label, code or precedent.
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.
FastWave’s Pivotal Trial Cannot Measure the Thing FastWave Is Selling
Everything FastWave sells is comparative. The word its chief executive used is clearance, and clearance means substantially equivalent.
ITM’s Complete Response Letter Names No Clinical Concern. It Names a Third-Party Facility.
COMPETE hit its endpoint and is published in The Lancet. The FDA did not touch any of it. What stopped the approval is a facility ITM does not own.