MHRA Puts Microbiome Medicines Inside the Existing Framework While the EU Builds a Separate One
No bespoke regime is coming. Microbiome medicines meet the standard biological bar in the UK, while the EU builds a separate SoHO framework.
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PDUFA VIII Keeps Every Review Clock and Hires Four Auditors
Industry renegotiated what it pays FDA without changing what it gets. The clocks held. What expanded is the apparatus for verifying the money buys reviewers.
A Third Centiloid Scale Just Cleared. The First Two Already Disagree at the Threshold.
Cortechs.ai clears NeuroQuant PET for Centiloid amyloid quantification, entering a field where the two incumbent scales differ by more than 10 Centiloids.
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.
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.
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.