Roche Paid $190 Million Up Front on a $2.3 Billion Headline for a Phase 1 Obesity Asset
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Athithi Verma
FDA Moved a Class of Cancer Tests From PMA to 510(k). Fewer Than Five Parties Commented.
The order moves these tests from PMA to 510(k). One special control was deleted, and the predicate chain is where the change compounds.
Canada Moved Two Cancer Drugs Forward in One Week. Neither Went the Normal Route.
One drug reached review only because payers filed for a manufacturer that had not. The other was recommended on evidence the committee called inconclusive.
In Ustekinumab Biosimilars, Approval Stopped Being the Hard Part
A biosimilar licence used to be the scarce asset. In ustekinumab it is the entry ticket, and the returns go to whoever solves supply and device.
The Number Everyone Will Quote About European Launches Rests on Eleven Products
The 22.9% figure driving coverage of European launch delays is 48 products falling to 37. The pricing finding underneath it is stronger and barely quoted.
Singapore Approved Both Blenrep Combinations. Korea Reimbursed Only the One With Survival Data.
Same drug, same week, two Asian markets. The regulator approved on progression-free survival. The payer funded only the regimen with overall survival data.
A KAIST Barrier Chip Separated Three Glioblastoma Patients That MGMT Testing Called Identical
Three glioblastoma patients returned identical MGMT results and behaved differently on a barrier chip. The sample size is three, and the framing still matters.
Two FDA Device Authorisations, Two Sets of Evidence Narrower Than the Headline
Aletta matches human phlebotomists only when it agrees to attempt a draw. Narwhal cleared on bench and animal data, citing a trial with a different probe.
Two First-Ever Rare Disease Approvals Landed the Same Day. Both Were Measured by Proxy.
Pasatru’s flare benefit is clinician-assessed only. GENGLYCOS is indicated to reduce cornstarch intake. Two firsts, both measured a step from the patient.
A UC Irvine Team Names Five Mitochondrial Drug Classes for CAR-T Neurotoxicity and Says Nobody Is Testing Any of Them
Five mitochondrial drug classes named for CAR-T neurotoxicity, and the authors say none is under formal investigation. Every one is generic or preclinical.