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.
By technology
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 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.
Everyone’s New Pharma Lane Runs Through Heathrow
Two carriers built new pharma lanes in five weeks. Both end at Heathrow, an airport that lost a day to one transformer fire in March 2025.
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.
The First Phase 3 Win for an mRNA Cancer Therapy Arrives Without Its Numbers
The first Phase 3 win for an mRNA cancer therapy. Statistical significance was reported, effect size was not, and overall survival is still open.
Four Health Systems Automated the Prior Authorization Question, Not the Answer
The piece of the federal prior authorization mandate that shipped five months early is the piece that cannot deny anything.
Novartis Declines Canadian Reimbursement for Vanrafia Five Weeks After Health Canada Approved It
Health Canada cleared Vanrafia on a Week 36 proteinuria readout. Novartis will not take that same package into Canadian pricing review.