NICE Reversed on Enhertu Because the Threshold Moved, Not the Evidence
The clinical evidence did not change. NICE’s cost-effectiveness threshold did, as a term of a bilateral trade agreement.
By therapy area
Korea’s Reimbursement Delay Is a Staffing Problem, and the Ministry Said So
An industry association found the public agrees with industry. The news came later, from a division director naming headcount as the bottleneck.
The First Approval for Denecimig Came From Riyadh, Not Washington
One of the four Phase 3 studies is a safety-only switch from emicizumab. The commercial target was the incumbent, not the untreated.
ADCs Returned 0.46 in Relapsed Disease and 1.15 in the Front Line at WCLC
The dividing line is not the target or the payload. It is the setting: relapsed disease against chemotherapy, or the front line against chemo-IO.
Axon Targeting’s Switch Lives in the Cell Body Observed Here, Not Operated
Regeneration programmes can make axons grow. If targeting is transcriptional, growth was always the achievable half of a two-part problem.
NICE Withdrew Four Appraisals Because the Medicine Went Off Patent.
Going off patent now costs a medicine its named appraisal. And the withdrawal is a routing decision carrying no right of appeal.
Years After NCCN Recommended It, FET-PET Finally Has an FDA-Approved Drug
The clinical case was settled before the regulatory one. Clinicians held an NCCN recommendation with no lawful product to act on it.
CDA-AMC reverses course, backs Leqembi’s first ruling content still undisclosed
Four words carry the news: follows a reconsideration. CDA-AMC reached a different conclusion first, and neither release says what it was.
Biocon Makes It, a Consultancy Holds the Licence, and Sandoz Sells It
Three parties, three functions, and Biocon holds only the middle one. Treat the caretaker MAH structure as the Japanese default, not the exception.
Abbott Cleared the First Dual Glucose and Ketone Sensor. FDA Judged Accuracy, Not Admissions.
The label says diabetes. The clinical argument is type 1. Coverage conversations start from 2.1 million people, not 40.1 million.