AbbVie’s Skyrizi Combination Nearly Doubled Endoscopic Remission at 24 Weeks in Crohn’s, in an Open-Label Study Without Placebo
The gap over Skyrizi widened from week 12 to week 24, the stronger signal in an open-label study without placebo.
Clinical Read
NICE Wants Cosmetic Providers to Screen for BDD and Refer Rather Than Operate
Coverage will call this a mental health guideline. One recommendation reaches into a commercial market and tells its providers to turn business away.
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.
Trodelvy Now Covers First-Line TNBC Across PD-L1 Status. The Two Regimens Are Not Equally Tolerated.
Serious adverse reactions ran at 38% in the combination trial against 26% in the monotherapy trial. Same drug, same line, different companion.
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.
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.
MoonLake Says IZAR-1 Met Every Endpoint and Will Not Show You the Placebo Arm
MoonLake disclosed 42.1% ACR50 and withheld the placebo arm. An absolute response rate without a comparator is a number, not a result.
Replimune Won Accelerated Approval on 91 Evaluable Patients and a 24% Response Rate
CBER took a 24% response in 91 evaluable patients, one day after the same committee voted nine to three against Capricor. Measurement, not size.
An FDA Panel Voted 9-3 Against Capricor on Cardiomyopathy and Never Voted on the Endpoint That Passed
The ballot was the outcome. A drug’s strongest dataset sitting off the voting question is not a footnote, it is the whole result.
A B7-H3 Antibody Drug Conjugate Just Won a Second Phase 3, in a Second Tumour
A second positive Phase 3 in a second tumour makes Ris-Rez the only B7-H3 antibody-drug conjugate with late-stage wins across more than one cancer.