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.
Immunology & Inflammation
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.
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.
RiboX’s China Trial Data Bought It an Accelerated Dose Titration and a Subcutaneous Route
RiboX filed its Chinese investigator-initiated data with the IND. FDA granted faster escalation and a subcutaneous route on the strength of it.
Argenx’s $2.2 Billion Bought a Phase 1b With Ten Patients on Placebo
FB102’s entire human efficacy dataset in vitiligo is 42 patients, ten of them on placebo. argenx paid $2.2 billion in cash, with no milestones.
J&J Paid $785 Million for a Look at Something That Has Never Been in a Human
J&J committed $785 million including a $465 million equity stake, plus an option to acquire Sail Biomedicines for $2.58 billion, on a preclinical in vivo CAR-T platform.
AbbVie Took Two EU Approvals in One Day, Both for Diseases Payers Have Called Cosmetic
The European Commission approved RINVOQ for non-segmental vitiligo and, the same day, for severe alopecia areata, both in adults and adolescents aged 12 and over.