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.
Immunology & Inflammation
Latvia Squeezes Access for 123,000 Patients Out of Price Deals as 124 Drugs Wait
Latvia is buying access with manufacturers’ money, inside a reimbursement budget NVD already expects to overrun.
Novartis $7.8 Billion Abogen Bet Rests on Efficacy Data From Three Patients
Up to $7.8 billion for an mRNA engager with efficacy data from three patients, 32 days after Novartis halted its CAR-T.
Sanofi Pays Regeneron $1 Billion to Keep Dupixent’s Successors Inside a 23-Year Alliance
Sanofi is paying to keep Dupixent’s next generation in the partnership, and the deal also closes a lawsuit between them.
Roche Claims Best-in-Class Potential for Sefaxersen Without Disclosing How Much It Cut Proteinuria
Sefaxersen hits the same target as Novartis’s Fabhalta. Roche withheld the one number that would show which drug does more.
Roche Paid $36.5 Million to Screen 300,000 Bispecific Combinations
Roche has not bought a molecule or a target. It has bought a search, and the pairing is an output rather than an input.
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.
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.