Jaypirca’s 80% Win Over Chemo Opens a First-Line CLL Fight With Three BTK Rivals
Jaypirca reaches first-line CLL on a win over chemo, and now has to take share from three covalent BTK inhibitors.
FDA Approval
AbbVie’s Juvmo Won FDA Approval Three Days Before ICER Holds a Public Meeting on Its Value
AbbVie now has to name a price for Juvmo into a benchmark that ICER set before the drug was even approved.
FOP Now Has Three Approved Drugs for About 300 US Patients, Two of Them in 37 Days
Three drugs now divide an ultra-rare disease by mechanism, route and age, and the newest competes on convenience and safety.
Lilly’s New Combination Beats its Own Monotherapy
Median PFS doubled to 11.1 months against Inluriyo alone. The comparison payers will run is not in the package.
NeuroPulse Wk 30: Three Orexin Programmes in Two Weeks
Lundbeck’s Fast Track makes three orexin programmes in two weeks. Plus a Duchenne filing with a January date, and a CHMP slip caused by a contract manufacturer.
J&J Built Its Surgical Robot Into the Table, and Aimed It at the 92% of Surgery That Isn’t Robotic
The FDA granted De Novo authorization to OTTAVA, the first surgical robot with arms built into the operating table, cutting the footprint by up to half.
Benlysta Autoinjector Approval Transforming Pediatric Lupus Nephritis Management
GSK’s Benlysta autoinjector gains FDA nod for pediatric lupus nephritis, enabling at-home treatment.