Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8.

The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded.

Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8.

Nippon Shinyaku Co. Ltd.’s NS-035 has been awarded Japanese orphan drug designation for the treatment of Fukuyama congenital muscular dystrophy.

J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment.

J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment.

Takeda Pharmaceutical Co. Ltd.’s oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb Co.’s first-in-class Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout of moderate to severe plaque psoriasis.

Immunomic Therapeutics Inc. has obtained clinical trial notification (CTN) clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for ITI-9001, an investigational immunotherapy for Japanese red cedar allergy. The first-in-human phase I trial will begin in Japan in the second quarter.

Takeda Pharmaceutical Co. Ltd.’s oral TYK2 inhibitor zasocitinib (TAK-279) demonstrated statistical superiority over Bristol Myers Squibb Co.’s first-in-class Sotyktu (deucravacitinib) in a top-line phase III Latitude Atlas readout of moderate to severe plaque psoriasis.

Japan has granted marketing approval to Oncolys Biopharma Inc.’s oncolytic adenovirus product, Telomelysin (suratadenoturev, OBP-301), for treating esophageal cancer in patients who are not eligible for curative resection or chemoradiotherapy. The approval marks the first oncolytic adenovirus product approved for esophageal cancer.