FDA grants Priority Review to Takeda’s zasocitinib after Phase 3 psoriasis studies, including head-to-head superiority versus deucravacitinib.
Takeda Pharmaceutical Company Limited has secured United States Food and Drug Administration approval for ORZEYFUL, or oveporexton, the first oral orexin receptor 2 agonist authorised to treat narcolepsy type 1 as a complete disorder in adults. The approval introduces a new treatment mechanism, but the medicine will not become available until the Drug Enforcement Administration
Fresenius advances PB016 into FDA and EMA review, but competition, manufacturing scrutiny and IV-only positioning will shape its launch path.
Lundbeck’s Lu AH69593 gains FDA Fast Track status, but its Phase 1 narcolepsy programme enters an increasingly competitive orexin field.
Takeda plans a $30 million Indonesia plasma network as local manufacturing stays under review. See what the deal changes for medicine access.
Find out how Takeda’s oveporexton data could reshape narcolepsy type 1 care as approval, safety and access questions loom.
Find out how Takeda’s pediatric Entyvio review could change biologic treatment choices in ulcerative colitis and Crohn’s disease.
Autonomous labs can run experiments faster. The bigger shift is what happens when biopharma researchers stop executing and start directing.
Takeda’s zasocitinib posted strong Phase 3 psoriasis data. Read what it changes for TYK2 competition, regulation, and oral treatment strategy.
Takeda Pharmaceutical Company Limited has reported positive topline results from two pivotal Phase 3 studies of its investigational drug zasocitinib (TAK-279), a once-daily oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis. The trials met all primary and secondary endpoints, with more than 50 percent of participants achieving near-complete skin clearance (PASI