EC approves Otsuka and Lundbeck’s Rxulti for schizophrenia
The decision was supported by a randomised, six-week, placebo-controlled trial involving 316 adolescent subjects.
The Pharma Letter1d
Rxulti now approved for adolescents in Europe
The European Commission (EC) has approved Danish CNS specialist Lundbeck (LUND: CO) and Otsuka Europe’s Rxulti ...
PharmaTimes1d
Rxulti approved in the European Union for adolescent schizophrenia
Otsuka Pharmaceutical Europe and Lundbeck have announced that the European Commission has approved Rxulti (brexpiprazole) for ...
Lundbeck’s amlenetug gains orphan drug status in Japan for MSA
Amlenetug is tailored to attach to all major extracellular α-synuclein forms. The human monoclonal antibody aims to prevent ...
Pharmabiz4d
Lundbeck’ amlenetug receives Japanese orphan drug designation for treatment of multiple system atrophy
Lundbeck’ amlenetug receives Japanese orphan drug designation for treatment of multiple system atrophy: Denmark Tuesday, March 11, 2025, 11:00 Hrs [IST] H. Lundbeck A/S (Lundbec ...
H. Lundbeck A/S: Lundbeck's potential treatment for Multiple System Atrophy granted Orphan Drug Designation in Japan
The Ministry of Health, Labor, and Welfare (MHLW) in Japan has granted Orphan Drug Designation (ODD) to Lundbeck's investigational drug, amlenetug ...
H. Lundbeck A/S: Rxulti (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older
Brexpiprazole's indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older1Approval follows a positive Committee for Medicinal Products ...
news.bloomberglaw24d
Otsuka, Lundbeck Sue Alvogen to Block Copies of Abilify Maintena
Alvogen Inc.’s proposed generic version of Abilify Maintena infringes six patents for the schizophrenia treatment that an Otsuka Holdings Co. unit exclusively licenses to H. Lundbeck A/S, a federal ...