Collaboration - December 11, 2013
Lundbeck and Otsuka to develop investigational vaccine candidate
H. Lundbeck and Otsuka Pharmaceutical today announced that they will further expand their collaboration to include the development of Lu AF20513, an investigational vaccine candidate for Alzheimer’s disease. Lu AF20513 is an anti-Aβ active vaccine candidate for Alzheimer’s disease which currently is in preclinical development. It is designed towards an optimal immunogenic response in the elderly, […]
Drug Development Pharma - November 25, 2013
European approval for Lundbeck and Otsuka
Lundbeck and Otsuka Pharmaceutical Co., Ltd. (Otsuka) have announced marketing authorisation approval from the European Commission for Abilify Maintena (aripiprazole). Abilify Maintena is an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole. “Studies have shown that the early use of long-acting injectables can prevent a person with schizophrenia […]
Collaboration - November 4, 2013
Otsuka named as Lundbeck’s partner in Japan on Nalmefene
Danish Lundbeck and Japanese Otsuka Pharmaceutical have announced that the companies’ existing alliance now also includes the development and commercialization of Nalmefene in Japan. Under the terms of the agreement, Lundbeck will receive an initial payment of EUR 50 million from Otsuka upon signing. Lundbeck will finance the development costs and has an option to […]
Drug Development Pharma - October 9, 2013
Takeda and Lundbeck announce FDA approval of Brintellix
Takeda Pharmaceutical Company and H. Lundbeck A/S jointly have announced that the U.S. Food and Drug Administration (FDA) has approved Brintellix (vortioxetine) for the treatment of adults with major depressive disorder (MDD). “MDD is a multifaceted disorder that encompasses emotional, physical and cognitive symptoms that may make it challenging to treat,” said Michael Thase, M.D., […]
Drug Development Pharma - September 25, 2013
Otsuka and Lundbeck receive positive CHMP opinion for Abilify Maintena(r) in schizophrenia
Lundbeck and Otsuka today announced a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for Abilify Maintena (aripiprazole), an intramuscular (IM) depot formulation for the maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. “Abilify Maintena has been available in the US for […]
Regulatory compliance - September 2, 2013
Lundbeck appeals EU decision
The Danish pharmaceutical group Lundbeck is appealing against the 93.8 million euros fine by the European Commission announced in June. Lundbeck was fined for deals with rivals to block the supply of generic versions of its citalopra anti-depressant to the market, a decision that was announced earlier this summer. In a press release, Lundbeck states that […]
