Otsuka Pharmaceutical Co., Ltd.
2-9 Kanda Tsukasa-cho
205 articles with Otsuka Pharmaceutical Co., Ltd.
Otsuka and Lundbeck Announce FDA Acceptance and Priority Review of sNDA for Brexpiprazole for the Treatment of Agitation Associated With Alzheimer’s Dementia
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce the U.S. Food and Drug Administration has determined that the supplementary New Drug Application for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia is sufficiently complete to permit a substantive review.
Mindset Pharma was granted allowance by the U.S. Patent and Trademark Office for its application for a psilocybin-based family of drugs to treat central nervous system disorders.
Otsuka and Lunbeck report positive Phase III results in agitation in Alzheimer's, Acer's vEDS program hits Phase III and BridgeBio's primary hyperoxaluria type 1 program progresses.
Otsuka Pharmaceutical terminated a deal with Akebia Therapeutics, which ends the U.S. and ex-U.S. vadadustat Collaboration and License Agreements.
Otsuka Pharmaceutical and Lundbeck announced positive Phase III clinical trial results Monday regarding brexpiprazole (Rexulti) as a treatment for agitation in patients with Alzheimer’s dementia.
CORRECTING and REPLACING Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer’s Dementia Treated with Brexpiprazole
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce positive results of the Phase 3 clinical trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia.
Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer’s Dementia Treated with Brexpiprazole
Results from a Phase 3 clinical study for treatment of agitation in patients with Alzheimer’s dementia showed that patients treated with brexpiprazole had a statistically significantly greater reduction in agitation compared to placebo.
Akebia Therapeutics’s partner Otsuka Pharmaceutical Co. announced plans to terminate its global license agreements with Akebia for vadadustat.
Bristol Myers Squibb’s Phase III CheckMate -816 trial hit the primary endpoint in an interim analysis.
Akebia Announces Otsuka's Submission of Initial Marketing Authorization Application to the European Medicines Agency for Vadadustat for the Treatment of Patients with Anemia due to Chronic Kidney Disease
Akebia Therapeutics, Inc and its collaborator, Otsuka Pharmaceutical Co., Ltd. (Otsuka), today announced that Otsuka Pharmaceutical Netherlands B.V. has submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat,
Recro Enters Into Master Commercial Supply and Services Agreement With Otsuka
Recro Pharma, Inc., a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, announced the signing of a master supply and services agreement with Otsuka Pharmaceutical Co., Ltd.
Sunovion, Sumitomo Dainippon Pharma and Otsuka Enter Worldwide Development and Commercialization Collaboration
Sunovion Pharmaceuticals Inc.,its parent company Sumitomo Dainippon Pharma Co., Ltd. and Otsuka Pharmaceutical Co., Ltd. announced that the companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds: ulotaront, non-racemic ratio of amisulpride enantiomers, SEP-378614 and SEP-380135.
The companies said the collaboration recognizes a “great need for novel treatments in the area of neuropsychiatric medicine development.”
The Canadian biotech announced the acquisition of two new pipeline assets that align with its focus on autoimmune and kidney-related disease.
Aurinia Announces Licensing Partner Otsuka Filed Initial Marketing Authorization Application (MAA) for Voclosporin with the European Medicines Agency (EMA)
Aurinia Pharmaceuticals Inc. announced that the Company’s licensing partner, Otsuka Pharmaceutical Europe Ltd., filed an initial Marketing Authorization Application for voclosporin for the treatment of lupus nephritis to the European Medicines Agency. LN is a complication of the autoimmune disease systemic lupus erythematosus that seriously impacts the kidneys.
Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
Akebia Therapeutics, Inc. and its collaborator, Otsuka Pharmaceutical Co., Ltd., announced that the U.S. Food and Drug Administration accepted for filing the New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease in both adult patients on dialysis and adult patients not on dialysis.
Otsuka and Lundbeck Announce Decision to Continue Phase III Clinical Trial Evaluating Brexpiprazole for Treatment of Agitation in Patients With Alzheimer's-type Dementia
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce the decision to continue the recruitment of patients in the phase III clinical trial of brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type.
Otsuka and Akebia Announce Submission of New Drug Application to the FDA for Approval of Akebia’s Vadadustat
Indications for renal anemia associated with chronic kidney disease in both dialysis-dependent and non-dialysis-dependent adult patients
Perception Neuroscience And Otsuka Pharmaceutical Announce Collaboration On Development Of PCN-101 (R-ketamine) In Japan For Treatment-of Depressive Disorders
Perception Neuroscience, an atai Life Sciences company focused on developing innovative therapies in neuropsychiatric disorders, and Otsuka Pharmaceutical Co., Ltd., announce a collaboration and licensing agreement for the development and commercialization of Perception's lead molecule, PCN-101 in Japan as a potential treatment for mood disorders such as major depressive disorder and treatment-resistant depression.
Aurinia Announces Collaboration and Licensing Agreement with Otsuka Pharmaceutical Co., Ltd. for the Development and Commercialization of Voclosporin in Europe and Japan
Aurinia to receive $50 million U.S. upfront payment in addition to up to $50 million U.S. in regulatory and reimbursement milestone payments