Otsuka Pharmaceutical Co., Ltd.
2-9 Kanda Tsukasa-cho
Chiyoda-ku
Tokyo
101-8535
Tel: 03-3292-0021
Website: http://www.otsuka.co.jp/
Email: wwwadmin@tky.otsuka.co.jp
218 articles about Otsuka Pharmaceutical Co., Ltd.
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Sibeprenlimab Receives U.S. FDA Breakthrough Therapy Designation for the Treatment of Immunoglobulin A Nephropathy
2/16/2024
Otsuka Pharmaceutical Development & Commercialization, Inc., ; Otsuka Pharmaceutical, Co. Ltd. ; and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of immunoglobulin A nephropathy.
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A longer-acting formulation of Otsuka Pharmaceuticals’ aripiprazole could help soften the blow of Abilify Maintena’s loss of exclusivity coming later this year, according to a new report from GlobalData.
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AVP-786 was unable to significantly reduce total scores in the Cohen-Mansfield Agitation Inventory versus placebo, Otsuka Pharmaceuticals reported Monday. The company is evaluating the next steps for the drug combination.
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Aurinia Pharmaceuticals Announces Collaboration Partner Otsuka Filed New Drug Application (NDA) for LUPKYNIS® (Voclosporin) in Japan
11/13/2023
Aurinia Pharmaceuticals Inc. announced that the Company’s collaboration partner, Otsuka Pharmaceutical Ltd., filed a new drug application for voclosporin for the treatment of lupus nephritis with the Japanese Ministry of Health, Labour, and Welfare for the manufacture and sale in Japan of voclosporin, a second-generation oral calcineurin inhibitor for the treatment of lupus nephritis.
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The Japanese pharma’s attention deficit/hyperactivity disorder candidate has shown significant symptom improvements in children and adolescents in two late-stage studies.
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Otsuka and Astex announce that the European Commission has approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia
9/19/2023
Otsuka Pharmaceutical Europe Ltd. and Astex Pharmaceuticals, Inc. announce that the European Commission has approved INAQOVI® as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia who are ineligible for standard induction chemotherapy.
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After its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list, Astellas dismissed its Inflation Reduction Act lawsuit this week, while Illumina got new leadership.
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To build its ophthalmology portfolio, Japan’s Otsuka Pharmaceuticals has teamed with RNA editing biotech Shape Therapeutics to develop adeno-associated virus gene therapies for ocular diseases.
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Otsuka collaborates with ShapeTX to develop novel AAV gene therapies for ocular diseases
9/7/2023
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and ShapeTX, the programmable medicine company using AI and RNA to end genetic diseases, today announce a multi-target collaboration to develop intravitreally-delivered adeno-associated viruses (AAVs) for ocular diseases, with options to add additional targets and tissue types.
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Ulotaront failed to meet primary endpoints in two studies. The companies said high COVID-19 placebo effect “may have masked molecule’s therapeutic effect” and plan to discuss next steps with the FDA.
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Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease
5/11/2023
Otsuka Pharmaceutical, Co. Ltd. and Lundbeck LLC announce the U.S. Food and Drug Administration has approved the supplemental New Drug Application of REXULTI® for use in the treatment of agitation associated with dementia due to Alzheimer’s disease.
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This week, the FDA will release its verdict on Biogen and Ionis’ ALS candidate tofersen and three other investigational medicines for psychiatric disorders, hormonal insufficiency and gut infection.
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Otsuka and Lundbeck Published Study Results Showing Aripiprazole 2-Month, Ready-to-Use, Long-Acting Injectable is as Well-Tolerated, and Provides Similar Plasma Levels as Aripiprazole 1-Month for Treatment of Schizophrenia and Bipolar I Disorder
4/4/2023
Otsuka Pharmaceutical Co., Ltd and H. Lundbeck A/S published results from research demonstrating that an investigational long-acting injectable, aripiprazole 2-month, ready-to-use 960 mg, offers comparable tolerability, safety and therapeutic plasma levels as aripiprazole 1-month, ready-to-use 400 mg, currently approved in adult patients for the treatment of schizophrenia or the maintenance treatment of bipolar I disorder.
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Otsuka and Lundbeck Announce FDA Acceptance and Priority Review of sNDA for Brexpiprazole for the Treatment of Agitation Associated With Alzheimer’s Dementia
1/7/2023
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.
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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.
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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.
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Otsuka Pharmaceutical terminated a deal with Akebia Therapeutics, which ends the U.S. and ex-U.S. vadadustat Collaboration and License Agreements.
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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.
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CORRECTING and REPLACING Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer’s Dementia Treated with Brexpiprazole
6/27/2022
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.
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Otsuka Pharmaceutical and Lundbeck Announce Positive Results Showing Reduced Agitation in Patients with Alzheimer’s Dementia Treated with Brexpiprazole
6/27/2022
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.