Otsuka America Pharmaceutical, Inc.
United States
50 articles about Otsuka America Pharmaceutical, Inc.
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Thursday, the FDA greenlit Ostuka and Lundbeck’s Rexulti as the first treatment in the U.S. for agitation associated with dementia due to Alzheimer’s disease.
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The FDA's agenda includes an advisory committee meeting for Sarepta's delandistrogene moxeparvovec, which, if approved, would become the first gene therapy for Duchenne muscular dystrophy.
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Otsuka and Lundbeck won approval Friday for Abilify Asimtufii, a long-acting injectable that provides two months of symptom relief in patients with schizophrenia or bipolar I disorder.
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FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults
4/28/2023
Otsuka America Pharmaceutical, Inc. and Lundbeck announce the U.S. Food and Drug Administration has approved the New Drug Application for ABILIFY ASIMTUFII® extended-release injectable suspension for intramuscular use, a once-every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar I disorder in adults.
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The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
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Otsuka Pharmaceutical & Lundbeck Present Positive Data From Multiple Phase 3 Studies Showing Brexpiprazole Significantly Improved Symptoms of Agitation in Patients With Alzheimer’s Dementia
12/1/2022
Otsuka America Pharmaceutical, Inc., (Otsuka) and Lundbeck US (Lundbeck) today presented positive efficacy and safety data from multiple Phase 3 studies of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia at the Clinical Trials for Alzheimer’s Disease (CTAD) Congress in San Francisco, CA.
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The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week.
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Otsuka and Lundbeck Announce U.S. FDA Acceptance of New Drug Application for Aripiprazole 2-month, Ready-to-Use, Long-acting Injectable to Treat Schizophrenia and Bipolar I Disorder in Adults
9/13/2022
Otsuka America Pharmaceutical, Inc., (Otsuka) and H. Lundbeck A/S (Lundbeck) announce the U.S. Food and Drug Administration (FDA) acceptance of their New Drug Application (NDA) for aripiprazole 2-month, ready-to-use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults.
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Otsuka and Lundbeck Announce FDA Approval of Supplemental New Drug Application for REXULTI® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients Ages 13-17
1/6/2022
Otsuka and Lundbeck Announce FDA Approval of Supplemental New Drug Application for REXULTI ® (brexpiprazole) to Treat Schizophrenia in Pediatric Patients Ages 13-17.
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Otsuka Responds to the Office of Inspector General’s Favorable Opinion Regarding its Hospital Free Trial Program of Long-Acting Injectable for Inpatient Schizophrenia Treatment
11/17/2021
Otsuka America Pharmaceutical, Inc., acknowledges the importance of the favorable opinion of Otsuka’s Hospital Free Trial Program by the Department of Health and Human Services Office of Inspector General, which provides guidance for the design of manufacturer inpatient free trial programs that provide long-acting anti-psychotic injectable products for the treatment of serious mental illness in a hospital setting.
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GlaxoSmithKline denied reports that they were interested in acquiring Canada’s Aurinia Pharmaceuticals, although some reports claim they are preparing to bid.
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Otsuka Hosts Dr. Nina Vasan, Governor Charlie Baker, and Representative Jamie Raskin at Third Annual Advancing Mental Health Policy: BetterTogether Forum
5/12/2021
Amidst COVID-19, Mental Health Leaders, Policymakers Explore Innovations and Policy Solutions to Strengthen Access to Care for People Living with Serious Mental Illness
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Sozosei Foundation Awards $100,000 to American India Foundation (AIF) COVID-19 Response Fund
5/4/2021
The Sozosei Foundation, a charitable foundation funded by Otsuka America Pharmaceutical, Inc., awarded $100,000 to the American India Foundation COVID-19 Response Fund.
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Otsuka America Pharmaceutical, Inc., Earns Designation as a Great Place to Work-Certified™ Company In 2020
9/29/2020
Otsuka America Pharmaceutical, Inc., (Otsuka) today announced that it is Great Place to Work-Certified™. Certification is a significant achievement. Using validated employee feedback gathered with Great Place to Work’s rigorous, data-driven “For All” methodology, Certification confirms at least seven out of 10 employees have a consistently positive experience at Otsuka. Great Place to Work is t
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Otsuka Is Lead, Founding Sponsor of PBS’ WELL BEINGS Youth Mental Health Project, Featuring Ken Burns Documentary Series
5/21/2020
New Multi-year Public Health Campaign and Documentary Focus on Mental Health Issues
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Otsuka America Pharmaceutical, Inc. Provides Eligible, Newly Uninsured Patients in the U.S. With No-Cost Access to Its Medicines
4/10/2020
Otsuka America Pharmaceutical, Inc. announces today the extension of its patient support program to provide “no-cost” access to its branded portfolio of prescription medicines for patients in the U.S. who have lost a job or health insurance coverage due to the COVID-19 (coronavirus) pandemic.
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Otsuka America Pharmaceutical, Inc. Announces Sozosei Foundation Donations of $500,000 to Local Charities to Support Those Impacted by COVID-19 Pandemic
3/30/2020
Five Local Charities Selected in New Jersey and Washington, D.C. Areas by Otsuka America Pharmaceutical, Inc., the Sozosei Foundation has committed $500,000 in donations to five local charities in central New Jersey and Washington, D.C. areas to support those impacted by the Covid-19 Pandemic. The charities selected focus on an array of critical services such as providing meals and h
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For the 2nd Year in a Row, Otsuka Convenes National Forum on Advancing Mental Health Policy
10/17/2019
Top Experts, Lawmakers and Advocates Come Together to Discuss Policy Solutions to Support Growing Number of Americans Living with Mental Illness
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Here’s a look at some of last week’s clinical trial announcements, including some from the American Society of Clinical Oncology Annual Meeting you might have missed.
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Otsuka Announces First Collaboration Agreement to Bring the ABILIFY MYCITE® System to the US Market
8/30/2018
The ABILIFY MYCITE System, the first drug-device combination product to be approved by FDA to track drug ingestion, will be integrated into Magellan Health’s mental health provider network