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Latest From Otsuka Holdings Co., Ltd.

Digital Therapeutics Have Arrived But Will Insurers Get On Board?

Will FDA-cleared prescription digital therapeutics be able to follow wellness, chronic disease and sleep disorder apps onto the formularies of major payers? For digital therapeutics companies investing in randomized controlled clinical trials, GMP manufacturing and FDA submissions for products, the current absence of public health insurance coverage is frustrating.

Digital Health Government Payers

Stacked User Fee Calendar Puts Another Record-Setting Year For US FDA Novel Approvals Within Reach

With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.

Drug Review Review Pathway

Otsuka’s ADHD Contender Hits Mark In Phase III

Otsuka's novel ADHD therapy moves closer to a potential filing after meeting its endpoint in two Phase III trials, validating a past acquisition and further bolstering the Japanese firm's CNS prospects. 

Neurology Clinical Trials

Pharmavite Modifying Claims Challenged In Industry Self-Regulation Rapid Review

In response to Church & Dwight’s Single Well-defined Issue Fast Track challenge at NAD, Pharmavite modifies “clinically proven absorption” claims for Nature Made Multi Complete, Prenatal Multi + DHA Softgels, and Prenatal Gummies by disclosing nutrients clinically tested.

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Company Information

  • Industry
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Alamo Pharmaceuticals, LLC
    • Astex Pharmaceuticals, Inc.
    • Avanir Pharmaceuticals, Inc.
    • Daiya Foods Inc.
    • Diatranz Otsuka Limited
    • JIMRO Co., Ltd.
    • Korea Otsuka Pharmaceutical Co., Ltd.
    • Mitsui & Co., Ltd
    • Montigen Pharmaceuticals
    • Neurovance, Inc.
    • Otsuka Australia Pharmaceutical Pty Ltd
    • Otsuka Pharmaceutical Factory, Inc.
    • Otsuka Medical Devices Co., Ltd.
    • Otsuka Pharmaceutical Co., Ltd
    • Otsuka Pharmaceutical India Private Limited
    • ReCor Medical, Inc.
    • Singapore Otsuka Pharmaceutical Co., Ltd.
    • SuperGen, Inc.
    • Taiwan Otsuka Pharmaceutical Co., Ltd.
    • Taiho Pharmaceutical Co., Ltd.
    • Taiho Pharma Canada, Inc.
    • Visterra Inc.
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