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Nippon Shinyaku Co. Ltd.

www.nippon-shinyaku.co.jp

Latest From Nippon Shinyaku Co. Ltd.

Oncology Dominant As Japan Maintains Approvals Pace

Despite the emergence of the coronavirus pandemic at the end of the period, Japan’s regulatory authorities maintained an annual pace of new drug approvals on a par with the previous year, with expedited programs helping several drugs to market.

Japan Approvals

JT Gains World-First Topical JAK Inhibitor Approval

Latest new drug approvals in Japan include the first anywhere for a topical JAK inhibitor and also a marketing clearance for a new contender in the large prostate cancer space.

Japan Approvals

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Drug Review Drug Approval Standards

Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Approvals Drug Review
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Cancer
  • Cardiovascular
  • Gynecological, Urological
  • Immune Disorders
  • Infectious & Viral Diseases
  • Musculoskeletal & Connective Tissue Disorders
  • Neurology, Nervous System
  • Respiratory, Pulmonary
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Asia
      • Pacific Rim
        • Japan
  • Parent & Subsidiaries
  • Nippon Shinyaku Co. Ltd.
  • Senior Management
  • Shigenobu Maekawa, Pres.
    Taro Sakurai, Gen. Mgr., Fin. & Accounting
    Akira Matsuura, Gen. Mgr., R&D
  • Contact Info
  • Nippon Shinyaku Co. Ltd.
    Phone: (81) 75 321 1111
    14 Nishinosho Monguchi-cho, Kisshoin
    Minami-ku
    Kyoto, 601-8550
    Japan
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