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Latest From Viatris Inc.

Biosimilars: US FDA’s Updated Scientific Thinking Led To Interchangeability For Amgen's Wezlana

Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.

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Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance

Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.

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Philippines FDA Slashes Approval Timelines For Generic Drugs

The Philippines Food and Drug Administration is set to shorten the timeline for generic review and approval from 120 days to just 45 days, as part of efforts to register new generics and bring down prices.

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Finance Watch: Biopharma Public Offerings Fell In Q4, But Activity Is Booming In Q1

Public Company Edition: Fourth quarter 2023 fundraising fell 25.1% from Q4 2022, including a 24.2% drop in follow-on dollars, but recent activity has been robust, including $300m and $350m offerings by 4DMT and Autolus. Also, BMS sold $13bn in notes to fund Karuna and RayzeBio deals.

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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
    • Drug Delivery
      • Transdermal
  • Other Names / Subsidiaries
    • Acton Pharmaceuticals, Inc.
    • Agila, Bioniche Pharma Holdings Limited
    • Alaven Pharmaceutical, LLC
    • Antula Healthcare AB
    • Bertek
    • Dow B. Hickham
    • Dow Hickam Pharmaceuticals, Inc.
    • Famy Life Sciences
    • Generics (UK) Ltd.
    • Jai Pharma
    • Madaus Pharma
    • Meda AB
    • Meda Pharmaceuticals Inc.
    • Mylan Inc.
    • Mylan Laboratories Limited (formerly Matrix Laboratories Limited)
    • Mylan Specialty (formerly Dey Pharma L.P.)
    • Rottapharm Madaus
    • Mylan Technologies, Inc.
    • Oyster Point Pharma, Inc.
    • UDL Laboratories
    • Viatris Inc.
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