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Goodwin

Regulatory Updates on Samsung’s Denosumab Biosimilars

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On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

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To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Jones Day

Vital Signs Digital Health Law Update | Winter 2021

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Note from the Editors - Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, November 2018

TSCA/FIFRA/TRI - EPA Issues Final TSCA Fees Rule: On October 17, 2018, EPA issued a final fees rule under TSCA. 83 Fed. Reg. 52694. The final rule largely tracks the proposed rule....more

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