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Statutory Requirements Life Sciences

McDonnell Boehnen Hulbert & Berghoff LLP

Another Group of Law Professors File Amicus Brief in Amgen v. Sanofi

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more

McDonnell Boehnen Hulbert & Berghoff LLP

U.S. Government Files Amicus Brief in Amgen v. Sanofi

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

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