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BioWorld - Monday, December 15, 2025

Regulatory

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Home » Topics » Regulatory
  • Digital privacy globe
    Dec. 15, 2025
    By Mari Serebrov

    US Biosecure Act a vote away from law

    “If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
  • Dec. 15, 2025
    By Mari Serebrov

    US senators want the lowdown on Trump biopharma pricing deals

    A group of eight Democratic senators is asking biopharma companies to spill the beans about their private most-favored-nation pricing deals with U.S. President Donald Trump. Led by Sen. Ron Wyden, D-Ore., ranking member of the Senate Finance Committee, the senators sent letters Dec. 11 to Astrazeneca plc, Eli Lilly and Co., Novo Nordisk A/S and Pfizer Inc. seeking the details of those deals. While it’s difficult to discern how the deals will benefit patients, it’s clear the companies stand to gain a lot from the agreements, the letter asserted.
  • Europe pills syringe flag
    Dec. 15, 2025
    By Nuala Moran

    EU agrees to pharma legislation, but the industry isn’t happy

    The EU finally reached agreement on an update of the 20-year-old pharmaceutical legislation, more than five years after the EU Commission first put forward the case for reform and following two and a half years of negotiations on the new rules.
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Blog Posts

  • Aug. 11, 2016
    By Mari Serebrov

    Will biosimilar carve-outs put R&D for older MAbs on ice?

  • Feb. 27, 2013
    By Mari Serebrov

    Omontys Recall Rings Alarm Over Biosimilars

  • Jan. 29, 2013
    By Mari Serebrov

    Don’t Call Them Generics!

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  • Jihyun Kim
  • Tamra Sami
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  • Brian Orelli
  • Katie Pfaff
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