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  • Article

    Sandoz's High Concentration Adalimumab Biosimilar Application Accepted By EMA

    Sandoz recently announced that the EMA (European Medicines Agency) has accepted its application for a 100 mg/ml citrate-free formulation of its biosimilar HYRIMOZ® (adalimumab).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Sandoz Announces Approval For Biosimilar Hyrimoz® (adalimumab-adaz)

    On March 21, 2023, Sandoz, announced FDA approval of its citrate-free high-concentration formulation (HCF) of its biosimilar HYRIMOZ® (adalimumab-adaz) injection.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Sandoz Announces New Global "Act4Biosimilars" Initiative

    On May 31, 2022, Sandoz announced the launch of a new global initiative called "Act4Biosimilars" to help address health inequity and inequality worldwide.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Teva And Prestige Biopharma Enter Licensing Agreement To Commercialize Their Trastuzumab Biosimilar

    On October 20, 2025, Teva Pharmaceuticals International GmbH ("Teva") announced a licensing agreement with Prestige BioPharma Ltd. ("Prestige BioPharma") to commercialize TUZNUE® (trastuzumab), a biosimilar to Genentech's HERCEPTIN (trastuzumab), in a majority of European countries.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Vertex Presents New CASGEVY® Data In Patients 5-11 Years And Announces Plan For Global Regulatory Submissions

    On December 6, 2025, Vertex Pharmaceuticals Inc. ("Vertex") announced data from several studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel)...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    PTAB Issues Final Written Decisions Finding Claims Of Tocilizumab-related Patents Invalid

    On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc.
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Purple Book Updates

    In 2021, the FDA's Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance.
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    ‘Our Rules Have To Evolve': The Crypto Industry Is Trapped In Regulatory Purgatory (Fortune)

    Many in the crypto industry have been calling for clear guidance from government regulators, especially as new sectors like DeFi evolve and high-profile companies collapse.
    United StatesTechnology
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Celltrion Wins Brazilian Federal Tender For Trastuzumab For Fifth Consecutive Year

    On September 13, 2024, Celltrion announced that its Brazilian subsidiary won the Federal Government of Brazil's bid to supply HERZUMA (trastuzumab-pkrb) for the fifth consecutive year...
    WorldwideFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Video

    Potential For REIT IPOs Limited, Menna Says (Video Content)

    Gil Menna, partner with the law firm of Goodwin Procter, joined REIT.com for a video interview in Chicago at REITWeek 2013: NAREIT's Investor Forum.
    United StatesFinance and Banking
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    SEC Puts Shareholder Proxy Access Rules on Hold Pending Resolution of Legal Challenge

    Yesterday, the Securities and Exchange Commission ("SEC") issued a formal stay of the effectiveness of the newly adopted shareholder proxy access rules in the face of a legal challenge brought by the Business Roundtable and the U.S. Chamber of Commerce.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Goodwin Advises Tinicum and Blackstone on Their Recommended £1.275 Billion Offer for Senior Plc

    A consortium of investment funds advised by Tinicum and Blackstone has launched a £1.275 billion recommended offer for FTSE 250-listed Senior plc, an international engineering solutions provider serving aerospace, defence, and energy markets. This high-profile public-to-private transaction highlights continued private equity interest in UK listed companies with strong fundamentals and long-term growth potential in the defence and aerospace sector.
    United KingdomFinance and Banking
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Edwin O’Connor Participates In SEC’s Small Business Capital Formation Advisory Committee Meeting

    Goodwin's Public Company Advisory practice provides comprehensive updates on SEC regulatory developments, capital markets reform, and corporate governance matters affecting public companies. This collection covers Chairman Atkins' initiatives to revitalize IPO markets, disclosure simplification efforts, Section 16 reporting requirements for foreign private issuers, crypto asset classification guidance, and practical compliance updates including Nasdaq's proposed immediate delisting rule for companies below
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    SEC Submits Several Rulemakings For Review

    The SEC has submitted three major rulemaking projects to OIRA for review that will significantly impact public companies and capital raising activities. These proposals address shareholder proposal regulations, proxy solicitation processes, and retail investor access to private markets. Once OIRA completes its review, the Commission will vote on these rulemakings before publishing the proposals.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    COBRA Subsidy Extended

    The temporary federal COBRA subsidy initially provided by the American Recovery and Reinvestment Act of 2009 was first extended to apply to involuntary terminations of employment through February 28, 2010.
    United StatesEmployment and HR
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    The Inflation Reduction Act & Medicare Pricing For Drugs And Biologics

    The new Medicare price negotiation program, inflation-based rebates, and other changes to how Medicare ..
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Video

    Propsci Perspectives: Breakthrough Properties (Video)

    The Goodwin Propsci team has partnered with several well-known companies for a short video series that explores what's happening in the real estate life sciences industry.
    United StatesReal Estate and Construction
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Propsci Perspectives: JLL

    The Goodwin Propsci team has partnered with several well-known companies for a short video series that explores what's happening in the real estate life sciences industry.
    United StatesReal Estate and Construction
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Silicon Valley Bank Update (Video)

    On the morning of March 10, 2023, the Federal Deposit Insurance Corporation took control of the assets of Silicon Valley Bank. That afternoon, partners from Goodwin's Banking, Bankruptcy
    United StatesWealth Management
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Goodwin Releases Update To Its Comprehensive Guide To Biosimilars Litigation And Regulation In The U.S.

    Global law firm Goodwin today announced the release of the 2023-2024 annual update to its definitive biosimilars treatise Guide to Biosimilars Litigation and Regulation in the U.S.
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP

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