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  • Article

    EMA Recommends Denying Marketing Authorization For Prestige BioPharma's TUZNUE And HERVELOUS (trastuzumab)

    In March, we reported that Prestige BioPharma had announced positive safety and efficacy results in a Phase III study for HD201.
    GlobalFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    FDA Accepts BLA For Shanghai Henlius Biotech's HLX11, A Pertuzumab Biosimilar

    On February 2, 2025, Shanghai Henlius Biotech, Inc. ("Henlius") announced FDA acceptance of the Biologics License Application (BLA) for HLX11...
    GlobalFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    International Biosimilar Market Updates

    Stelis Biopharma Receives Positive Recommendation for FORSTEO Biosimilar in Europe.
    GlobalFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Sun Pharma To Acquire Organon

    On April 26, 2026, Sun Pharmaceutical Industries Limited (“Sun Pharma”) and Organon & Co. (“Organon”) announced an agreement for Sun Pharma to acquire all outstanding shares of Organon...
    IndiaFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    UK Employee Share Plans: 6th Of July HMRC Reporting Deadline

    Businesses that award shares, options or other securities to UK employees, directors or officer holders need to be aware of the July 6 deadline to submit an Employment Related Securities (ERS)...
    United KingdomEmployment and HR
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Alvotech Requests That FDA Refuse To License CHO-Cell Derived Ustekinumab Biosimilars As Interchangeable Until The Effects Of Sialylation Are Evaluated

    Alvotech recently submitted a Citizen Petition to the FDA requesting that the agency refuse to license any ustekinumab biosimilar as interchangeable with STELARA if it is manufactured using a Chinese hamster ovary ("CHO")...
    United KingdomFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    The UK's MHRA Updates Its Guidance On Licensing Of Biosimilars

    On November 7, 2022, the UK's Medicines and Healthcare Products Regulatory Agency ("MHRA") updated its "Guidance on the licensing of biosimilar products"...
    United KingdomFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    REMICADE Antitrust Settlement Receives Final Approval

    In 2017, three indirect-purchaser antitrust class actions were filed against Johnson & Johnson and Janssen Biotech, Inc., alleging that they engaged in anticompetitive conduct...
    United StatesAntitrust/Competition Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    FINRA Reminds CCOs About Potential Supervisory Liability

    FINRA recently published Regulatory Notice 22-10 reminding firms of the scope of Rule 3110 (Supervision) and the potential liability of ...
    United StatesCompliance
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    CFBP And NY AG Sue Global Payment Company

    The suit alleges that the defendant failed to correct significant deficiencies in its remittance transfer systems that were identified during a CFPB examination in 2014 and re-examination in 2019.
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    CFPB Terminates Consent Order Against Credit Union

    On July 21, 2025, the Consumer Financial Protection Bureau (CFPB) announced that it had terminated its October 2024 consent order with a Florida-based credit union.
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Colorado Attorney General Reaches Settlement With Affiliated Lender And Debt Management Company

    In Colorado, it is unlawful for a company that provides debt management services to also lend money or provide credit to the same consumer.
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    FAQs On New Executive Incentive Compensation Clawback Rules

    On October 26, 2022, the U.S. Securities and Exchange Commission (the "SEC") adopted regulations implementing Section 10D of the Securities Exchange Act of 1934...
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    FTC Enters Settlement With California-based Lead Generator

    On January 2, 2024, the Federal Trade Commission (FTC) announced it had reached a settlement with a California-based lead generator resolving allegations...
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Additional Proxy Materials

    While annual meeting season for calendar year-end companies is heading towards the home stretch, numerous companies are still filing additional proxy materials.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Chairman Atkins Looking To Curb Proxy Advisor Influence

    In a Friday appearance on Fox Business, SEC Chairman Paul Atkins signaled that the Securities and Exchange Commission is increasingly focused on curbing the influence of proxy advisory firms.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Holiday Hours: The SEC's EDGAR System Closed Tuesday And Wednesday

    The SEC announced that the EDGAR system will be closed on both Tuesday, December 24, 2024 and Wednesday, December 25, 2024. December 25 is a federal holiday and December 24 will be treated...
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Proxy Statement Voting Disclosures

    Every year public companies need to disclose the voting standards applicable to proposals included in their annual meeting proxy statements.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Public Company Stockholder Meeting Adjournment Proposals

    Our Public Company Advisory Practice has been seeing an increase in situations where clients are having difficulty reaching a quorum for an annual or special meeting or in securing enough votes to pass a proposal.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Revised C&DI Permits Filing And Declaring Effective Non-Automatically Effective Forms S-3 Prior To Filing Part III Information

    On March 20, 2025, the staff of the SEC's Division of Corporation Finance issued revised Securities Act Forms C&DI Question 114.05 indicating that non-automatically effective registration statements on Form S-3 may now be filed and declared effective after an issuer has filed its Form 10-K but prior to filing its Part III information that will be incorporated by reference into the Form 10-K.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP

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