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  • Article

    China Approves World's First Denosumab Biosimilar

    Luye Pharma Group announced last week that China's National Medical Products Administration has approved a marketing launch of BOYOBEI® for treatment of postmenopausal women with osteoporosis at high risk of fractures.
    ChinaFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Aflibercept Biosimilar Updates In Europe

    On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz's aflibercept biosimilar AFQLIR.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Celltrion's Anticancer Biosimilar Debuts In Japan

    According to news reports, Celltrion recently launched VEGZELMA (bevacizumab) in Japan. In September 2022, the drug received sales approval from the Japanese Ministry of Health, Labor and Welfare...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Celltrion Files IND With FDA For Adalimumab Biosimilar

    The trial will evaluate the pharmacokinetics, efficacy, and safety of YUFLYMA in 366 patients with plaque psoriasis.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Celltrion Obtains Canadian Approval To Sell Bevacizumab Biosimilar

    This week, Celltrion obtained full label approval from Health Canada to sell Vegzelma (CT-P16), a bevacizumab biosimilar indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    US Enforcement Agencies Are Turning Up The Heat On Crypto-Related Crime (Cointelegraph Magazine)

    On Jan. 7, Anatoly Legkodymov, founder of the cryptocurrency exchange Bitzlato, was arrested in Miami.
    United StatesTechnology
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Bank Settles Class Action Over Finance Charge Hikes

    Parties in a putative class action alleging that defendant improperly raised annual percentage rates charged to its credit card holders have reached a $10 million settlement.
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    CFPB Issues Final Policy On Disclosure Of Consumer Complaint Data

    The CFPB issued a final policy statement providing guidance on how it plans to publicly disclose certain consumer complaint data.
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    CFPB Issues Student Loan Advisory On School-Endorsed Debit Cards

    The CFPB issued a consumer advisory to all students regarding the use of school-endorsed debit cards for the receipt of scholarship and student loan proceeds.
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    CFPB Releases Draft Five-Year Strategic Plan

    The CFPB released its draft five-year strategic plan, which outlines four goals over the next five years, including:
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    DOJ Reaches Settlement In Fair Lending Suit (Consumer Financial Services Alert - July 24, 2012)

    The Department of Justice announced the second largest fair lending settlement—$175 million—in the Department’s history.
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    FHFA Imposes Higher Origination Costs For Mortgages Backed By GSEs In Five States

    The Federal Housing Finance Agency announced proposed guarantee fee pricing adjustments in Connecticut, Florida, Illinois, New Jersey and New York for mortgages owned or guaranteed by Fannie Mae or Freddie Mac.
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Massachusetts Legislature Approves Changes To Foreclosure Procedures

    The Massachusetts House of Representatives unanimously passed House Bill 4087, "An Act to Prevent Unlawful and Unnecessary Foreclosures."
    United StatesConsumer Protection
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    FDIC Responds To CFPB Guidance On Compensation Rules For Mortgage Loan Originators

    The FDIC confirmed that the CFPB’s guidance on the mortgage loan originator compensation rules (reported in the April 3, 2012 edition of the Alert) is applicable to FDIC-regulated banks and has directed its banks to ensure that their policies and procedures are consistent with the CFPB’s compensation rules.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Treasury And FRB Extend Effective Date For Implementation Of Compliance Requirements Of Rule Restricting Internet Gambling

    The Department of the Treasury and the FRB extended to June 1, 2010 the effective date for financial services providers to implement the compliance requirements of a final rule that imposes restrictions on online gambling pursuant to the Unlawful Internet Gambling Enforcement Act of 2006.
    United StatesCorporate/Commercial Law
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    DOL Provides Flexibility On Timing Of Disclosures For Participant-Directed Plans

    The Department of Labor recently issued Field Assistance Bulletin 2013-02A under the Employee Retirement Income Security Act of 1974.
    United StatesFinance and Banking
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    FTC Focused On FCRA Enforcement (Consumer Financial Services Alert)

    Robert Schoshinski, Assistant Director of the Division of Privacy and Identity Protection of the FTC, testified before the House Subcommittee on Financial Institutions and Consumer Credit.
    United StatesFinance and Banking
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    GAO Releases Report On Regulatory Oversight Of SCRA’s Foreclosure (Consumer Financial Services Alert - July 24, 2012)

    The GAO released a report on the regulatory oversight of the Servicemember Civil Relief Act, which provides protections to active duty servicemembers, in the foreclosure context.
    United StatesFinance and Banking
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Senate Amendment Proposes Changes to "Carried Interest" Legislation

    Following its Memorial Day recess, the U.S. Senate has taken up consideration of H.R. 4213, the bill containing the proposed changes to the taxation of carried interest as a revenue offset, passed by the House of Representatives on May 28.
    United StatesTax
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    FTA Evaluation Criteria Allows For More Transit Expansions To Receive Federal Funding

    The Federal Transit Administration late last month released new evaluation criteria for transit projects vying for funds from the New Starts and Small Starts programs.
    United StatesTransport
    Goodwin Procter LLP
    Goodwin Procter LLP

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