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United States: Series 2: How To Determine Your Risk Category And What It Means To Be 'High-Risk' - Goodwin Procter LLPThe new EU Artificial Intelligence Act ("AI Act") is a risk-based framework, ranging from outright prohibitions on certain types of systems to light regulation of others.Mondaq - Published | |
United States: CFPB Bemoans "Junk Fees" In Mortgage Servicing - Goodwin Procter LLPOn April 24, 2024, the CFPB released its Supervisory Highlights, Mortgage Servicing Edition, (Issue 33, Spring 2024) which provides insight on the CFPB's current focus in examining mortgage loan..Mondaq - Published | |
United States: FDA Updates Draft Guidance On Promotional Communications Of Prescription Biologics And Biosimilars - Goodwin Procter LLPOn April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled "Promotional Labeling and Advertising Considerations...Mondaq - Published | |
United States: FinCEN Proposed The Renewal Of Its Existing Information Collection Requirements Previously Promulgated Under The BSA - Goodwin Procter LLPOn April 22, FinCEN proposed to renew its existing information collection requirements previously promulgated under the BSA, estimated the regulatory burden that this renewal...Mondaq - Published | |
United States: Debt Download - Goodwin Procter LLPVolume of new issues in the broadly syndicated loan (BSL) market continued to climb in March, hitting $118.4 billion for the month, from $61.7 billion in February, according to Covenant Review.Mondaq - Published | |
United States: Navigating Bank Failures: Lessons Learned - Goodwin Procter LLPWhen Silicon Valley Bank (SVB) failed on March 10, 2023, it caused significant alarm throughout the US economy – from depositors, customers, and counterparties of SVB to those of all banks...Mondaq - Published | |
United States: Accord BioPharma, Inc. Announces FDA Approval Of HERCESSI (Trastuzumab-strf) - Goodwin Procter LLPOn April 29, 2024, Accord BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) approved HERCESSI (trastuzumab-strf).Mondaq - Published | |
United States: Does The EU AI Act Classify Your AI System As High Risk? - Goodwin Procter LLPNow that the European Parliament has approved the EU AI Act, you should understand how the broad AI regulation affects your business. First, identify your role in the AI value chain...Mondaq - Published | |
United States: DOL Issues New Rule Raising Minimum Salary Thresholds For Overtime Exemptions - Goodwin Procter LLPOn April 22, 2024, the Department of Labor (DOL) released the final version of a new rule to raise the minimum salary threshold for most employees covered by the so-called white-collar exemptions...Mondaq - Published | |
United States: Alvotech Announces Positive Topline Results From Confirmatory Clinical Study For Its Proposed Golimumab Biosimilar - Goodwin Procter LLPOn April 23, 2024, Alvotech announced "positive topline results from a confirmatory clinical study for AVT05," Alvotech's proposed golimumab biosimilar to Janssen Biotech, Inc.'s...Mondaq - Published | |
United States: CFPB Updates Its Procedures For Determining Which Nonbanks It Can Supervise - Goodwin Procter LLPThe Consumer Financial Protection Bureau (CFPB) recently issued a new procedural rule to streamline how it determines which nondepository institutions it has the authority to supervise.Mondaq - Published | |
UK: Sustainability Disclosure Rules In The UK: Extending The FCA's Regime To Portfolio Managers - Goodwin Procter LLPIn our previous alert The FCA's Sustainability Disclosure Requirements and Labelling Regime (SDR): A Flexible Regime for UK Private Fund Managers, we examined the final framework...Mondaq - Published | |
United States: FTC Issues Final Rule Prohibiting Most Post-Employment Non-Compete Agreements - Goodwin Procter LLPOn April 23, 2024, the United States Federal Trade Commission ("FTC") issued a Final Rule (the "Final Rule") that would prohibit the use of non-compete clauses with most American workers.Mondaq - Published | UK: Healthcare M&A And Financing Trends And Predictions For 2024 - Goodwin Procter LLPThe healthcare sector was one of the biggest beneficiaries of the pandemic influenced boom in asset values, but has faced significant headwinds since the middle of 2022.Mondaq - Published |
United States: The SEC Amends The Internet Adviser Exemption - Goodwin Procter LLPOn March 27, 2024, the US Securities and Exchange Commission (SEC) adopted amendments to Rule 203A-2(e) of the Investment Advisers Act of 1940...Mondaq - Published | United States: CFPB Issues Circular About Deceptive Marketing Practices In Connection With Remittance Transfers - Goodwin Procter LLPThe majority of the remittance transfers sent are electronic transfers of funds sent by consumers in the United States to recipients in other countries.Mondaq - Published |
United States: CFPB Enters Into Consent Order With For-Profit Coding School - Goodwin Procter LLPOn April 17, 2024, the Consumer Finance Protection Bureau (CFPB) announced that it had entered into a consent order with BloomTech Inc., d/b/a Bloom Institute of Technology (BloomTech)...Mondaq - Published | United States: National Bank Settles With NY Attorney General For $700K - Goodwin Procter LLPOn April 17, 2024, the New York State Attorney General (NY AG) announced that it entered into an Assurance of Discontinuance (AOD) with a national bank...Mondaq - Published |
United States: Supreme Court Rejects Securities Lawsuit Based On "Pure Omission" From SEC Filings - Goodwin Procter LLPIn a narrow but potentially significant decision, the Supreme Court has held that securities-fraud plaintiffs cannot recover based on a "pure omission" from a company's public statements ...Mondaq - Published | United States: Delaware Supreme Court Holds That Boards Must Satisfy The MFW Framework In Controller Transactions To Obtain Business Judgment Deference - Goodwin Procter LLPIn 2014, the Delaware Supreme Court held in Kahn v. M&F Worldwide Corp. that a court will apply the entire fairness standard of review to freeze-out merger transactions between a controlled corporation..Mondaq - Published |
United States: Featured Speaker: State Of The Real Estate Capital Markets, REIT, Private And IPO Market (Video) - Goodwin Procter LLPRoy March, Chief Executive Officer, Eastdil SecuredMondaq - Published | Anil Kapoor and Sonam Kapoor Unveiled the Seventh Edition of Ariel #ShareTheLoad Film· 72%* of women feel that if they are not at home for some time, their households will face problems. · 72%* of women feel that household responsibilities stay on top of their minds when they are..NewsVoir - Published |
United States: A Look Ahead In Life Sciences: What We Are Tracking In Q2 2024 And Beyond - Goodwin Procter LLPAs the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape.Mondaq - Published | United States: Agencies Extend Applicability Date Of Certain Provisions Of Their CRA Final Rule - Goodwin Procter LLPOn March 21, the Agencies jointly issued an interim final rule granting more time before certain provisions of the previously issued final rule regarding the CRA come into effect.Mondaq - Published |
United States: FinCEN Publishes An Administrative Ruling Regarding Customer Identification Program And Customer Due Diligence Requirements For Designated Beneficiaries Of Individual Retirement Accounts - Goodwin Procter LLPOn March 15, FinCEN issued an administrative ruling affirming that broker-dealers must comply with CIP and CDD requirements when distributing to a beneficiary of IRA funds inherited as part of a..Mondaq - Published | United States: Wisconsin Becomes Third State To Enact Law Regulating Earned Wage Access Services - Goodwin Procter LLPFollowing Nevada and Missouri in 2023, Wisconsin has become the third state (and the first in 2024) to enact a law that establishes a financial services oversight regime for earned wage access..Mondaq - Published |
UK: The New UK Public Offers Regime: Three Key Takeaways And Next Steps - Goodwin Procter LLPThe long-awaited Public Offers and Admissions to Trading Regulations 2024,the legislation replacing the UK Prospectus Regulation, came into effect on 29 January 2024 ...Mondaq - Published | United States: ELTIF 2.0 RTS: Commission Orders ESMA To Think Again - Goodwin Procter LLPIn our previous alert, we looked at the draft revised Regulatory Technical Standards (RTS) supplementing the amended ELTIF Regulation (ELTIF 2.0) published by the European Securities and Markets..Mondaq - Published |
United States: Women's History Month Spotlight: Emmanuelle Charpentier And Jennifer Doudna - Goodwin Procter LLPIn honor of Women's History Month, Big Molecule Watch recognizes Emmanuelle Charpentier and Jennifer Doudna, who won the Nobel Prize for a method for genome editing, commonly called CRISPR....Mondaq - Published | United States: What's Hot In Commercial Real Estate, In Charts - Goodwin Procter LLPBrighter days could be coming for the commercial real estate industry after a cooldown in recent years.Mondaq - Published |
United States: Celltrion Announces Commercial Availability Of ZYMFENTRA™ (Infliximab-dyyb) - Goodwin Procter LLPCelltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.Mondaq - Published | United States: Updates On Aflibercept BPCIA Litigation - Goodwin Procter LLPAs we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. ("Regeneron") filed a motion seeking to establish a multi-district litigation ("MDL")...Mondaq - Published |
United States: FDA Approves Sandoz Denosumab Biosimilars - Goodwin Procter LLPOn March 5, Sandoz announced that the FDA approved its denosumab biosimilars, WYOST and JUBBONTI, as interchangeable with Amgen's XGEVA and PROLIA.Mondaq - Published | Worldwide: Developments In W&I Insurance In Asia - Goodwin Procter LLPIn recent years, the number of insurers offering M&A insurance (known as warranty and indemnity (W&I) insurance) in Asia has doubled.Mondaq - Published |
UK: Q&A With TusPark's Wei Meng On Life Sciences And Operational Real Estate - Goodwin Procter LLPGoodwin Partner Raymond Fang talks with TusPark's head of UK innovation and real estate, Wei Meng, about building life sciences ecosystems and the operational nature of real estate in the sector.Mondaq - Published | United States: In Re Sears Hometown And Outlet Stores, Inc. Stockholder Litigation, 2024 WL 262322 (Del. Ch. Jan. 24, 2024) - Goodwin Procter LLPUntil recently, Delaware law offered no clear standard of review for a controller's exercise of stockholder voting power.Mondaq - Published |
United States: Remaining Steadfast: Goodwin's Life Sciences In 2023 - Goodwin Procter LLPThis annual recap highlights Goodwin's continued determination and agility as a full-service, integrated global practice. Committed to being a global destination life cycle law firm...Mondaq - Published | United States: FTC And DOJ Launch New Cross-Government Inquiry On The Role Of Private Equity In Healthcare - Goodwin Procter LLPOn March 5, 2024, the Federal Trade Commission (FTC), Department of Justice (DOJ), and Department of Health and Human Services (HHS, and collectively with the FTC and DOJ, the Agencies)...Mondaq - Published |
United States: Biocon Settles With Janssen, Securing U.S. Market Entry Date For Ustekinumab Biosimilar - Goodwin Procter LLPOn February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson ("J&J") regarding Bmab 1200, Biocon's proposed..Mondaq - Published | United States: How Beauty Companies Can Mitigate Risks Associated With AI Technology Use - Duane Morris LLPFrom L'Oreal and Olay to Procter & Gamble and Shiseido, companies across the beauty industry are embracing AI technology with open arms.Mondaq - Published |
United States: FINRA Proposes To Add 'Knowledgeable Employees' To Category Of Persons Who May Receive Projections And Targeted Returns Under Rule 2210 - Goodwin Procter LLPThis amendment builds on FINRA's recent willingness to relax the prohibition on the use of projections and targeted returns in the marketing materials broker-dealers deliver to institutional...Mondaq - Published | United States: Genentech And Partners Voluntarily Dismiss IPR Appeals Related To Genentech's ACTEMRA® (Tocilizumab) - Goodwin Procter LLPOn February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB's Final Written Decisions in IPR2022-00578 and IPR2022-00579.Mondaq - Published |