Goodwin (JD Supra United States)

3280 results for Goodwin (JD Supra United States)

  • Navigating the New Normal: Adaptive Reuse of Space

    When you think of adaptive reuse, you likely associate it with turning a rustic barn, an old-time firehouse or former chapel into a cottage, modern loft or chic house. More broadly, however, adaptive reuse is any redesign, renovation or reuse of existing built space originally dedicated to one use but then repurposed for another. In the context of propsci, which we define as space that caters to...

  • Federal Reserve Hints at Government-Backed Cryptocurrency

    Federal Reserve Hints at Government-Backed Cryptocurrency; Third Circuit Affirms Dismissal of Securities Fraud Class Action Against Shutterfly Inc. Regarding Allegedly Misleading Financial Projections; Ninth Circuit Holds Federal Loss Causation Standard Not Met in Investor’s State Law Securities Action Against Uber; Taking Judicial Notice of SEC Cease and Desist Order, District of Maryland Denies

  • EEOC Releases Updated COVID-19 Vaccine Guidelines for Employers

    In This Issue. The Equal Employment Opportunity Commission (EEOC) released updated COVID-19 vaccine guidelines for employers. Meanwhile, the Board of Governors of the Federal Reserve System (Federal Reserve) remained busy this week, having: (1) finalized a rule amending Regulation D with regard to interest on reserve balances; (2) hinted at the establishment of a government-backed cryptocurrency;

  • Get Your Board On Board with Limiting SPAC-Related Litigation Risk

    Although Special Purpose Acquisition Companies (SPACs) have been around for decades, only recently have they experienced an incredible surge in popularity and, inevitably, attention from regulators and plaintiffs’ law firms. As a result of this increase in scrutiny, it is crucial that SPAC sponsors, their boards of directors, and the directors and officers of acquisition targets take steps to...

  • Biogen and Bio-Thera Announce Positive Phase 3 Results On Tocilizumab Biosimilar

    Biogen Inc. and Bio-Thera Solutions, Ltd. today announced positive Phase 3 results on BAT1806, a proposed biosimilar to ACTEMRA®/RoACTEMRA (tocilizumab). According to the Biogen press release, the study met its primary endpoints, demonstrating equivalent efficacy and comparable safety to the reference product in patients with moderate to severe rheumatoid arthritis inadequately controlled with...

  • EEOC Releases Updated COVID-19 Vaccine Guidance for Employers

    On May 28, 2021, the Equal Employment Opportunity Commission (“EEOC”) updated and expanded on its guidance about how federal equal employment opportunity laws (“EEO laws”) may apply to potential employer requirements that employees be vaccinated against COVID-19 (the “Guidance”). The original EEOC guidance on the same subject was summarized in a previous Goodwin Client Alert.

  • Seventh Circuit Yet Again Reaffirms Spokeo Principle That Bare FDCPA Violation Is Not Actionable

    On May 14, 2021, the Seventh Circuit United States Court of Appeals issued a decision reaffirming the rule from “a slew of cases” that, without injury, a Fair Debt Collection Practices Act (FDCPA) claim alleging a bare procedural violation is not actionable.  The case - Markakos v. Medicredi, Inc., No. 20-2351 - involved an allegation that the plaintiff received two letters from a debt collector...

  • Study Concludes Two Adalimumab Biosimilars may be as Safe and Effective as Originator

    An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two adalimumab biosimilars, ABP501 (Amgen) and SB5 (Samsung Bioepsis). The authors concluded from this study that both biosimilars seem to be as safe and effective as the originator,...

  • Drug Development Scorecard – A Guide for Companies Navigating the FDA Drug and Biologic Development and Approval Process

    Developing a new drug or biologic is a complex process. Based on our extensive experience advising early-stage and clinical-stage companies, the Goodwin FDA team created this “scorecard” for companies to use as a guide as they navigate the FDA drug development and approval process. The drug development scorecard (or checklist) can help companies keep track of progress, identify opportunities, and

  • Biden Executive Order Likely to Push Private Sector Forward on Cybersecurity

    On May 12, President Biden signed an Executive Order on Improving the Nation’s Cybersecurity. The order comes on the heels of a number of recent widely reported cybersecurity crises, including the Solar Winds and Microsoft Exchange compromises, that brought renewed attention to the glaring gaps in supply chain security. By wading into the issue of software security in the federal procurement...

  • Senate Votes to Repeal the OCC’s True Lender Rule

    On May 11, 2021, in a 52-47 vote, the United States Senate passed a Congressional Review Act resolution to revoke the Office of the Comptroller of the Currency’s (OCC) True Lender Rule. The Congressional Review Act, passed in 1996, permits Congress to pass a joint resolution of disapproval that, with the President’s signature, can repeal a recent rule issued by a federal agency and prohibits the...

  • President Biden Signs Executive Order Addressing Climate-Related Financial Risks

    In This Issue. President Biden signed an executive order addressing climate-related financial risks; the Office of the Comptroller of the Currency (OCC) finalized a rule applicable to national banks and federal savings associations regarding the withdrawal period requirement for collective investment funds; and the federal banking agencies finalized changes to Call Reports proposed by the...

  • Reopening Massachusetts: Commonwealth Set To Ease Mask Mandates, Business Restrictions

    On May 17, 2021, Massachusetts Gov. Charles Baker announced that effective May 29, 2021 the Commonwealth will lift all remaining COVID-19 restrictions on businesses. In addition, effective May 29, 2021 the Commonwealth will rescind its current face covering order. Gov. Baker’s announcement expedited the Commonwealth’s anticipated full reopening date by more than two months.

  • International Biosimilar Launches: Ujvira and PrInclunox®

    On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar.  The drug is a trastuzumab emtansine biosimilar - using Genentech’s Kadcyla as the reference product - that will be marketed under the name Ujvira for use in treating early and advanced HER2 positive breast cancer.

  • FDA Answers New Questions on Foreign Trial Sites Operating Under INDs

    On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions from sponsors, clinical investigators, and institutional review boards (IRBs), and it provides new information on waivers of the Form FDA 1572 signature requirement, which is

  • Meiji Announces Promising Phase I Results for Ustekinumab Biosimilar and Initiation of Phase III Clinical Trial

    On May 21, 2021, Meiji Seika Pharma Co, Ltd. announced that phase I clinical trials of DMB-3115, its proposed ustekinumab (STELARA®) biosimilar, demonstrated bioequivalence to reference products marketed in Europe and the United States. Meiji is co-developing ustekinumab under a 2011 strategic collaboration partnership agreement with Dong-A Socio Holdings.

  • CFPB and Debt Settlement Company Agree to Stipulated Final Judgment and Order

    On May 17, 2021, the Consumer Financial Protection Bureau (CFPB) announced that it has entered​ into a stipulated judgment​ and order​ to resolve a civil action that it previously filed against a debt settlement company in the U.S. District Court for the District of Massachusetts on December 1, 2020, as previously reported he​​re. ​The CFPB initially filed suit against the debt settlement...

  • FTC Settles Claims with Student Loan Debt Relief Companies

    On May 17, 2021, the Federal Trade Commission (FTC) announced​ a settlement​ with several student loan debt relief companies and their respective owners. The settlement stems from a complaint filed in 2019, in which the FTC alleged the companies charged illegal upfront fees and led consumers to believe the fees​ were going towards consumers’ student loans in violation of Sections 13(b) and 19 of...

  • OCC Reconsiders Controversial Revisions to CRA Rules

    In This Issue. The Office of the Comptroller of the Currency (OCC) announced that it will reconsider its controversial June 2020 final rule revising its Community Reinvestment Act (CRA) rules, and published its Semiannual Risk Perspective for Spring 2021; the Federal Deposit Insurance Corporation (FDIC) requested information and solicited comments from interested parties about insured depository...

  • Lessons (Still Being) Learned Regarding Hospitality Finance in the Covid-19 Age

    The COVID-19 pandemic wreaked havoc across the real estate portfolios of investors and lenders, perhaps most disastrously in the hospitality sector. A recent American Hotel & Lodging Association report shows the industry lost approximately four million jobs since 2019, and predicted business travel (the largest source of hotel revenue) will recover slowly from current virtually non-existent...

  • Q1 2021 Earnings Roundup: Biologics and Biosimilars Update

    Below are some highlights from first quarter 2021 earnings reports recently released by biologics and biosimilars companies...

  • NYC Enacts Biometric Data Disclosure Rules and Restrictions

    Millions of vaccinated Americans — now maskless — surely can’t wait to rekindle their love affair with their iPhone’s facial recognition technology. Meanwhile, these same people are probably less eager for the bars, restaurants, and theaters they visit to collect that same facial data and other biometric information without their knowledge and sell it to third parties. Across the U.S., many...

  • A Win for Deal Certainty, Delaware Court of Chancery Orders Closing of Cake Supplier Acquisition

    A Win for Deal Certainty, Delaware Court of Chancery Orders Closing of Cake Supplier Acquisition; Under Armour to Pay $9M to Settle SEC Charges Involving Disclosure Failures; First Circuit Upholds Decision Applying Federal Securities Laws to Solicitation of Foreign Investors; Delaware Court of Chancery Applies Business Judgment Rule in Dismissing Buyout Action Against Icahn.

  • Viatris Expects First “Interchangeable” Designation in July 2021 For Insulin Products

    Viatris announced during its Q1 2021 earnings call that its insulin glargine and insulin aspart products are both on track to be approved by the FDA as interchangeable by July 2021. These are proposed biosimilars of Sanofi’s TOUJEO and Novo Nordisk’s NOVOLOG/NOVORAPID products, respectively.

  • Fed Invites Public Comment on Proposed Changes to Durbin Amendment

    In this Issue. The Board of Governors of the Federal Reserve System (Federal Reserve) invited public comment on proposed changes to Regulation II, better known as the Durbin Amendment, regarding network availability for card-not-present debit card transactions; the Securities and Exchange Commission (SEC) Division of Investment Management staff released a statement on funds registered under the...

  • What to Expect from NYC’s Tenant Data Privacy Act

    New York City tenants harboring “big brother” concerns over landlords abusing data collected through smart access (i.e., keyless entry) systems will soon be able to rest easier. Following California, Virginia, and the British Virgin Islands, the New York City Council recently became the latest legislative body to pass privacy legislation with the Tenant Data Privacy Act (“TDPA” or the “Act”). New

  • Bipartisan Legislation Introduced to Increase Access to Biosimilars in Medicare Plans

    On April 26, Representatives Paul D. Tonko (D-NY) and Bob Gibbs (R-OH) introduced the Star Rating for Biosimilars Act. The proposed legislation would direct the U.S. Department of Health & Human Services (HHS) to evaluate Medicare plans based on whether or not cost-saving biosimilars are available to enrollees and to evaluate Medicare Advantage and Part D plans on access to biosimilar drugs.

  • Alvotech Files Suit Against AbbVie to Invalidate Humira Patent Portfolio

    On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District of Virginia. As readers of this blog may recall, in September 2020, Alvotech USA filed a BLA for AVT02, a biosimilar of AbbVie’s 100 mg/mL citrate-free Humira® formulation.

  • CFPB Sends Notification Letters to Landlords Regarding COVID-19 Evictions

    On May 3, 2021, the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC) sent notification letters reminding the nation’s largest apartment landlords of federal protections in place to keep tenants in their homes and stop the spread of COVID-19. The Notification Letter points to the Centers for Disease Control and Prevention (CDC) eviction moratorium for non-payment of...

  • Huon Announces Prolia Biosimilar

    On April 20, 2021, Korean company Huon Labs announced that it will develop a PROLIA biosimilar using PanGen Biotech’s cell culture and purification technology. PROLIA (denosumab), an Amgen product, is indicated to reduce the risk of facture in patients with osteoporosis with a particular concentration on patients that are postmenopausal women.

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