FDA Approval of Alvotech/Teva Ustekinumab Biosimilar
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab)… more
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson’s STELERA® (ustekinumab)… more
One year ago, the United States Patent and Trademark Office (USPTO) issued an Advance Notice of Proposed Rulemaking (ANPRM) that set forth several ideas related to America Invents Act (AIA) proceedings before the Patent Trial and… more
Today, the Supreme Court of the United States granted certiorari in two cases: Garland v. VanDerStok, No. 23-852: This administrative law and statutory interpretation case concerns the federal government’s ability to regulate… more
Massachusetts regulators have finalized a set of rules covering sports betting operators’ data-privacy obligations. The Massachusetts Gaming Commission (MGC) agreed to several clarifications to its regulations, which were originally… more
Centaurs are mythological creatures with a human’s upper body, and a horse’s lower body. They symbolize a union of human intellect and animal strength. In AI technology, Centaurs refers to a type of hybrid usage of generative AI that… more
The Securities and Exchange Commission (the “SEC”) adopted changes to Rule 15c6-1 under the Securities Exchange Act of 1934, as amended on February 15, 2023, to shorten the standard settlement cycle from T+2 to T+1. See 17 CFR Parts… more
Ohio’s campaign finance reporting deadlines were updated for 2024, please find the latest deadlines and other campaign finance compliance information on the chart here… more
Published in The Air & Space Lawyer, Volume 36, Number 2, 2024 - April 10, 2024 An airframe or engine general terms agreement (GTA) is an umbrella term for any agreement between (a) an entity that has an interest in an airframe or… more
In an article in the Fordham Journal of Corporate and Financial Law, “Minutes Are Worth the Minutes: Good Documentation Practices Improve Board Deliberations and Reduce Regulatory and Litigation Risk,” former Chief Justice of the… more
The JCT Design and Build 2024 contract has now been released, marking the first major update to the JCT Design and Build standard form since 2016. The changes are a lot more significant than the updates made last time around when the… more
On April 12, a unanimous Supreme Court held in Macquarie Infrastructure Corp. v. Moab Partners, L.P. that material omissions are actionable under Section 10(b) of the Exchange Act and its enabling SEC Rule 10b-5 only if the omission… more
On April 18, 2024, the United States Court of Appeals for the Fifth Circuit reversed the dismissal of and reinstated a putative shareholders’ class action against an amusement park company (the Company”) and certain of its executives… more
The recent ANA Advertising Law 1-Day Conference, hosted in Katten’s New York office, included a panel about current legal trends in sports marketing featuring Sports and Sports Facilities Partner Daniel Render and Executive Vice… more
In Bissonnette v. LePage Bakeries, a unanimous Supreme Court clarified the scope of the Federal Arbitration Act’s (FAA’s) “transportation worker” exemption by rejecting the industry-based test applied in the Second Circuit. In doing… more
In Nu Skin Enterprises Inc. v. Raab, the Tenth Circuit Court of Appeals considered the preclusive effect of a state trial court decision as it related to the arbitrability of the parties’ dispute under the Federal Arbitration Act… more
Last week ended with several new developments in the lawsuit challenging the CFPB’s final credit card late fee rule (Rule), both of which appear to reduce the likelihood that the Rule will be stayed before its May 14 effective date… more
On April 19, 2024, the EEOC published in the Federal Register its 125-page final rule implementing the PWFA. The final rule will take effect on June 18, 2024… more
Kidnap and ransom (K&R) insurance is the corporate insurance that no one talks about—for good reason. Telling potential kidnappers that you have such an insurance policy (often referred to as a “special risk” or “special contingency”… more
On March 28, 2024, Brazil’s National Petroleum Agency (ANP) published the mandatory individual targets for reducing greenhouse gas emissions for 2024. These targets consider the global target of 38.78 million Decarbonization Credits… more
Employers should review their handbooks and workplace conduct policies in light of a new development that could greatly expand the penalties for unfair labor practice charges. The NLRB’s General Counsel just issued a memo on April 8… more
Restricted funds are monies donated or bequeathed to a charity or non-profit organization such as a museum that come with limitations imposed by the donor on the investment, management or use of the funds. Examples include a… more
Participants will leave the presentation with an understanding of the impact of technology on the legal industry, the strategic management of technology in legal operations, and the skills necessary to navigate and lead in an evolving… more
Employers should get ready to comply with key workplace changes since New York lawmakers just finalized the state budget. The 2024-2025 budget – which was approved on April 20 – ushers in three significant updates impacting employers… more
The Information Commissioner’s Office (ICO), the UK’s data protection regulator, has published an opinion on age assurance for internet society services (ISS). The opinion aims to explain how a company can use technology in compliance… more
Protecting innovation is more important than ever for energy companies. It is a primary source of competitive advantage, and the product of considerable R&D investment. At the same time, it is often the vehicle for partnership and… more
On April 19, 2024, the U.S. Department of Education’s Office for Civil Rights released its unofficial copy of the final Title IX regulations, a summary of the major final provisions, and a resource for drafting nondiscrimination… more
On April 2, 2024, the Attorney General’s Municipal Law Unit rejected a portion of the Town of Sherborn’s zoning bylaw amendment pertaining to restrictions on battery energy storage systems (“BESS”), but allowed the establishment of a… more
In surprising news for the California county retirement system community, on April 17, 2024, the California Supreme Court granted review of Ventura County Employees’ Retirement Ass’n v. Criminal Justice Attorney’s Ass’n of Ventura… more
Under a new Florida law, employers will need to turn to state and federal agencies – rather than local governments – for guidance on certain key workplace rules. Specifically, Governor Ron DeSantis signed HB 433 on April 11, which… more
Notable litigation filed during March 2024 includes SEC v. Sanchez, et al. and four related actions captioned Dottore v. FC Real Estate Development Co., Dottore v. Kensington Pointe Ltd., Dottore v. Seibert Enterprises, Ltd., and… more
Welcome, readers, to a significant moment in non-compete law. On Tuesday, April 23rd, at 2 p.m. Eastern Time, the Federal Trade Commission (FTC) will convene for a special virtual meeting to address non-compete agreements and announce… more
Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing, or another… more
A recent trade secret case from New York highlights the importance of how damages are calculated and emphasizes the need to conform those damages calculations to the applicable standards in your jurisdiction. In Syntel Sterling… more
On April 16, 2024, the Mine Safety & Health Administration (“MSHA”) released its final rule for Respirable Crystalline Silica (“RCS”) for preliminary viewing, and it was published in the Federal Register on April 18, 2024. While an… more
The New York State 2024-2025 budget includes legislation that extends until July 1, 2026 the independent practice authority for certain qualified nurse practitioners with over 3,600 practice hours… more
Effective April 17, 2024, U.S. Customs and Border Protection (“CBP”) has amended its regulations implementing the Enforce and Protect Act of 2015 (“EAPA”), a statute granting increased authority to investigate allegations of evasion of… more
Just over a year ago, the White House issued its long-awaited National Cybersecurity Strategy, with an emphasis on defending Critical Infrastructure, promoting public and private collaboration, and safeguarding the availability of… more
After much anticipation, New York State lawmakers came to a final agreement on a budget bill, which contains several key changes employers should take note of. Three employment law provisions of Gov. Hochul’s executive budget proposal… more
The U.S. Environmental Protection Agency’s (EPA) new Strategic Civil-Criminal Enforcement Policy, announced last week by David Uhlmann, Assistant Administrator for the Office of Enforcement and Compliance Assurance (OECA), immediately… more
The unanimous opinion holds that development impact fees established through the legislative process are subject to constitutional scrutiny as potential regulatory takings. The Takings Clause of the Fifth Amendment to the US… more
In today's professional services marketing landscape, AI is the hottest topic, leaving many marketers pressured to keep pace with the rapid advancements in their firms' AI strategies. In this episode of the Passle CMO Series… more
Earlier this year, the US Department of the Treasury’s (Treasury’s) Financial Crimes Enforcement Network (FinCEN) published a notice of proposed rulemaking (the Proposal) that would subject investment advisers to anti-money… more
Welcome back to the Bar Exam Toolbox podcast! Today we are excited to speak with Jesse Mecham -- a personal finance expert and founder of You Need A Budget -- about ways to decrease spending and borrowing during bar prep and generally… more
On April 12, 2024, the Consumer Financial Protection Bureau (CFPB) and its director Rohit Chopra asked U.S. District Judge Randy Crane to grant summary judgment and dispense with an industry-backed challenge to the requirement that… more
On April 19, 2024, EPA issued its long-awaited Final Rule officially listing two key per- and polyfluoroalkyl substances (PFAS), or so-called “forever chemicals,” as “hazardous substances” under the Comprehensive Environmental… more
On April 19, 2024, the U.S. Environmental Protection Agency (“EPA” or “the Agency”) released details of its highly anticipated rule listing perfluorooctanoic acid (“PFOA”) and perfluorooctanesulfonic acid (“PFOS”), two forms of per-… more
Welcome back to the Law School Toolbox podcast! Today we're discussing why doing the assigned reading for your law school classes is important, and we address some common questions we receive from students regarding reading cases for… more
Remarks given by Commerce Secretary Gina Raimondo and Undersecretary Alan Estevez during the 2024 Policy Update Conference sponsored by the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) emphasized the need for… more
Express, Inc., the fashion mall retailer, filed for Chapter 11 bankruptcy protection in the District of Delaware Bankruptcy Court, docket #24-10831 (KBO) on April 22, 2024. This is the second retailer bankruptcy filing that… more
On 9 April 2024, the Central Bank of Ireland (the "CBI") issued guidance on the authorisation of payment institutions ("PIs") and Electronic Money Institutions ("EMIs") and the registration of account information service providers… more
On April 15, 2024, the Department of Justice (DOJ) criminal division announced a new pilot program designed to reward individuals with non-prosecution agreements (NPAs) who voluntarily self-disclose "actionable, original information"… more
On April 15, 2024, the Department of Justice (“DOJ”) released an internal memo introducing a Pilot Program on Voluntary Disclosures intended to encourage individuals – from executives to lower-level employees – to report corporate… more
The California Department of Industrial Relations recently released its FAQs regarding the new fast food minimum wage law, AB 1228, which took effect on April 1, 2024. The legislation sets an industry-wide minimum wage for employees… more
On Saturday, April 20, the House voted on a series of five separate bills, three of which would provide emergency funding to Israel, Ukraine and the Indo-Pacific, a fourth so-called “sidecar” spending bill that would cover a series of… more
In today’s rapidly evolving business landscape, compliance and risk management are critical components for the success and sustainability of any organization. With the increasing complexity of regulations and the growing need for… more
Once an agreement of purchase and sale for real estate is signed, the path to closing and the rules of closing are firmly engrained, both in the terms of the contract and in principles of law and equity. You don’t get to unilaterally… more
This month the SEC secured a jury trial victory in its much-discussed “shadow trading” case in SEC v. Panuwat. As we have described in a prior alert, the term “shadow trading” has been used to refer to trading in the securities of one… more
On April 19, 2024, the U.S. Department of Education issued its updated final regulations enforcing Title IX of the Education Amendments of 1972 (“Title IX”), 20 U.S.C. §1681 et seq., which will govern sex discrimination complaints… more