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Goodwin

Eli Lilly Files Suit Challenging the FDA’s Drug Classification of Retatrutide

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​​​​​​​On September 3, 2024, Eli Lilly filed a complaint against the FDA in the District Court for the Southern District of Indiana pursuing the latest challenge to the FDA’s application of its “biological product”...more

American Conference Institute (ACI)

FCPA, Export Controls, and Sanctions Enforcement: Adjusting Compliance Strategies for the New Normal

As the interplay between export controls, trade sanctions, and anticorruption enforcement continues to intensify, multinational companies must remain vigilant in ensuring that their compliance programs address the many...more

Manatt, Phelps & Phillips, LLP

Health AI Current “State” - All Eyes on California

Those following artificial intelligence (AI) legal developments are closely watching California, which currently has four bills pending the Governor’s signature that will impact AI development and use. California is at the...more

Epstein Becker & Green

United States’ Complaint-in-Intervention Highlights Continuing Effort to Use the False Claims Act to Pursue Alleged Cybersecurity...

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In August, the United States filed a Complaint-in-Intervention in a False Claims Act (FCA) whistleblower suit alleging that the Georgia Institute of Technology (“Georgia Tech”) and an affiliate, Georgia Tech Research Corp....more

Nelson Mullins Riley & Scarborough LLP

Rooker-Feldman Doctrine Doesn't Prevent Certain Bankruptcy Court Decisions

In an opinion issued on Sept. 20 by the United States Bankruptcy Court for the District of New Mexico, Judge David T. Thuma held that the Rooker-Feldman doctrine does not prevent a bankruptcy court from determining whether...more

Lewis Roca

The Importance of Retaining a Grandfathered Gaming Location in Nevada

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We have all heard the phrase location, location, location. In the context of gaming in Nevada, grandfathered locations refer to casinos or gaming establishments that have been allowed to continue operations under previous...more

Bradley Arant Boult Cummings LLP

No 5. OSHA Can Issue Citations for Unsafe Work Conditions That Have Not Resulted in an Employee Injury

Most frequently, employers do not hear from OSHA unless they report a workplace injury. When a reported workplace injury does occur, OSHA will perform a walkthrough inspection of the worksite and may ultimately issue a...more

Bradley Arant Boult Cummings LLP

Senate Proposal Would Weed Out Prior Marijuana Use for Federal Job Applicants

The DOOBIE Act – yes, you read that correctly – could soon become law. While the law isn’t as fun as it might sound to certain cannabis enthusiasts, it would substantially change the hiring practices of the federal government...more

Maynard Nexsen

7 (Other) Reasons to Intervene in Bid Protests: What Awardees Need to Know

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With just a week to go in FY24, federal agencies are rushing to spend those "use it or lose it" dollars. And while there are a number of reasons that support filing a bid protest when you're an unsuccessful offeror – this...more

McDermott+

Healthcare Preview for the Week of: September 23, 2024

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One More Week Until Election Recess - The House and Senate are in Washington, DC, for one more week before leaving until after election day. Over the weekend, congressional leaders struck a deal on a continuing resolution...more

Holland & Knight LLP

CMS Releases Final Rule on the Medicaid Drug Rebate Program

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The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more

A&O Shearman

Federal Circuit Clarifies That The Meaning Of A Claim Term Can Vary While Still Remaining Consistent

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On September 16, 2024, the United States Court of Appeals for the Federal Circuit (“CAFC”) issued an opinion vacating and remanding a decision from the District Court of Minnesota which held the asserted claims of medical...more

Akin Gump Strauss Hauer & Feld LLP

USPTO Director Cracks Down on Patent Owner for Withholding Data and Imposes Severe Sanctions

The Director of the USPTO initiated sua sponte review of a PTAB panel’s decision to impose sanctions based on patentee’s conduct during IPR proceedings.The PTAB cancelled all of patentee’s claims, including those not...more

UB Greensfelder LLP

FINRA Examiners Are Unfairly Manipulating Non-Complaining Customers To Trigger Complaints

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I have watched enough medical shows over the years, from the awesome St. Elsewhere to the never-ending Grey’s Anatomy, to have heard umpteen times that the Hippocratic Oath includes the admonition that doctors “do no harm.” ...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – AI safety global summit, deepfake crackdown, EU AI regulation criticism, and more

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Latham & Watkins LLP

Ruling Requires South Korean Government to Review Climate Targets

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South Korea’s Constitutional Court has issued a “first of its kind” decision in Asia, requiring South Korea to update its greenhouse gas reduction targets. On 29 August 2024, South Korea’s Constitutional Court (the Court)...more

Tucker Arensberg, P.C.

A Guide to Selling Ready-to-Drink Cocktails in Pennsylvania

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On July 17, 2024, Pennsylvania Governor Josh Shapiro signed Senate Bill No. 688 into law, now known as Act 86 of 2024. This legislation introduces a major change to the state’s liquor laws by permitting the sale of...more

DLA Piper

Food and Beverage News and Trends - September 2024 #2

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape....more

Erise IP

What’s Trending in Trademarks: September 2024

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Every month, Erise’s trademark attorneys review the latest developments at the U.S. Patent and Trademark Office, in the courts, and across the corporate world to bring you the stories that you should know about: Meghan...more

Rivkin Radler LLP

HRSA to J&J: Cease Implementation of New 340B Rebate Model

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As previously discussed , Johnson & Johnson (J&J) recently announced its intention to change its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of STELARA...more

Brownstein Hyatt Farber Schreck

Federal and State Regulators Increase Scrutiny of Casino AML Practices

Recent money laundering-related enforcement actions targeting casinos by both the U.S. Department of Justice (“DOJ”) and state regulators suggest increasing scrutiny of anti-money laundering (“AML”) compliance efforts within...more

Seyfarth Shaw LLP

California Mandatory Climate Disclosure Laws Move Forward With Little Concession

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Seyfarth Synopsis: As discussed in our prior legal update available here, in 2023, California enacted two laws that mandate certain climate-related emissions disclosures and financial risk reporting for thousands of public...more

Troutman Pepper

Amendments Align Pennsylvania’s Breach Notification Law With Majority of States

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Earlier this year, Governor Josh Shapiro signed amendments to Pennsylvania’s Breach of Personal Information Notification Act (BPINA) into law, which go into effect on September 26. As part of the implementation of these...more

Hall Benefits Law

Fifth Circuit Rules ACA Preventive Mandate Remains in Effect Nationwide – Except as to Plaintiffs

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The U.S. Court of Appeals for the Fifth Circuit has ruled in favor of Christian-owned businesses and individuals who sued over the Affordable Care Act (ACA) preventive care mandates. The appellate Court agreed with the...more

Williams Mullen

PODCAST: Williams Mullen's Raising Capital 101: A Securities Podcast - What Makes it a Securities Offering?

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On this episode of Raising Capital 101, host Tom Voekler is joined by special guest, Mike Beville of Beville Properties and colleagues Rhys James and John Watson to discuss if it matters who invests in your company? Does it...more

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