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Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated January 13, 2025

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more

Gardner Law

Breaking the Ice: FDA-focused firm leader sees benefits in AI

Gardner Law on

Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations. ...more

Dechert LLP

Minimum HSR Reporting Threshold Climbs to US$126.4 Million

Dechert LLP on

The minimum size-of-transaction threshold will increase from US$119.5 million to US$126.4 million, a more modest percentage increase than in recent post-pandemic years. Annual adjustments to dollar-based HSR reporting...more

Foley & Lardner LLP

Non-Competes: New Limits for Pennsylvania Health Care Practitioners

Foley & Lardner LLP on

Pennsylvania’s new law, the Fair Contracting for Health Care Practitioners Act (the Act) went into effect on January 1, 2025. This law restricts the ability of employers and health care practitioners to enter into non-compete...more

Dechert LLP

New Names Rule FAQs Released Following Rule Amendments

Dechert LLP on

The staff of the SEC Division of Investment Management (Staff) released updated answers to frequently asked questions (FAQs or 2025 FAQs) about recent Amendments to the Names Rule on January 8, 2025. The FAQs address certain...more

Ballard Spahr LLP

American Bankers Association, state affiliates ask Trump to halt regulatory actions pending a review

Ballard Spahr LLP on

In a letter to President-Elect Donald Trump, the American Bankers Association and its 52 affiliates are calling for a halt to all regulatory actions affecting banks and an extension of all effective dates for final...more

Foley & Lardner LLP

NHTSA Adopts Final Rule to Formalize its Whistleblower Program under the Motor Vehicle Safety Whistleblower Act

Foley & Lardner LLP on

On December 17, 2024, the National Highway Traffic Safety Administration (“NHTSA” or “Agency”) adopted a final rule to formalize its whistleblower program under the Motor Vehicle Safety Whistleblower Act (Whistleblower Act). ...more

King & Spalding

Treasury and IRS Issue Final Regulations Implementing Section 45V Clean Hydrogen Production Tax Credit

King & Spalding on

On January 3, 2025, the IRS and Treasury issued long-awaited final regulations (the “45V Final Regulations”) implementing the clean hydrogen production tax credit (the “45V Credit”) under Section 45V of the Internal Revenue...more

ArentFox Schiff

Navigating the Complexities of Pay Transparency Legislation

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Employers are paying close attention to pay transparency laws, which are the latest trend in employment legislation. Often expanding on existing pay equity laws, many state and local governments have enacted or proposed...more

Troutman Pepper Locke

Retailers Tap Into Pricing & Data to Boost Cigar Sales

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Bryan Haynes, a partner in Troutman Pepper Locke’s Tobacco + Nicotine Practice Group, was quoted in the January 10, 2025 Convenience Store News article, “Retailers Tap Into Pricing & Data to Boost Cigar Sales.”...more

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

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Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Seyfarth Shaw LLP

New Year, New Penalties: OSHA and USEPA Increase Penalties

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The federal Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (“EPA”) have published their 2025 increases to civil penalties....more

Ballard Spahr LLP

HHS Proposes Significant Updates to HIPAA Security Rule

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On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more

Pillsbury Winthrop Shaw Pittman LLP

Meeting Your 2024 Annual Children’s Television Programming Reporting Obligations

The deadline to file the 2024 Annual Children’s Television Programming Report with the FCC is January 30, 2025, reflecting programming aired during the 2024 calendar year. In addition, commercial stations’ documentation of...more

Troutman Pepper Locke

Court Rules Against Banco San Juan Internacional, Inc. in Master Account Dispute

Troutman Pepper Locke on

On January 8, the United States District Court for the Southern District of New York dismissed the claims brought by Banco San Juan Internacional, Inc. (BSJI) against the Federal Reserve Bank of New York (FRBNY) and the Board...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Odor/Air Enforcement: Massachusetts Attorney General Files Judicial Action Against Grafton Animal Feed Dehydrator Operation

The Massachusetts Attorney General (“AG”) on behalf of the Commonwealth of Massachusetts filed on October 16th a civil action in the Superior Court alleging that: …Feedback Earth, Inc. (“Feedback Earth”) is generating...more

Buchalter

Wildfires and the Workplace: What California Employers Must Know to Ensure Safety and Compliance

Buchalter on

The devastating wildfires in Los Angeles area continue to profoundly impact our community, presenting complex challenges for employers and the workforce. As evacuation orders, curfews, and hazardous conditions persist, it is...more

King & Spalding

FTC Announces 2025 Jurisdictional Threshold Updates for Interlocking Directorates and HSR Filing Thresholds

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On January 10, 2025, the Federal Trade Commission (FTC) announced revised jurisdictional thresholds for determining whether a proposed transaction must be reported to federal authorities under the Hart-Scott-Rodino (HSR)...more

IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

Allen Matkins

The CTA Is Dealt Another Blow

Allen Matkins on

As has been widely reported, U.S. District Court Judge Amos L. Mazzant in early December of last year preliminarily enjoined the CTA and its implementing regulations.  Texas Top Cop Shop, Inc. v. Garland, 2024 WL 5049220...more

Skadden, Arps, Slate, Meagher & Flom LLP

Cryptoasset Staking Excluded From the UK Fund Compliance Regime

On 8 January 2025, the UK’s HM Treasury issued a statutory instrument amending the scope of “collective investment schemes” (the Amendment) under the Financial Services and Markets Act 2000 (Collective Investment Schemes)...more

Sheppard Mullin Richter & Hampton LLP

CFPB Finalizes Rule Removing Medical Bills from Credit Reports

On January 7, 2025, the CFPB announced the finalization of a rule amending Regulation V, which implements the Fair Credit Reporting Act (FCRA), 15 U.S.C. § 1681 et seq., to prohibit the inclusion of medical bills on credit...more

Woods Rogers

Department of Labor’s AI Best Practices: Key Takeaways for Employers

Woods Rogers on

In October 2024, the Department of Labor released its principles and best practices for developers and employers using AI (pdf), aiming to provide employers with guidelines to promote workplace augmentation through the use of...more

McDermott+

McDermott+ Check-Up: January 10, 2025

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119th Congress Begins. The new Congress began with key membership announcements for relevant healthcare committees. Cures 2.1 White Paper Published. The document outlines the 21st Century Cures 2.1 legislative proposal,...more

Burr & Forman

Failure to Return Credit Balances (Especially to Medicare and Medicaid) Can Create Significant Liability

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Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more

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