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Legal Intelligence

"Precision Insights for Legal Updates"

Legal Intelligence Report

# Opening

Recent legal developments reflect a complex landscape across various sectors, including immigration, healthcare, workplace compliance, advertising, and international trade. Notably, changes in social media screening practices for visa applicants and amendments to workplace laws underscore heightened scrutiny in regulatory frameworks. The approval of biosimilars by the FDA further exhibits innovation in the healthcare industry, reflecting ongoing transformations in therapeutic alternatives and market competitiveness. This summary provides a detailed analysis of these key legal developments, regulatory changes, landmark case outcomes, and emerging trends affecting various industries.

# Key Legal Developments

A significant update in immigration policy is the expanded social media screening requirements for H-1B and H-4 visa applicants, which aim to enhance national security by scrutinizing applicants' online activities more rigorously. This shift indicates a growing tendency among U.S. immigration authorities to incorporate digital footprints as part of the vetting process, potentially affecting the approval rates for various visa applications. Stakeholders, including employers and legal advisers, must prepare to navigate the implications of this development, which could lead to increased processing times and require more comprehensive documentation from applicants.

In the healthcare sector, the FDA's recent approval of Lupin’s biosimilar pegfilgrastim (ARMLUPEG) signifies a critical advancement in providing cost-effective treatment options for patients undergoing chemotherapy. The introduction of biosimilars into the market not only challenges existing patented medications but also highlights the agency's push for competition and accessibility in drug pricing. Similarly, Sandoz's launch of Tyruko®, the first U.S. biosimilar to Tysabri®, adds to the expanding portfolio of biosimilars, indicating the pharmaceutical sector's focus on innovation and consumer affordability in the face of rising healthcare costs.

# Regulatory Changes and Compliance Updates

The Illinois legislature has amended the Workplace Transparency Act, which will take effect on January 1, 2026, mandating increased transparency regarding workplace harassment and discrimination issues. Employers are tasked with adapting current policies and protocols to align with these new requirements, potentially affecting how organizations address internal complaints and training options. Organizations must ensure they communicate these changes effectively and revise their employee handbooks to avoid future liabilities under the amended law.

In the realm of advertising and marketing compliance, recent guidance on claims substantiation has emerged, providing crucial takeaways on the necessity of transparency and accuracy in advertising. Businesses need to be vigilant in substantiating any claims made in advertisements to mitigate risks of regulatory enforcement actions from entities like the Federal Trade Commission (FTC). Proper documentation and consistent compliance training will be essential for companies looking to navigate this evolving landscape.

# Notable Case Outcomes and Implications

In a recent landmark case, the Elanco vs. TDF litigation emphasized the limitations of relying solely on trusted advisors for compliance guidance. The ruling underscored the necessity for companies to have robust internal review processes rather than depending exclusively on external advisors. This case serves as a cautionary tale for companies in the life sciences sector, prompting a reevaluation of compliance strategies to include proactive measures in risk management.

# Industry-Specific Legal Trends

Current trends in workplace law signal an increasing emphasis on employee rights and protections, catalyzed by legislative changes like Illinois' Workplace Transparency Act amendment. Companies across numerous sectors are likely to face greater scrutiny regarding workplace conduct policies and employee engagement practices. Additionally, compliance with evolving advertising claims substantiation requirements poses challenges across various industries as businesses strive to maintain legal standards while enticing consumers.

# Action Steps

- **For Employers**: Review and revise current workplace policies to align with the amended Illinois Workplace Transparency Act.

- **For Immigration Attorneys and Employers**: Prepare for increased requirements related to social media screening of visa applicants and educate stakeholders on implications.

- **For Healthcare Providers and Pharmaceutical Companies**: Stay informed about updates in biosimilar approvals and regulations to leverage market opportunities effectively.

- **For Marketing Teams**: Implement stringent procedures for claims substantiation to prepare for regulatory scrutiny in advertising practices.

Key Developments

📝 Other
Expanded Social Media Screening for H-1B and H-4 Visa Applicants

The Department of State has announced that, effective December 15, 2025, all H-1B and H-4 visa applicants will be subject to an online presence review, expanding a requirement previously limited to F, M, and J student and exchange visitor applicants....By: Benesch

Jurisdiction: Department of State
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📝 Other
FDA Approves Lupin’s Pegfilgrastim Biosimilar, ARMLUPEG

Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne).  ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled syringe presentation, referencing Amgen’s NEULASTA. ...By: Goodwin

Jurisdiction: FDA
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📝 Other
Illinois Amends the Workplace Transparency Act Effective January 1, 2026 - Tips for Employers

Illinois has enacted significant amendments to the Workplace Transparency Act (WTA), effective January 1, 2026, that will materially affect employment, separation, and settlement agreements with Illinois employees, applicants, contractors, and consultants....By: Ogletree, Deakins, Nash, Smoak & Stew

Jurisdiction: Unknown
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📝 Other
Sandoz Launches Tyruko® (natalizumab-sztn), First U.S. Biosimilar to Tysabri®

On November 17, 2025, Sandoz and Polpharma announced the U.S. launch of Tyruko® (natalizumab-sztn), the first and only FDA-approved biosimilar to Biogen’s Tysabri® (natalizumab) and the first biosimilar available to treat multiple sclerosis (MS) in the United States....By: Venable LLP

Jurisdiction: FDA
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📝 Administrative
FIFRA Enforcement: 2025 Year-End Roundup and Looking Forward to 2026

Robust U.S. Environmental Protection Agency (EPA) enforcement under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) continued throughout 2025, marked by several high-value settlements—particularly involving antimicrobial pesticides and pesticide devices—and a steady cadence of admini

Jurisdiction: EPA
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📝 Other
Investissement étranger au Canada : Tendances récentes et perspectives

La Loi sur Investissement Canada (la « LIC ») s’applique à tous les investissements effectués au Canada par des investisseurs non canadiens. L’approche du gouvernement du Canada relativement à l’examen des investissements est en évolution. Alors que les examens réalisés avant la clôture de certains

Jurisdiction: Unknown
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📝 Other
Party Time! Do You Have to Pay Employees to Attend a Holiday Party?

As employers prepare to celebrate the holiday season with their teams, wise HR professionals will consider whether their non-exempt employees must be paid for their time at a holiday party....By: Woods Rogers

Jurisdiction: Unknown
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📝 Other
5 Key Takeaways | The Essentials of Advertising Claims Substantiation

Kilpatrick’s Barry Benjamin and Bryan Wolin were honored to participate in the firm’s long-running IP Innovation webinar series, with a presentation on December 3, 2025, covering the essentials of advertising claims substantiation....By: Kilpatrick

Jurisdiction: Unknown
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📝 Other
U.S.–Canada Tariffs: Timeline of Key Dates and Documents (December 2025)

Detailed Timeline - January 20, 2025 - Trump Administration’s America First Trade Policies - U.S. presidential memorandum “America First Trade Policy” outlines trade priorities of the new Trump administration and directs departments to complete various studies by April 1, 2025....By: Blake, Cass

Jurisdiction: Unknown
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📝 Other
When “Trust the Advisor” Isn’t Enough: Lessons from the Elanco TDF Case

I’ve always said, “You’re only one rigorous process away from averting a major fiduciary failure.” It’s one thing to trust your advisors — but completely another to delegate without oversight. So when I saw the article in NAPA – National Association of Plan Advisors titled “Suit Says Plan Sponsor ‘U

Jurisdiction: Unknown
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Last updated: December 9, 2025 at 12:58:54 PM

Key Developments