FDA Receives Second Biosimilar Application

The Treasury Department intensifies economic pressure on Iran through Operation Economic Outcast, suspending aviation licenses and sanctioning dozens of entities while implementing a presumption of denial for Iran-related transactions. Meanwhile, new enforcement actions target Chinese cybercrime platforms, Ecuadorian terrorist organizations, and Israeli settlers, as Congress considers comprehensive Russia-Iran sanctions legislation.

The U.S. District Court for the District of Columbia has preliminarily enjoined the Department of War from enforcing WuXi AppTec's Section 1260H designation, finding the agency misread its evidence on state and military affiliation. However, this ruling does not close alternative pathways to biotechnology company of concern (BCC) designation under the BIOSECURE Act, and earlier supply-chain restrictions continue to drive near-term compliance decisions with a critical June 30, 2027 deadline for sub-tier supp

Massachusetts voters will decide nine statewide ballot questions in November 2026 that could fundamentally reshape the state's legal, regulatory, and fiscal landscape. These measures address government transparency, election reforms, housing development, marijuana regulation, firearms laws, and state revenue limits, with implications extending far beyond Election Day to implementation, regulation, and ongoing policy debates.

The Department of Justice announced a $25 million settlement with Accenture Federal Services over allegations that the company violated the False Claims Act by falsely certifying compliance with anti-discrimination requirements while allegedly using race or sex in hiring, promotion, and access to professional development programs. This marks the third major DEI-related FCA enforcement action in 2026, following similar settlements with IBM and Deloitte.

The Lindsey O. Graham Sanctioning Russia and Iran Act of 2026 has become law, imposing sweeping sanctions on Russian officials, financial institutions, and shadow fleet vessels while authorizing tariffs up to 100 percent on major purchasers of Russian oil and natural gas. How will these new measures impact global trade relationships, particularly with China and India as the largest buyers of Russian crude?

Global sanctions enforcement intensifies as the US expands its economic pressure campaigns against Cuba, Iran, and Venezuela while the UK and EU strengthen their Russia sanctions frameworks. Meanwhile, China pushes back against US sanctions targeting its companies over alleged Iran ties, and a Dutch chipmaker faces asset freezes amid a complex ownership dispute involving Chinese courts.

The Department of Justice secured a $2 million settlement with Honeywell Aerospace for allegedly failing to comply with NIST SP 800-171 cybersecurity requirements under a Department of War contract. This case demonstrates how cybersecurity compliance failures can trigger False Claims Act liability even without an actual data breach or cyberattack, and highlights the growing role of whistleblowers in exposing contractors' gaps between contractual obligations and actual security practices.

The Advisory Council on Historic Preservation has advanced a Notice of Proposed Rulemaking that would fundamentally restructure Section 106 of the National Historic Preservation Act, marking the most significant regulatory overhaul in over 20 years. The proposed changes would shift the consultation process from a multi-step framework to an agency-prepared report system, narrow the scope of protected properties, and grant federal agencies greater unilateral authority in resolving adverse effects.

President Trump has nominated Dr. Heidi Overton to lead the FDA, bringing a policy expert with experience in medical marijuana reform, vaccine policy, and drug access initiatives. Her prior positions on mifepristone regulation, childhood vaccination schedules, and pharmaceutical innovation offer insight into potential agency priorities. The nomination faces a contested Senate confirmation process as stakeholders assess how her health policy background may shape FDA's regulatory approach.

The U.S. government has dramatically expanded Iran-related sanctions through new sectoral determinations, entity designations, and the suspension of key authorizations, while simultaneously targeting third-country financial institutions that facilitate Iranian transactions. These measures significantly broaden secondary sanctions risks across aviation, digital assets, gold, shipping, and technology sectors, marking a comprehensive escalation in economic pressure against Iran and its international networks.

The Code is voluntary, but it will likely become an important reference point for demonstrating compliance with Article 50 of the AI Act.

The Ninth Circuit Court of Appeals vacated a preliminary injunction against Perplexity AI, determining that when an AI agent acts at a user's direction, it is the user—not the AI company—who "accesses" computer systems under federal and California computer fraud statutes. This landmark appellate decision addresses how existing computer-access laws apply to agentic artificial intelligence and has significant implications...

The European Commission has proposed replacing the EU's three core procurement directives with a single, directly applicable Regulation that would fundamentally reshape how companies compete for public contracts across Member States. The reform introduces mandatory quality criteria thresholds, embeds ESG considerations as evaluation factors, and establishes new security and European-preference provisions that could restrict participation based on ownership, supply chain exposure, and strategic dependencies.

A federal court has struck down New York's Climate Change Superfund Act, which sought to recover $75 billion from fossil fuel companies based on historical emissions. The ruling found the Act preempted by the Clean Air Act, marking the first judicial decision on state climate superfund legislation and establishing that EPA's rescission of the endangerment finding does not alter preemption analysis.

The European Commission has initiated infringement procedures against 20 EU Member States for failing to transpose the EmpCo Directive by the March 27, 2026 deadline. This directive aims to combat greenwashing by requiring substantiation of environmental claims and third-party certification for sustainability labels, with full implementation expected by September 27, 2026.

Mexico's comprehensive anti-money laundering framework has undergone a sweeping transformation through Acuerdo 115/2026, introducing mandatory risk-based methodologies, enhanced client due diligence protocols, and automated monitoring requirements. With implementation deadlines beginning March 1, 2027, obligated parties conducting vulnerable activities face compressed timelines to overhaul their compliance infrastructure while navigating heightened enforcement risks and stricter beneficial ownership thresho

The European Commission has adopted final Guidelines on exclusionary abuses of dominance under Article 102 TFEU, introducing a "workable effects approach" that narrows presumptions while expanding guidance on objective justifications and recognizing sustainability benefits as valid efficiencies for the first time. These Guidelines replace the 2008 Enforcement Priorities Guidance and are expected to significantly impact enforcement practices across EU Member States and beyond, particularly for digital market

On December 3, a federal court in the Central District of California granted plaintiffs' request for preliminary approval of a proposed $22 million settlement ...

The user of defective goods benefi ts from several causes of action against the vendor or manufacturer.

The IRS has proposed new regulations that would impose nondiscrimination requirements on private schools seeking to maintain their tax-exempt status under section 501(c)(3). These regulations would prohibit policies discriminating on the basis of race, color, or national or ethnic origin in admissions, financial assistance, and other school programs. The proposed rules raise important questions about how private schools can structure their programs while complying with federal tax law requirements.