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Innovative Insights: Legal Updates in Life Sciences | Third Quarter 2025
ISSUES AND UPDATES
Filing Litigation to Challenge FDA Delays in NDA or BLA Review
Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing Applications (BLAs). But an applicant facing such delay is not without legal recourse—as the Administrative Procedure Act provides a potential remedy when the FDA does not take timely action on an NDA or BLA.
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A Return to Traditional M&A? Insights from First Merger Challenge of Trump Administration’s Federal Trade
In the first merger challenge of the Trump Administration, the U.S. Federal Trade Commission (FTC) recently moved to block the $627 million acquisition of cardiovascular devicemaker Surmodics by private equity firm GTCR BC Holdings (GTCR). While the lawsuit confirms the continuation of aggressive antitrust enforcement under Trump, it appears to break from the Biden Administration’s focus on private equity buyers, proceeding instead along a path focused on more traditional theories of harm.
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Preparing for Pharmaceutical Tariffs: What Industry Can Do To Mitigate Supply Chain Risks
The Trump Administration’s tariff initiatives are expected to have significant effects on the pharmaceutical industry, which has largely operated in a tariff-free environment for decades. Pharmaceutical importers and other industry participants should evaluate a variety of legal and commercial strategies to adjust to the changing regulatory environment.
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The Future is FemTech: Innovation and Investment in Women’s Health
Innovation in FemTech has long been underfunded, under-researched, and underprioritized. Both investors and companies are increasingly recognizing the need for innovation sparking long-overdue growth in this market, though early-stage FemTech companies continue to face significant barriers. While the market potential is clear, realizing it will require not only significant capital, but also continued progress in how we prioritize and value women’s health and wellness.
EXECUTIVE ORDERS AND POLICY UPDATES
In the second and third quarters of 2025, the Trump administration and federal agencies have released a number of executive orders and other regulatory actions with potential impacts for the life sciences industry. Some notable policy activities include most-favored nation drug pricing actions and modifications to policy regarding foreign pharmaceutical manufacturing sites. Many of the below actions remain the subject of ongoing litigation.
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RELEVANT RESOURCES
HHS Pilot Program to Evaluate 340B Drug Pricing Program Rebate Models
European Parliament's New Study on Generative AI and Copyright Calls for Overhaul of Opt-Out Regime
Coming January 2026: CMS Launches AI Program to Screen Prior Authorization Requests for Treatments
EU AI Act: European Commission Publishes General-Purpose AI Code of Practice
White House Issues Executive Orders on AI Action Plan
Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations
DOJ Resumes FCPA Enforcement with New Guidelines (Harvard Law School Forum on Corporate Governance)
CMS Updates Kidney Care Choices Model
U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"
Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data
Medicare's Innovation Center Charts New Direction: Part 2 – Digital Health and AI
Vital Signs: Digital Health Law Update | Spring 2025
EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121
DOJ Criminal Division Announces Priority Enforcement Areas and Publishes Revised Enforcement Guidance
Georgia Limits Liability for Pesticide Manufacturers
Judge Blocks FDA Regulation of Laboratory-Developed Tests
CMS Innovation Center Announces Cost-Saving Restructuring of Value-Based Payment Model Portfolio
EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 120
Innovative Insights: Legal Updates in Life Sciences | First Quarter 2025
Proposed California Legislation Aims to Phase Out Ultra-Processed Foods From School Meals
FDA Directed to Explore Elimination of Food Additive "Loophole"
EU AI Act: First Rules Take Effect on Prohibited AI Systems and AI Literacy
NEWSWORTHY
Government pricing and reimbursement lawyer Stephen Forster joins Jones Day as partner in Washington
Former IRS exempt organizations official Mackenzie McNaughton joins Jones Day
Merck's BRIDION® Hatch-Waxman trial victory on patent term extension issue affirmed at CAFC
Artis BioSolutions acquires Landmark Bio
CARMAT completes €9.7 million share capital increase
Labcorp amends its $700 million accounts receivable securitization facility
LAWYER SPOTLIGHT
Sage Revell, a London-based partner in the Corporate Practice and the Health Care & Life Sciences Group, is a market leader in the life sciences and technology sectors. She advises on national and cross-border mergers and acquisitions, venture capital, private equity, and corporate reorganizations. Sage represents emerging-growth companies and the investors who support them from the start-up phase, through growth stages, and all the way through to exit. Click here to see Sage discuss the latest in FemTech, "innovations in women's health at the intersection of life sciences and technology."
