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Antitrust Provisions Food and Drug Administration (FDA)

Cozen O'Connor

The State AG Report – 07.10.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • AGs Renew Call for FDA Guidance on Toxic Heavy Metals in...more

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

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On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more

McDermott Will & Emery

FTC Revives Orange Book Listing Challenges

On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in...more

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

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President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more

Akin Gump Strauss Hauer & Feld LLP

Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients (Trump EO Tracker)

This order makes it the policy of the United States to have the most-favored-nation price for prescription drugs and biologics. The order directs the Secretary of Commerce and the United States Trade Representative to take...more

McDermott Will & Emery

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

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The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical...more

Goodwin

How the Trump Administration Could Reshape Regulation in the Life Sciences Sector

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Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more

DLA Piper

Food and Beverage News and Trends - December 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. FSIS moving to strengthen oversight of food processing facilities with focus on...more

King & Spalding

The Trifecta: What to Expect from a Second Trump Administration and a Republican Congress

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Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more

Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

Wilson Sonsini Goodrich & Rosati

[Event] Biotech Summit 2024 - October 9th - 10th, Boston, MA

Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more

Polsinelli

The FTC’s Challenge to the Listing of Device Patents in the Orange Book: What Challenge?

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On September 23, 2023, the FTC issued a policy statement advising it would be putting market participants on notice that it intends to scrutinize improper Orange Book listings to determine whether such actions constitute...more

Knobbe Martens

"Improper” Listing of Patents in the FDA’s Orange Book

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As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

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Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

Skadden, Arps, Slate, Meagher & Flom LLP

Insights – June 2024

Explore the unique considerations for mergers and acquisitions in the AI sector, the return of IPOs, the implications of new Supreme Court decisions and other developments in this edition of Skadden’s quarterly Insights....more

Hogan Lovells

The antitrust perspective on patenting strategies in the life sciences industry

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Antitrust authorities are cracking down on life sciences companies using patenting strategies to delay, block or impede access by competitors to the market. Firms with market power need to be mindful of antitrust when...more

McDonnell Boehnen Hulbert & Berghoff LLP

CVS Pharmacy Inc. v. Forest Laboratories Inc. (2d Cir. 2024)

In a decision characterized (somewhat remarkably) by the Circuit Court as being one of first impression, the Second Circuit affirmed dismissal with prejudice of an antitrust allegation by a class of plaintiffs* against Forest...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy

Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - May 2024

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Second Circuit Affirms “Pay for Delay” Dismissal:  On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more

Foley & Lardner LLP

Master of Its Choice of Forum?

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On April 29, 2024, the U.S. Supreme Court agreed to review whether a plaintiff may compel the remand of a case removed on the basis of federal question jurisdiction by voluntarily amending its complaint to leave only state...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - April 2024

WilmerHale on

This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more

Proskauer - Health Care Law Brief

Public Portal to Promote Healthy Competition

Past long-standing chair of Proskauer’s Health Care Department, Ed Kornreich is a recognized authority on the legal, regulatory and business issues related to health care… Past long-standing chair of Proskauer’s Health Care...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - January 2024

WilmerHale on

Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision.  On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more

Fish & Richardson

Biosimilars 2022 Year in Review

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2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

BakerHostetler

Baby Formula Shortage Subject of FTC Scrutiny

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On May 23, 2022, the Federal Trade Commission (FTC), at the prompting of President Joe Biden, announced that it will launch a civil investigation into the ongoing shortage of baby formula throughout the country. The FTC is...more

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