Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
On May 21, 2025, the Federal Trade Commission (FTC) renewed its efforts to challenge pharmaceutical manufacturers that have allegedly listed patents improperly in the Food and Drug Administration’s (FDA) publication of...more
Cigna filed a lawsuit on June 24 in Manhattan federal court accusing Bristol Myers Squibb of unlawfully blocking generic versions of its blood cancer drug, Pomalyst, from entering the market. The suit also names Celgene, a...more
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
Oregon AG Dan Rayfield settled with AbbVie Inc. and Besins Healthcare, Inc. to resolve allegations that the pharmaceutical companies engaged in anti-competitive conduct relating to the sale of testosterone replacement gel in...more
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more
I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more
The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more
The Antitrust Division has been active – like any aggressive prosecution strategy, however, its results have been mixed. Its record in criminal cases has taken serious hits – a stunning set of losses in the chicken...more
On June 30, 2023, a jury in the Northern District of California found Gilead and Teva not liable in a trial accusing the companies of engaging in an illegal reverse payment to delay generic versions of two HIV drugs, Truvada...more
Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more
The healthcare industry faces cascading risks – one risk flows to another with compounding financial results. Three generic drug companies just experienced this cascading liability. ...more
On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more
The US Court of Appeals for the Fourth Circuit revived an antitrust suit alleging that a pharmaceutical manufacturer illegally maintained its monopoly for its innovator drug by precluding competition beyond the expiration...more
In the much-anticipated Lundbeck case (i.a. C-591/16 P), the European Court of Justice (“ECJ”) on 25th March 2021 confirmed the decision of the European Commission (“Commission”) to impose fines on Lundbeck and several...more
In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts. In two recent rulings – “Lundbeck and...more
The Court of Justice of the European Union (ECJ) has confirmed that pay-for-delay agreements with generic manufacturers ready to enter the market violate EU antitrust rules. ...more
On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices...more
On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more
On October 7, 2019, California became the first state to enact legislation—Assembly Bill 824 ("AB 824")—rendering certain pharmaceutical patent litigation settlement agreements presumptively anticompetitive. This alert...more
On February 25, 2019, in FTC v. Shire ViroPharma, Inc., the U.S. Court of Appeals for the Third Circuit confirmed that the Federal Trade Commission (FTC) cannot plead its way into federal court via Section 13(b) of the FTC...more
On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more
In a novel interpretation of the Federal Trade Commission (FTC) Act, the U.S. District Court for the District of Delaware recently held in FTC v. Shire ViroPharma that the FTC had failed to plead the facts necessary to invoke...more
The Third Circuit Court of Appeals affirmed a Pennsylvania district court decision holding the Eleventh Amendment to the United States Constitution prevented a private party from enjoining the state of Louisiana from bringing...more
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more