False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more
On July 16, 2025, Bio-Thera Solutions and Accord announced the FDA acceptance of their aBLA for BAT2506, a proposed biosimilar of Janssen / Johnson & Johnson’s Simponi® (golimumab). ...more
On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI®...more
On March 3, 2025, Fresenius Kabi and Formycon announced the launch of Otulfi™ (ustekinumab-aauz), a provisionally interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), subject to the...more
On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Celltrion previously reached a settlement agreement...more
On July 24, 2024, Bio-Thera Solutions announced the FDA acceptance of its aBLA for BAT2206 (ustekinumab), a proposed biosimilar of Janssen and Johnson & Johnson’s Stelara® (ustekinumab), with a request for interchangeability....more
I read the Lewandowski v. Johnson & Johnson class action complaint and couldn’t help but wonder – are plans and participants doomed, or can employers take proactive steps to satisfy their fiduciary duties and potentially...more
Under the Consolidated Appropriations Act of 2021 (“CAA”), employer-sponsored group health plans, including medical-only plans, must submit information about their prescription drugs and health care spending. This submission...more
Many medical benefit plan fiduciaries contract with pharmacy benefit managers (“PBMs”) to administer the prescription drug portion of their health plans, placing the PBM in charge of day-to-day management of the programs....more
The first complaint was filed in what is expected to be a wave of litigation alleging breach of fiduciary duty in selecting and monitoring welfare plan vendors. While the facts of this particular case may make it somewhat...more
On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more
A novel proposed class action lawsuit was filed against Johnson & Johnson (J&J) earlier this month by a current employee for mismanagement of prescription drug prices. The lawsuit alleges, among other things, that J&J...more
On December 7, 2023, a group of health insurers and health insurance administrators filed a class action complaint against Johnson & Johnson and Janssen Biotech, Inc. (collectively “J&J”) in the Eastern District of Virginia...more
States, counties, and cities within weeks could start to receive desperately needed money to battle the deadly opioid abuse and overdose crisis as part of a newly finalized, $26 billion settlement with the largest...more
The past year saw several attempts to apply new applications of the public nuisance doctrine to the opioid crisis. While in the past, public nuisance claims typically sought recovery for damages in connection with land use in...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
On November 9, 2021, the Oklahoma Supreme Court set aside a $465 million verdict against Johnson & Johnson (J&J) in State ex rel. Hunter v. Johnson & Johnson, 2021 OK 54. In 2017, the State of Oklahoma sued three opioid...more
On November 9, 2021, the Oklahoma Supreme Court in State ex rel. Hunter v. Johnson & Johnson, No. 118474, 2021 WL 5191372 (Okla., Nov. 9, 2021), overturned a $465 million verdict against opioid manufacturer, Johnson & Johnson...more
Public nuisance claims have long been understood to rest on “an unreasonable interference with a right common to the general public.” Typically, litigation sought recovery for damages in connection with (among other...more
On July 20, 2021, after nearly four years of litigation, Johnson & Johnson (J&J) and Pfizer have agreed to dismiss all claims asserted in the antitrust suit brought by Pfizer in the Eastern District of Pennsylvania regarding...more
Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits - in settling claims over distributors...more
Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: J&J Settles Opioid-Related New York Suit for...more
Over the last two months, McKinsey & Company — one of the world’s largest consulting firms — resolved matters with all 56 state attorneys general regarding investigations into its role in providing marketing and consulting...more
Walmart and Johnson and Johnson, two of America’s corporate titans, each acted in ways that helped to fuel the opioid crisis that federal experts estimate claims 128 Americans’ lives each day, news media investigations show....more