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
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 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 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
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
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 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
Multiple sources are reporting that Celltrion is planning to roll out REMSIMA SC, its subcutaneous infliximab biosimilar of Johnson & Johnson’s autoimmune disease treatment REMICADE, in Europe in the first quarter of 2020,...more
Walgreens and Kroger have filed an antitrust action in the United States District Court for the Eastern District of Pennsylvania accusing Johnson & Johnson (J&J) of engaging in anticompetitive conduct designed to stymie the...more
Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls. Below are some highlights...more
Last week, Johnson & Johnson held its earnings call for the fourth quarter of 2017. During the call, company representatives discussed an 8% decline in U.S. sales for Remicade as Johnson & Johnson “continued to compete in the...more
The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more