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 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. ...more
Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
COMPETITION & STATE AID - State Aid- Fit for Future Platform pursues simplification of EU law, including Opinion on State aid - On 28 January 2022, the Fit for Future Platform, a high-level expert group to assist the...more
Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an...more
Last week, the EMA authorized Insulin aspart Sanofi’s biosimilar product. The EMA notes on its website that Insulin aspart Sanofi is “highly similar to another biological medicine [NovoRapid] that is already authorized in the...more
Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows...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
The OCC announced yesterday that it’s bringing enforcement actions against five former Wells Fargo bank executives as part of their alleged roles in the bank’s sales practices scandal. The agency further revealed that it’s...more
Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets....more
The EMA will be launching Phase 3 of its business continuity plan on October 1, 2018 at the latest, however, the detail of the plan will now be impacted by the EMA announced this week that it has realized that it will lose...more
Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more
On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more
A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more