JONES DAY TALKS®: The CNPV Pilot Program: FDA's High-Speed Lane for Drug Approval
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
Thanks to its scientific skills base, growing prowess in AI and a policy environment that supports rapid clinical trials, China has become one of the world’s leading markets for pharmaceutical innovation. Here we explore how...more
Two recent announcements from the Centers for Medicare & Medicaid Services (CMS) continue to signal the Trump administration’s approach to the Medicare Advantage (MA) program, building on trends first seen in the Contract...more
There has been a recent and sudden uptick in enforcement from federal agencies against medspa prescribers. Specifically, the Department of Justice (DOJ) recently indicted a licensed osteopathic physician for allegedly...more
The US Environmental Protection Agency (EPA) on April 2, 2026 published the draft Sixth Contaminant Candidate List (CCL 6), which for the first time identifies both microplastics and pharmaceuticals as contaminant groups for...more
The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternative to the injection currently on the market....more
In the United States, both patent law and U.S. Food and Drug Administration (FDA) regulations govern the commercial availability of drug products and any potential periods of market exclusivity....more
Corcept owns the patents-in-suit, which claim methods of coadministering mifepristone with a strong CYP3A inhibitor (e.g., ketoconazole) to treat Cushing's syndrome, a disorder that causes excessive cortisol production....more
The Trump administration has moved to impose a 100% tariff on imports of brand-name, patented pharmaceutical products and ingredients, while extending lower rates for jurisdictions that have entered into bilateral agreements...more
The Food and Drug Administration (FDA)’s FY 2027 budget proposal, which is the first fully developed under Commissioner Marty Makary’s tenure, includes a wide-ranging collection of legislative proposals that aim to expand the...more
While federal and state legislators contemplate the next wave of PBM and drug pricing reform, legislatures in Virginia and Ohio have already sent significant legislation addressing prescription drug pricing and pharmacy...more
On April 2, 2026, President Donald Trump issued a proclamation titled “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States” (the Proclamation) under Section 232 of the Trade Expansion...more
Following the Council of the European Union and the European Parliament reaching an agreement in the trilogue negotiations on the so-called Pharma Package in December 2025, the texts of the provisional agreement (comprising a...more
On March 31, 2026, the Food and Drug Administration (FDA) published a notice in the Federal Register requesting information and public comment (RFI) on the use of digital health technologies (DHTs) in clinical investigations...more
On March 30, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced that the U.S. Food and Drug Administration (“FDA”) has approved its denosumab biosimilar, PONLIMSI™ (denosumab-adet). ...more
Consumer demand for GLP‑1 drugs such as Ozempic and Zepbound continues to surge, fueling rapid growth in the market for GLP-1 drugs and compounded GLP-1 products, as well as supplements that are marketed to have similar...more
Find the week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary...more
Key Takeaways - On April 1, 2026, FDA issued a statement reminding 503A pharmacies and 503B outsourcing facilities that compounded drugs qualify for the statutory exemptions under the Federal Food, Drug, and Cosmetic Act...more
Despite the flurry of reform activity throughout the first quarter of 2026, the pace of new PBM regulation and drug pricing reforms shows no sign of tapering off. Instead, both federal and state legislatures continue to...more
On April 2, 2026, exactly one year after the “Liberation Day” tariffs, President Donald Trump issued a Proclamation, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States,” (the...more
The Centers for Medicare & Medicaid Services (CMS) has finalized the calendar year (CY) 2027 Medicare Advantage (MA) and Part D rule, with policies effective June 1, 2026, and applicable to coverage beginning January 1, 2027....more
On April 2, 2026, President Trump announced a Proclamation, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States” (the “Proclamation”), which will impose 100% tariffs on patented...more
The US Food and Drug Administration (FDA) has issued new draft guidance giving drug manufacturers – for the first time – formal guidance on how the agency expects firms to respond to a Form FDA 483 following a drug current...more
Dangerous drugs are far more common than they should be. While pharmaceutical companies have a legal duty to ensure that their drugs are safe for use as marketed, numerous patients suffer serious complications caused by...more
On April 1, the U.S. Food and Drug Administration (FDA) clarified its policies on compounded drugs, including compounded versions of GLP-1 products. Compounders are permitted to produce copies of approved drugs only while...more
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more