12 Days of Regulatory Insights: Day 7 – Tobacco and Nicotine Regulatory Roundup — Regulatory Oversight Podcast
Navigating FDA's 2025 AI Guidance: Risk-Based Framework, Public Comments, and Generative Models - The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 261: Transforming Lives with Advanced BioMaterials with Dr. Juliana Blum of BioAesthetics
The Down-Low on Data for Value-Based Enterprises and Their Participating Providers – Diagnosing Health Care Video Podcast
The Corner Series Podcast: Scaling Medical Aesthetics
The Corner Series Podcast: Patent Investment Strategies
The Corner Series Podcast: Integration Over Aggregation in Oral Surgery
Early-Stage Spotlight - Kyha's Approach to Women's Health — PE Pathways Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 260: Innovation and Policy in Animal Health with Ron Phillips of the Animal Health Institute
The Corner Series Podcast: Site-of-Care Optimization
The Corner Series Podcast: Equipping PE Partners With Services for Success
The Corner Series Podcast: Rooting Out Bad Actors in Private Equity
The Corner Series Podcast: State Regulatory Interventions in Healthcare
The Corner Series Podcast: Proving Private Equity’s Value in Healthcare
The Corner Series Podcast: From Transactions to True Impact
The Corner Series Podcast: Tracking the Fast-Growing Payor Services Market
The Corner Series Podcast: Private Equity Partnerships and Market Trends
The Corner Series Podcast: Shedding Light on Healthcare Compliance
The Corner Series Podcast: Life Sciences Investors: Keep These Developments Top of Mind
12 Days of Regulatory Insights: Day 2 – How AGs Are Shaping Health Care Markets — Regulatory Oversight Podcast
A Missouri lawmaker just introduced a bill that would invalidate non-compete agreements for licensed physicians if it gets approved by the legislature and is ultimately signed into law. The proposal, sponsored by state Rep....more
Canada’s Drug Agency (CDA-AMC) published data on Canada’s drug system as part of the Data Systems and Analytics program. The new data cover the following information for oncology and non-oncology drugs from 2020-2024...more
In our previous legal update last month, we outlined language included in one of the appropriations bills which was passed in connection with ending the historic government shutdown. The package contained language that, among...more
On 27 November 2025, Commission Decision (EU) 2025/2371 of 26 November 2025 declaring the functionality of the first four EUDAMED modules was published in the OJEU. ...more
On December 1, the Centers for Medicare & Medicaid Services (CMS) announced the Advancing Chronic Care with Effective, Scalable Solutions Model (ACCESS), a 10-year voluntary alternative payment model (APM) that will pay...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, we check in on developments in Nebraska. The Congressional Research Service releases a report on the...more
Find this 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...more
Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord. ...more
After the Council of the European Union (Council) adopted its negotiation position on the so-called Pharma Package in June 2025, the Council and the European Parliament have now reached an agreement in the trilogue...more
The Centers for Medicare & Medicaid Services (“CMS”) final rule for Medicare payment for services provided in hospital outpatient departments (paid under the Outpatient Prospective Payment System or “OPPS”) and ambulatory...more
ERISA class action litigation did not let up in 2025. Retirement plan fee litigation – which has dominated for several years – remained steady, with new, or in some cases refined, theories targeting 401(k) forfeitures and...more
On December 4, 2025, the FDA approved a new indication for Bristol Myer Squibb’s BREYANZI (lisocabtagene maraleucel) for the treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed...more
West Virginia AG J.B. McCuskey, assisted by private outside counsel, filed a federal lawsuit against Optum Inc., United Healthcare’s pharmacy benefit manager, and several affiliated entities, alleging that Optum exacerbated...more
It was brought to the attention of the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) that healthcare providers may be violating HIPAA in certain instances where they deny parental access to a...more
As kids woke to naughty elves on their shelves on 1 December, ministers also provided UK-based pharmaceutical companies a shot-in-the-arm behind door #1 of their advent calendars. The UK government announced on Monday, 1...more
Healthcare entities face increasing scrutiny as states tighten rules on who can own and operate medical practices. With new legislation taking effect in Oregon and California on January 1, 2026, understanding the Corporate...more
T-21 Days Until the Expiration of the ACA eAPTCs: On Thursday, the Senate is expected to vote on a proposal from Democrats that would extend the expiring Affordable Care Act enhanced premium tax credits (eAPTCs) for three...more
In this episode of our special 12 Days of Regulatory Insights podcast series, Chris Carlson is joined by colleagues Bryan Haynes and Agustin Rodriguez — members of our Tobacco and Nicotine Practice and RISE Practice Group —...more
In this episode of The Good Bot, recorded in August of this year, Brett Mason welcomes FDA regulatory attorney Kyle Dolinsky to unpack the FDA’s January 2025 draft guidance on artificial intelligence in drug and biologic...more
Motivational interviewing (MI) is an evidence-based therapeutic style developed in the early 1980s. While the technique may not come naturally, especially for those of us without a background in clinical or counseling work,...more
Key Takeaways - AI adoption in home health and hospice is accelerating regulatory risk, with Section 1557 nondiscrimination rules, HIPAA obligations, and CMS reimbursement scrutiny creating new exposure around bias, PHI...more
Introduction - Artificial Intelligence (AI) is proliferating across the life science industry, accelerating drug design, diagnostics, personalized medicine, and more. The race to deploy AI technologies can make it tempting...more
Delay in Increased OPPS Payment Reductions to Offset the 340B Lump Sum Remedy - The OPPS Final Rule for 2026 did not include raising the reduction to the OPPS conversion factor from 0.5 percent to 2 percent. The initial 0.5...more
The final FY 2026 National Defense Authorization Act (NDAA) was released on December 7, inclusive of a modified version of the Senate-passed BIOSECURE Act from October. This final bill maintains the core structure of the...more
On November 20, 2025, Consip S.p.A. (the national procurement agency) published a market consultation document on “Innovative healthcare equipment management services.” ...more
