Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 262: Breaking the “Undruggable” Barrier with Marcel Frenkel of Ten63 Therapeutics
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
On 11 December 2025, the Council and the European Parliament reached agreement on the EU Pharma Law Package, also known as the General Pharmaceutical Legislation. No text has been published yet. The agreement will need to be...more
The landscape surrounding Colorado’s healthcare malpractice damage caps continues to shift. Earlier this year, the Colorado General Assembly enacted wholesale changes to the Health Care Availability Act (HCAA). These changes...more
In Williams v. Bally Management Group, LLC, the US District Court for the District of Rhode Island became the first court to grant a motion to dismiss in a class action challenging Bally Management Group’s (Bally) tobacco...more
Below is this week’s congressional update by BakerHostetler’s Federal Policy team. We’ll continue to post in weeks when both chambers of Congress are in session....more
FDA has published a proposed administrative order to include bemotrizinol (BEMT) as an active ingredient in over-the-counter (OTC) sunscreen products under the U.S. sunscreen monograph. The list has remained largely unchanged...more
The U.S. Department of Justice (DOJ) has escalated its criminal enforcement efforts with the formation of the new Health & Safety Unit (HSU) within its Criminal Division’s Fraud Section, effective December 2, 2025. ...more
The U.S. Food and Drug Administration (FDA) announced the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or “TEMPO pilot,” on December 5, 2025, alongside a Federal Register notice seeking...more
U.S. Senators Sheldon Whitehouse (D-RI) and John Barrasso (R-WY) have introduced bipartisan legislation to expand access to high-quality, coordinated health care. The ACO Assignment Improvement Act aims to increase...more
Two and a half years after the initial proposal, agreement has been reached by the EU institutions on the so-called EU Pharma Package. The Package represents a comprehensive overhaul of the European Union’s pharmaceutical...more
The holidays arrive each year with that familiar blend of anticipation, nostalgia, and — if we are being honest — a fair amount of anxiety. For members of the Sandwich Generation, that pressure can feel magnified....more
Senate votes on dueling healthcare bills. Although neither bill passed, some moderate House Republicans continue to try to find a path forward on the expiring enhanced advanced premium tax credits (APTCs), with Speaker...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
In 1995, the Michigan Legislature enacted its Drug Immunity Law, which provided an absolute defense for pharmaceutical companies in product liability suits stemming from the safety and efficacy of their drug products, the...more
This morning, the Alabama Medical Cannabis Commission voted unanimously to issue dispensary licenses to four applicants. Absent a stay entered by a court or the commission, three of those licenses will be issued on January 8,...more
Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver – and...more
On December 2, 2025, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Seagen Inc. v. Daiichi Sankyo Company Ltd., which further clarifies the amount of disclosure a US patent must contain...more
Effective January 1, 2026, all Durable Medical Equipment, Prosthetic Devices, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers will be subject to the Centers for Medicare & Medicaid Services (CMS) 36-month rule...more
A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more
Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more
Republican leaders in the House released the text of their latest healthcare legislation, which would not extend the advanced premium tax credits (APTCs) that are set to expire on December 31, 2025....more
On December 2, 2025, Sarepta Therapeutics filed three petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to the characterization of recombinant adeno-associated virus (rAAV) vector preparations....more
Rule 45(c) of the Federal Rules of Civil Procedure protects witnesses from being compelled to travel long distances to testify at trial by placing geographical limits on the court’s subpoena power....more
The U.S. District Court for the Northern District of California recently certified a narrow damages class under ERISA and RICO in L.D. v. United Behavioral Health, a case involving allegations of inflated balance-billing...more
The U.S. Food and Drug Administration (FDA) on Dec. 11, 2025, announced a proposed administrative order to add bemotrizinol as a new active ingredient to the over-the-counter (OTC) sunscreen monograph. This is the first new...more
Recorded live at the NCLifeSci 2025 Annual Meeting, Marcel Frenkel, co-founder and CEO of Ten63 Therapeutics, joins hosts Heather Matthews and Lauren DeMoss for an exciting conversation about the future of drug discovery....more
