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
Holiday Gifts in Healthcare: Are You Breaking the Rules?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 259: The Patient Voice in Clinical Trials with Tom Croce of Jazz Pharmaceuticals
Hospice Insights Podcast - But Am I Set Up for Growth: Corporate and Governance Considerations for Growing Hospice
AI Underwriting Uncovered: Risks, Data, and Liability in Insurance – The Good Bot Podcast
HIPAA vs. HR - Where Privacy Meets Employment: What's the Tea in L&E?
AGG Talks: Government Insight for Life Sciences Leaders | How Medicare Regulations Could Affect Access to Gender-Affirming Care: Implications for Life Sciences Companies
42 CFR Part 2 Final Rule: What’s Changing and What Do You Need to Know? – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 257: Biogen’s $2B Investment in North Carolina’s RTP with Nicole Murphy
A diagnosis of T-cell lymphoma after using Dupixent raises serious questions for patients and families. Many want clear answers about whether they may have a legal claim and what criteria determine eligibility. This guide...more
Le 8 novembre 2025, Santé Canada a publié le Règlement modifiant le Règlement sur les instruments médicaux (licences d’établissement) (le « projet de règlement ») dans La Gazette du Canada, lequel propose des changements aux...more
As the U.S. birth rate continues to drop, a growing number of states have passed laws to improve access to fertility treatments, lessen related costs, and grant time off for employees experiencing reproductive losses. This...more
Regulators and lawmakers continue to intensify scrutiny of private equity (“PE”) ownership of healthcare providers and government contractors at both the federal and state levels....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
Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled syringe presentation, referencing...more
On November 17, 2025, Sandoz and Polpharma announced the U.S. launch of Tyruko® (natalizumab-sztn), the first and only FDA-approved biosimilar to Biogen’s Tysabri® (natalizumab) and the first biosimilar available to treat...more
On December 3, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on an Updated Draft Risk Calculation Memorandum (Draft Memorandum) to inform a revised draft risk...more
In complex commercial agreements, parties are often required to use a specified level of “effort” when performing their obligations. But what distinguishes “best efforts,” “commercially reasonable efforts” or “good faith...more
CVS to Pay $37.8 Million to Settle Overbilling Claims - CVS Pharmacy, Inc. agreed to pay $37.8 million to settle several lawsuits in which the United States intervened that alleged that CVS over-dispensed and overbilled...more
Colorado’s Family and Medical Leave Insurance (FAMLI) program has provided employees with paid leave for major life events since 2024, including bonding with a new child and caring for a family member with a serious health...more
While we U.S. Supreme Court practitioners and observers await decisions in several already-argued cases of great significance regarding the separation of powers and executive authority, the Court this morning issued a per...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) Provider Self-Disclosure Protocol (SDP) provides a well-established and important avenue for all health care entities subject to OIG's CMP...more
Recorded live at the NCLifeSci 2025 Annual Meeting, hosts Heather Matthews and Seth Hudson welcome episode guest Ron Phillips, Senior Vice President of Policy for the Animal Health Institute. Representing companies that...more
The U.S. Food and Drug Administration (FDA) on Dec. 2, 2025, issued its draft guidance on Monoclonal Antibodies: Streamlined Nonclinical Safety Studies Guidance for Industry, the agency's most recent step in reducing animal...more
Clinical trial research, like medicine more generally in the European Union (EU), is regulated by a network of national competent authorities from each of the Member States of the European Economic Area (EEA) working with the...more
The biggest item on the agenda this week is continued discussion of the expiring enhanced advanced premium tax credits (APTCs). As part of the deal to reopen the government last month, Senate Majority Leader Thune (R-SD)...more
On Sunday, December 7, 2025, Congress released the final draft compromise version of the FY 2026 National Defense Authorization Act (NDAA), and the package includes the BIOSECURE Act, reflecting weeks of additional...more
This memorandum directs the Secretary of Health and Human Services and the Director of the Centers for Disease Control and Prevention to review best practices from peer, developed countries for core childhood vaccination...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • Bipartisan AGs Urge Congress to Shut Down Federal AI...more
Colleges and universities throughout New York will now be required to publish their policies on the circumstances under which they will notify parents, guardians or other emergency contacts when a student under 21 has an...more
Key Takeaways - AI-driven oversight will accelerate enforcement. DOJ, HHS-OIG, and CMS are scaling machine learning tools that rapidly flag outlier billing, telehealth spikes, and risk-adjustment irregularities — increasing...more
Bipartisan talks on the soon-to-expire enhanced advanced premium tax credits (APTCs) are ongoing, and the Senate Health, Education, Labor, and Pensions Committee held a hearing on healthcare affordability, but no bipartisan...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
As Sam Cooke famously sang, “It’s been a long, a long time coming.” In the latest sign that the Food and Drug Administration is maintaining its focus on direct-to-consumer (“DTC”) advertising, the Office of Prescription Drug...more