Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Heath care fraud remains a top priority for the DOJ. This year’s National Health Care Fraud Takedown was the biggest in United States history, resulting in the prosecution of 324 defendants in connection with over $14.6...more
Novo Nordisk, the manufacturer of Ozempic and Wegovy, has petitioned the Food and Drug Administration (FDA) to add semaglutide, the active ingredient in Wegovy and Ozempic, to the "Demonstrable Difficulties for Compounding"...more
On November 19, 2024, the Massachusetts Board of Registration in Pharmacy (the “Board”) published several memoranda that described the impending non-resident pharmacy licensure requirements and the anticipated timeline for...more
Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more
Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more
Learning Objectives - Describe the basic structure of a 340B program implementation at a hospital or grant-funded clinic - Illustrate the permissible and impermissible uses of 340B-priced drugs - Explain the roles of...more
Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one...more
Whoever authored this new legislation (Chapter 2021-135, Laws of Florida) deserves a pat on the back for an idea whose time has come. When an applicant files for a change of ownership (“CHOW”) or change of location for one of...more
The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more
FDA authority to crack down on illegally marketed stem cell treatments confirmed - On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more
Against the backdrop of an unprecedented opioid epidemic claiming the lives of an estimated 130 Americans each day, Congress passed the federal Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for...more
This is the final episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor under the 340B Program, including by providing technical...more
The U.S. Department of Health and Human Services (“HHS”) recently published a final rule on the 340B Drug Pricing Program (“340B Program”), moving the effective date for changes to the program up to January 1, 2019. Making...more
The State of Ohio Board of Pharmacy recently issued a number of proposed rule sets for public comment. Notably included were new rules on the operation of office-based opioid treatment (OBOT) clinics and rules governing the...more
On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more