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?
The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
The German Federal Court of Justice (Bundesgerichtshof), tasked with resolving a conflict between two competing pharmacists, sought guidance from the Court of Justice of the European Union ("CJEU") on interpreting the General...more
As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more
Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more
Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more
The Federal Trade Commission (FTC) didn’t mince words. On September 2021, it called out the health app industry for failing to understand the agency’s Health Breach Notification Rule (HBNR) and for not disclosing its...more
Yes. While only one of the pharmaceutical companies within the Fortune 500 states that they sell personal information, the company that has disclosed the sale of information is posting a “Do Not Sell My Personal...more
Most have, but some have not. While the majority of pharmaceutical companies within the Fortune 500 affirmatively state that they do not sell personal information, a significant minority have been silent, or unclear, about...more
Blockchain Initiatives in Healthcare and Other Industries Target Data Integrity, Speed and Analytics - Last week, a not-for-profit alliance of life sciences industries firms announced an expansion of its blockchain project...more
Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical...more
Blockchain—the tamper-proof electronic ledger network technology—first made headlines with the rise of cryptocurrencies like Bitcoin. Independent of that boom-and-bust cycle, the life sciences industry is now exploring ways...more
In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24,...more
Making individual patient-level data available for other research presents companies with challenges, but researchers and companies can take steps to minimize the risks. Originally published in Drug and Medical Device,...more
The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is...more
In a highly anticipated and scrutinized decision, the Centers for Medicare & Medicaid Services (CMS) released a new public data set on April 30, 2015, that includes detailed data regarding the prescribing patterns of...more
Last week, diagnostics services provider Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, announced the launch of BRCA Share, a new datashare initiative that will provide...more
On January 12, 23andMe announced an agreement with Pfizer to provide the drug company with access to anonymous, aggregated information from consumers who bought 23andMe’s test over the past seven years to learn about their...more