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?
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more
The other shoe has dropped! At least it has in the world of counterfeit pharmaceuticals. Since early in the pandemic, the US has faced a significant and still ongoing wave of counterfeit PPE entering the country from abroad....more
At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective equipment (PPE) as evidence...more
In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more
In the past week, President Biden signed the American Rescue Plan, which provides $10 billion to expand domestic production of medical supplies. The President also announced that all adults in the U.S. will be eligible for...more
2020 obviously will be the Year of the Pandemic. However, when it comes to energy, 2020 will also be known as the Year of the Great Disconnect. Thanks to the COVID-19 Pandemic, never have fossil fuels been more important...more
The Food and Drug Administration (FDA or the Agency) announced on October 7 that it will no longer review Emergency Use Authorizations (EUAs) for laboratory developed tests (LDTs). LDTs are a distinct category of in vitro...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more
To address the increased usage and shortages of surgical masks as a result of combatting COVID-19, on August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for disposable,...more
Gilead Sciences Inc. reports that its remdesivir virus treatment has been positively correlated with a 62% reduction in death risks compared with the standard of care in an initial analysis....more
Recently the United States Patent and Trademark Office (USPTO) announced a new prioritized examination program for trademark and service mark applications meeting certain requirements. The program allows applicants to...more
U.S. health care providers should closely inspect PPE equipment bought from Chinese companies in light of recent revelations regarding the registration practices of approximately 1,300 Chinese entities....more
COVID-19 is transforming the way businesses create products and go-to-market, especially when launching health products during a pandemic, on an expedited timeline. How are they managing the regulatory requirements and public...more
On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more
On May 26, 2020, the U.S. Food and Drug Administration (“FDA” or “Agency”) issued an immediately in effect guidance, Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for...more
In Washington: White House press secretary Kayleigh McEnany on Monday said that President Trump is “open” to another coronavirus stimulus package and that he still wants a payroll tax cut, which many Republicans do not...more
On 3 June 2020, the AFMPS issued the third version of the Agency’s alternative test protocol (ATP) for surgical face masks. The alternative test protocol was initially published on 14 April 2020, and allowed masks that had...more
On 18 May 2020, the European Commission issued a guidance document, regarding the verification of the lawful placing on the EU market of medical devices and personal protective equipment (PPE) in the COVID-19 context. ...more
The COVID-19 pandemic has changed most governments' views on the strategic relevance of the domestic healthcare sectors across the globe. Although the European Commission, and also the German government, have re-emphasized...more
Cui bono? That query in Latin — Who benefits? — affirms for linguists that sketchy practices date to Ancient Rome and earlier. But who knew the phrase would be so applicable for U.S. taxpayers considering dubious aspects of...more
The spread of COVID-19 is causing Europe to experience one of the greatest health crises in decades, the consequences of which are still unpredictable. Faced with this unprecedented situation, the governments of different...more
Efforts to increase testing are occurring at the national and state levels. The Food and Drug Administration (FDA) continues to crack down on firms marketing products – including drugs, testing kits and personal protective...more
Faced with the unprecedented sanitary crisis caused by the COVID-19 epidemic, Article 4 of emergency law n° 2020-290 of 23 March 2020 has created the new legal concept of a health state of emergency and has invoked this...more
ANALYSIS - Product Liability Risks for Medical Devices in the UK - In order to fast-track the development, manufacture and supply of key medical equipment and devices vital in the fight against COVID-19, governments,...more