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?
In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S....more
We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute’s 12th Annual Summit for Women Leaders in Life Sciences Law. This conference is a highlight for us every...more
On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more
The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging...more
While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more
The new ministerial guidance letter (‘LOM’) intended to guide the Economic Committee for Health Products (‘CEPS’) on the pricing strategy for pharmaceutical products and medical devices has been signed and published on 5 May...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more
News Briefs - Nationwide Hospitals Warned of Potential Terror Threat - The American Hospital Association and the nonprofit Health-ISAC (Information Sharing and Analysis Center) are warning of a potential terrorist threat...more
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more