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 Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more
The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more
The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....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
As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more
On May 6, 2025, Indiana Governor Mike Braun signed Indiana HB 1666 into law. This new law grants Indiana’s attorney general authority to investigate market concentration of health care entities, modifies existing requirements...more
Following the election in February, the party leaderships of CDU, CSU and SPD have agreed on a coalition agreement titled “Responsibility for Germany”. The 146-page document also sets out aspects regarding the healthcare and...more
The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...more
No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more
The Georgia House of Representatives achieved the trifecta on Thursday, combining three favorite legislative traditions in one moment on the floor: recognition of a local novelty with an invite resolution, the appearance of a...more
Update: The Government of Canada announced an agreement with the Yukon ($9.5 million over four years). The agreement text is available in the updated National pharmacare bilateral agreements resource....more
On February 27, 2025, the Government of Canada and Manitoba signed the first national pharmacare agreements under Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”), which received royal assent on October...more
The giant firms that track trends for big businesses have glum news for all of us: Health care costs are spiking anew this year. The rise, one consultancy predicts, will be the highest in 13 years....more
Amidst the usual suits and blazers, white dresses and tuxedos have been appearing with increasing frequency around the Georgia State Capitol this spring. Apparently word is out amongst the city’s photographers that the...more
Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...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
On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more
“Manufacturers are responsible for meeting all four parts of the definition of bona fide service fee before a fee can qualify as a bona fide service fee.” ...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more
The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its CEO, Frederick Cooper, to resolve allegations that the company provided unlawful...more
On December 11, 2024, a bill was introduced in the U.S. House of Representatives that, if enacted, would have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country. Titled the...more
The Inflation Reduction Act (IRA), passed in 2022, made changes to the way drugs are covered and reimbursed in Medicare. While some of the changes taking effect this year could save the government money, beneficiaries may...more
The Inflation Reduction Act (IRA) significantly changed the popular Medicare drug programs. While an IRA policy goal is to reduce the out-of-pocket drug spending, beneficiaries may experience higher drug plan premiums and...more
On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more