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?
Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more
ACI's virtual 6th Annual Passport to Proficiency on Rx Drug Pricing & Rebate Fundamentals will help you master the fundamentals, comprehend the consequences of new developments, and prepare for the complexities and nuances of...more
President Donald Trump confirmed this week that his administration is actively reviewing the possibility of reclassifying marijuana as a less dangerous drug. This move would follow through on a proposal made under the Biden...more
Earlier this month, the Office of Information and Regulatory Affairs (OIRA) updated its list of rules pending review under Executive Order 12866 to include FDA's request to rescind its controversial Laboratory Develop Test...more
Two leading consulting and expert firms – Cornerstone Research and NERA – recently issued their midyear reports on securities class actions. Both reports noted that the number of filings in H1 2025 remained steady, but...more
Secure your place today for ACI's Inaugural West Coast Summit for Women Leaders in Life Sciences Law. Join industry leaders from pharmaceuticals, biotech and MedTech for an immersive two-day event that explores practical...more
On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include treatment of cytokine release syndrome (CRS) in...more
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2025, including the results of the US Department of Justice’s (DOJ) 2025 National Health Care Fraud Takedown, DOJ...more
Life sciences capital markets in 2025 have been a mixed bag—some rays of light peeking through, but still, plenty of clouds for early-stage companies hoping to tap the public markets. After a long IPO drought, 2024 brought a...more
Under the current administration, there have been significant shakeups at the antitrust enforcement agencies, including the FTC and the DOJ Antitrust Division, which have led to uncertainty regarding enforcement priorities....more
Many publicly traded companies in the life sciences industry are involved in the development of new drugs, devices, diagnostics, and medicines. These drugs and other life science products are subject to the FDA regulatory...more
The International Trade Commission recently issued an opinion in a trade secret-based investigation, Certain Selective Thyroid Hormone Receptor-Beta Agonists, Processes for Manufacturing or Relating to Same, and Products...more
On August 21, the White House and the European Union released a joint statement that sheds some light on aspects of the framework trade deal announced last month. The joint statement confirms the baseline 15% U.S. tariff on...more
Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more
As the page turned on 2025, optimism was high among life sciences dealmakers. Elections in the U.S. and other major economies had concluded, interest rates were poised to come in to focus, and the regulatory environment...more
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
As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more
On August 20, 2025, the United States Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative class action asserting claims under the Securities Exchange Act of 1934 against a pharmaceutical company and...more
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
We have seen plainly what happens when disasters interrupt domestic healthcare supply chains: from N-95 masks to saline, our healthcare system has struggled in the face of hurricanes and a pandemic, as just two recent...more
On June 26, 2025, the Swiss Federal Administrative Court (“Court”) issued its decision in case B-2532/2024, resolving a high-profile dispute over whether an artificial intelligence (“AI”) system can be named as an inventor...more
On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant...more
On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more
On August 18, 2025, Accord BioPharma, Inc. (“Accord BioPharma”) announced the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab) in the United States. ...more
On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more