PODCAST: Williams Mullen's Trending Now: An IP Podcast - Who Owns AI Innovation? IP in the Age of Artificial Intelligence
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 242: Business Planning in Healthcare & Life Sciences with Jennifer McEwen of Maynard Nexsen
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 241: Fighting Nurse Burnout with Data-Driven Innovation with Dr. Ecoee Rooney of Indicator Sciences
Unexpected Paths to IP Law with Dan Young and Colin White
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 237: Tackling Cancer with Cellular Immunotherapy with Dr. Leonardo Ferreira of Torpedo Bio
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
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
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 232: Commercial Real Estate for Life Sciences Companies with Vinnie Durand of Savills
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
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 229: Public Health in South Carolina with Dr. Edward Simmer of SC Dept of Public Health
On August 6, 2025, the Federal Trade Commission (“FTC”) filed a motion for preliminary injunction to block Edwards Lifesciences Corporation’s (“Edwards”) $945 million proposed acquisition of JenaValve Technology, Inc....more
Functional foods designed to promote relaxation, better sleep, and improved mood have exploded in popularity, and chocolate is increasingly the delivery method of choice. Calming confections featuring ingredients like...more
On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...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
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
As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024....more
2024 was eventful in the life sciences space – and key trends are expected to continue in the new year. ...more
On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more
U.S. antitrust enforcers launched a flurry of initiatives in the first half of 2024 to identify and prevent antitrust and other violations in life sciences and health care. Among these are two cross-agency Requests for...more
Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more
Explore the unique considerations for mergers and acquisitions in the AI sector, the return of IPOs, the implications of new Supreme Court decisions and other developments in this edition of Skadden’s quarterly Insights....more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
Policy differences are endemic in politics, and the phrase "causing more heat than light" regarding federal drug policy comes readily to mind listening to the rhetoric coming from the Federal Trade Commission in this regard. ...more
Over the last eight months, the US Federal Trade Commission (FTC) has focused on what it characterizes as “improper” Orange Book listings and the impacts of such listings on generic entry....more
The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the...more
On April 30, 2024, the US Federal Trade Commission (“FTC”) announced that it had sent “warning letters” to 10 branded pharmaceutical manufacturers, alleging that the companies had made “improper or inaccurate listing of...more
Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more