Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
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 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
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
Key Takeaways - The Federal Trade Commission (FTC), now under Republican leadership, has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive...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
Illinois Attorney General (AG) Kwame Raoul and Minnesota AG Keith Ellison have joined the Federal Trade Commission (FTC) in a lawsuit to block the acquisition of Surmodics Inc. by GTCR BC Holdings LLC, two major manufacturers...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
Earlier this year we reported on the Federal Trade Commission’s efforts taken against certain drug manufacturers when listing device patents in the FDA’s Orange Book. We concluded that the efforts to date by the FTC had a...more
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more
In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products...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 September 23, 2023, the FTC issued a policy statement advising it would be putting market participants on notice that it intends to scrutinize improper Orange Book listings to determine whether such actions constitute...more
In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade...more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more
News Briefs - Senate Committee Advances Bill on 'Ghost Providers,' PBMs - In a unanimous 26-0 vote, the Senate Finance Committee passed a comprehensive draft package that puts pharmacy benefit manager reform and mental health...more
On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more
Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class action complaint in the Central District of California on August 30, 2023, by users of Medtronic’s InPen® system. The lawsuit alleges...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a roundup of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
As we predicted in the previous edition of this report, 2021 turned out to be a very strong year indeed for US life sciences dealmaking, marked by high transaction values and volumes as the industry continued on its...more
On May 13, 2022, Medtronic, Inc. announced that it completed the acquisition of Intersect ENT, Inc. The transaction was only able to gain approval of the Federal Trade Commission (FTC) upon the agreement that Medtronic sell...more
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more