False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
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 Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
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
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
Massachusetts federal and state courts issued several important product liability decisions in 2023. Nutter’s Product Liability practice group reviewed these cases and report on their significant holdings as follows ...more
Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision. On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more
A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended...more
MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more
From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
NAD Won’t Rename Supplement Maker - Innovix Pharma loses on product claims but gets to keep its calling card. Nerding Out - Aside from the intricacies of advertising, advertising law, and the disputes engendered...more
In August 2018, the Province of British Columbia (Province) commenced a class action on behalf of itself and other provincial and federal governments against approximately 50 pharmaceutical manufacturers, wholesalers, and...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO; S.D.N.Y. Dismisses Ponzi Scheme Action Against HSBC Hong Kong for Lack of Personal Jurisdiction; Delaware Court of Chancery...more
Welcome to 2020's second edition of Product Lines, our e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal issues. As you will...more
On July 13, 2020, the Second Circuit affirmed in part and vacated in part the dismissal of Exchange Act claims against a pharmaceutical company (the “Company”) and certain individual defendants in connection with alleged...more
2019 Filings - In 2019, the number of securities class action cases filed against life sciences companies reached record levels. According to Cornerstone Research, lawsuits against pharmaceutical companies increased by 40...more
On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive...more
Massachusetts state and federal courts issued a number of important product liability decisions in 2019. The Product Liability practice group at Nutter recently reviewed these cases. Highlighted below are some of the key...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more
Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more
In 2019, significant developments are expected on issues that have been percolating in the mass tort and class action litigation arena for several years. The U.S. Supreme Court is expected to rule on cases relating to...more
FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more