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
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
The United States District Court for the Middle District of North Carolina, applying North Carolina law, ruled that neither a contract exclusion nor a professional services exclusion contained in a D&O policy barred coverage...more
A Social Media prescription from America’s top doctor - Imagine sending your teen-aged kid or grandkid out every day to a full-time job in the tech industry. The hours are flexible, and they say they like it...sort of....more
The United States Court of Appeals for the Seventh Circuit, applying Illinois law, has held that a $100 million settlement between the United States government and a pharmaceutical company for claims arising under the False...more
On February 23, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion 23-02, approving a pharmaceutical company’s program to provide a free 14-day supply of an...more
Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more
2022 was an eventful year on the 340B front, packed with updates to consequential litigation, proposed new rules, ongoing uncertainty into the Health Resources and Services Administration's (HRSA) underlying enforcement...more
In a move akin to last-minute gift-giving, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) released FAQ 56 on December 23, 2022, which provides relief regarding the Prescription Drug...more
Key Points - A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more
Some important insurance decisions were handed down over the past month. We begin in Ohio, where public nuisance claims by state and local governments over opioids and lead paint were on full display. In Acuity, the...more
Since 2021, in an effort to encourage greater transparency in the prescription drug industry, there has been a national trend toward increased state licensing and regulation of Pharmacy Benefit Managers (PBMs). PBMs are...more
This is the sixth installment of our series of articles reviewing some of the key trends and developments currently impacting the U.S. insurance industry. Lead Paint - Coverage issues relating to the $400...more
On March 9, 2022, the U.S. Court of Appeals for the Ninth Circuit, in Sentynl Therapeutics, Inc. v. U.S. Specialty Ins. Co, 2022 WL 706941 (9th Cir. Mar. 9, 2022) (applying California law), affirmed a district court’s holding...more
Cases discussed in our January Insurance Update answer these questions: •A commercial crime policy covers property that the insured “holds for others.” In the context of a phishing scheme, does “hold” mean the insured...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update 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
How Can Mental Health and Substance Use Disorder (SUD) Parity Laws Help Battle the Overdose Epidemic? Learn the Answers—and Catch Up on the Most Recent State and Federal Developments—at a New Webinar from the AMA and Manatt. ...more
Welcome back to the Class Action & MDL Roundup! Our summer edition covers notable class actions from the second quarter of 2020. In this edition, the Judicial Panel on Multidistrict Litigation (JPML) weighed in on several...more
This 11th edition of Unprecedented, our weekly update on COVID-19-related litigation, identifies news reports placing the number of COVID-19 filings at around 2,700, with insurance coverage disputes former the single largest...more
With healthcare playing such a central role in the election, what could the Super Tuesday results mean for healthcare stakeholders? On March 2—the day before Super Tuesday—Manatt Health will explore these questions in a new...more
In Target Corporation v. Golden State Ins. Co. Limited (No. B279995, filed 10/10/19), a California appeals court held that there was no duty to defend or indemnify a retail pharmacy against allegations that it had mislabeled...more
With an overwhelming amount of bi-partisan support, on May 7, 2019, Georgia enacted the Pharmacy Anti-Steering and Transparency Act, O.C.G.A. §26-4-119 (the GA Act). The GA Act goes into effect as of January 1, 2020....more
The Trump Administration has put out its latest prescription to try to slash out-of-control prescription drug prices: Officials want to call medication “rebates” what they say they’ve really become — “kickbacks” — and crack...more
...The opioid crisis gripping the United States is a national tragedy affecting hundreds of thousands of lives, with a significant ripple effect on businesses and public entities. Between 1999 and 2016, opioid overdoses...more