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
On August 1, 2024, following five years of litigation, Tevra’s antitrust suit against Bayer Healthcare LLC came to an end. Tevra, a manufacturer of generic version topical flea and tick medications, alleged that Bayer engaged...more
On August 1, 2024, a unanimous jury in the United States District Court for the Northern District of California found plaintiff, a veterinary drug manufacturer, failed to allege a relevant antitrust market under Sherman Act,...more
Federal Circuit Allows Teva Patents to Remain in Orange Book. - The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...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
Pharmaceutical manufacturers are increasingly finding themselves defending decisions to list in the U.S. Food and Drug Administration's (FDA) Orange Book patents that they assert are associated with their products. The...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
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
In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...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
Attempting to put some teeth into the policy statement that it issued last month, the FTC sent letters to 10 pharmaceutical companies, asserting that their listing of over 100 patents in FDA's Orange Book for a variety of...more
A group of 42 AGs settled with Indivior Inc. to resolve allegations that the pharmaceutical company violated the Sherman Act and state antitrust laws by engaging in anticompetitive activities to impede competition from...more
DOJ Files FCA Complaint Against Major Pharmacy Retailer Based on Alleged Violations of Controlled Substances Act - On March 13, 2023, the Department of Justice (DOJ) announced that it filed a complaint in intervention...more
Americans spend on average about $1,300 per person per year on prescription drugs, which represents only about 13.3% of the total paid-for drugs in the US. Private insurers, Medicare, and Medicaid pay another 81.8%. ...more
The Seventh Circuit recently confirmed that Actavis is the appropriate framework to assess biosimilar patent settlements, despite the differences in the regulatory structure—the first appellate court ruling on this issue. In...more
On July 11, 2022, the United States District Court for the District of Kansas approved a $264 million settlement against Mylan and certain of its subsidiaries in the case In Re EpiPen (Epinephrine Injection, USP) Marketing,...more
Since the last edition of the QCC, there has been a series of dramatic developments in the criminal antitrust enforcement space in the U.S. from the Department of Justice’s Antitrust Division (Division)....more
On Wednesday, March 30, 2022, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia, released a redacted opinion dismissing the Federal Trade Commission’s follow-on antitrust suit regarding Endo...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
A bipartisan group of AGs, led by New York AG Letitia James, and the FTC reached a settlement with pharmaceutical company Vyera Pharmaceuticals (formerly known as Turing Pharmaceuticals) and its parent company (collectively...more
In March 2021, our experienced intellectual property, antitrust, and health care litigation lawyers shared some predictions on antitrust policy and enforcement in the health care sector. In “Health Care Antitrust under...more
On July 20, 2021, after nearly four years of litigation, Johnson & Johnson (J&J) and Pfizer have agreed to dismiss all claims asserted in the antitrust suit brought by Pfizer in the Eastern District of Pennsylvania regarding...more
On July 9, 2021, the Biden administration issued an “Executive Order on Promoting Competition in the American Economy” (“EO”) that seeks to “promote the interests of American workers, businesses, and consumers.”1 That same...more
Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: J&J Settles Opioid-Related New York Suit for...more
While too many of us get overdosed with clownish depictions - from doctors, hospitals, insurers, and corporations, especially Big Pharma firms - of how the civil justice system operates, it’s always worth a reminder of the...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