Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
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
I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more
On 21 July 2022, the Third Circuit in Perrigo Co. v. AbbVie Inc. affirmed the district court’s judgment that the mutual release in the settlement agreement between the parties from an earlier patent infringement and...more
After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more
In a holding that could significantly broaden the antitrust inquiry in the context of the Hatch-Waxman regulatory scheme, on February 13, 2020, the U.S. Court of Appeals for the First Circuit issued an opinion that may have...more
Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...more
On August 28, 2017, in King Drug Company of Florence, Inc., et al. v. Cephalon, Inc., et al., the Eastern District of Pennsylvania denied class certification for direct purchasers asserting Hatch-Waxman reverse-payment...more
The Third Circuit recently affirmed the grant of summary judgment to GlaxoSmithKline (“GSK”) in the nearly 10-year-old Wellbutrin XL Antitrust Litigation, which challenged the lawfulness of settlement agreements resolving...more
Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more
The FTC has recently weighed in again on the evolving interpretation of the Supreme Court’s 2013 opinion in FTC v. Actavis, 133 S. Ct. 2223 (2013). The agency submitted an amicus brief to the Third Circuit in the appeal of...more
Recently, the First Circuit became the second federal appellate court interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc. to hold that non-cash "reverse payments" between pioneer and generic...more
In January, the Federal Trade Commission issued a report on the terms of settlement agreements between branded and generic drug companies in ANDA litigation under the Hatch-Waxman Act, according to the provisions of the...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
On June 17, 2015, the U.S. District Court for the Eastern District of Pennsylvania approved a consent order (the “Consent Order”) between the Federal Trade Commission and defendants Cephalon, Inc. and its parent, Teva...more
A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. “Product hopping” refers to the practice of changing the form or...more
Last week, in In re Cipro Cases I & II, Case No. S198616, the Supreme Court of California adopted the United States Supreme Court's application of the Rule of Reason to the antitrust analysis of so-called "reverse payment"...more
Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more
On June 17, 2013, the U.S. Supreme Court handed down a decision that addressed a “reverse payment” settlement agreement between a brand-name pharmaceutical company (plaintiff patent holder) and multiple generic drug companies...more
Earlier this week in FTC v. Actavis, No. 12-416 (U.S. Jun. 17, 2013), the Supreme Court handed down its long-anticipated ruling on “reverse payment” or “pay-for-delay” agreements, holding that these agreements—while not...more
Today, the U.S. Supreme Court held in Federal Trade Commission v. Actavis, Inc. that so-called “reverse payment” settlement agreements should be analyzed under a rule-of-reason analysis under which the court assesses any...more