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
Yesterday, the Supreme Court denied certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, locking in the Federal Circuit’s second panel decision (hereafter “GSK v. Teva”), which held that Teva’s attempted...more
Coreg® (carvedilol) - Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more
The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...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
The Third Circuit recently denied a petition for rehearing en banc a panel’s earlier decision in the In re Flonase Antitrust Litigation. In that case, the panel decision addressed the degree to which class settlements can...more
Case Name: GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA, 2017 U.S. Dist. LEXIS 82534 (D. Del. May 23, 2017) (Burke, M.J.)....more
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Civ. No. 14-878-LPS-CJB, 2016 U.S. Dist. LEXIS 94438 (D. Del. July 20, 2016) (Burke, M.J.) - Drug Product and Patent(s)-in-Suit: Coreg® (carvedilol); U.S....more
This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more
The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more
Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...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
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 August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more
Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) - Drug Product and Patent(s)-in-Suit: Coreg®...more
It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more
The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more
Are claims that recite a “solvate” of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates? In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., the Federal Circuit...more