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
As we previously reported, Sanofi-Aventis sued Merck Sharp & Dohme in the District of Delaware for patent infringement based on Merck’s proposed follow-on biologics of Sanofi-Aventis’s Lantus® and Lantus® SoloSTAR® ([rDNA...more
The UK government’s draft EU Withdrawal Bill (the “Brexit Bill“) aims to incorporate EU directives and regulations into UK domestic law in their current form immediately following Brexit (“Retained EU Law“). This article...more
On May 30th, the Supreme Court ruled in Impression Products, Inc. v. Lexmark International, Inc. that all patent rights are automatically exhausted upon the sale of a product irrespective of contract stipulations and...more
Last May, the U.S. Supreme Court issued a highly-anticipated decision in Impression Products, Inc. v. Lexmark Int’l, Inc., reversing the Federal Circuit and holding that, when a patent holder sells a product, it exhausts all...more
SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision - In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that...more
In Lexmark International, Inc., v. Impression Products, Inc., the en banc Federal Circuit upheld a patent holder’s rights against exhaustion under two circumstances: (1) where the patent holder had sold a patented article...more
Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more