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 13, the Federal Circuit issued a precedential ruling in Allergan v. MSN Laboratories (Case No. 24-1061). This decision reversed the District of Delaware's application of the Federal Circuit precedent in In re:...more
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more
Top Tidjane Thiam ally Pierre-Olivier Bouee, Credit Suisse’s COO, has resigned in the wake of an internal probe finding that he “ordered the surveillance of the bank’s former wealth-management chief, Iqbal Khan, without...more
On Wednesday, Celltrion announced its completion of its Phase 3 clinical trial for Remsima SC, a subcutaneous version of its biosimilar Remsima® (infliximab). According to Celltrion, “[t]he subcutaneous formulation allows...more
Case Name: Allergan Sales, LLC v. Sandoz. Inc., Nos. 2017-1499, 2017-1500, 2017-1558, 2017-1559, 2017 U.S. App. LEXIS 26312 (Fed. Cir. Dec. 22, 2017) (Circuit Judges Moore, Mayer, and Hughes presiding; Opinion by Hughes, J.)...more
Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s...more
Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast...more
On Thursday, July 13, 2017, FDA’s Oncological Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilars of two blockbuster cancer drugs. The first, Amgen and Allergan’s ABP-215, is a proposed biosimilar...more
Case Name: Allergan Sales, LLC v. Sandoz, Inc., No. 12-cv-207-JRG, 15-cv-347-JRG, 2016 U.S. Dist. LEXIS 135088 (E.D. Tex. Sept. 30, 2016) (Gilstrap, J.) - Drug Product and Patent(s)-in-Suit: Combigan® (brimonidine...more
Case Name: Allergan, Inc., v. Sandoz Inc., Civ. No. 2014-1275, 2015 U.S. App. LEXIS 13616 (Fed. Cir. Aug. 4, 2015) (Circuit Judges Lourie, Linn, and Hughes presiding; Opinion by Lourie, J.) (Appeal from E.D. Tex., Schneider,...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
Allergan, Inc. v. Apotex Inc. - Addressing the issue of showing a reasonable expectation of success when making obviousness combinations in the context of broad genus claims, the U.S. Court of Appeals for the Federal...more