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
The U.S. Department of Health and Human Services (HHS) issued four major rules on Nov. 20, 2020, which was the final day for the Trump Administration to issue a rule with a 60-day implementation period for it to take effect...more
The French anti-gift legal framework was substantially amended by the Ordinance No. 2017-49 dated January 19, 2017. However, these new rules were subject to the adoption of an implementing decree. Their implementation, which...more
UPDATE: On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On September 21, 2020, the Attorney General of Canada cross-appealed. As...more
This article was last updated on July 10, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more
This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more
On December 10, 2019, the parties to the Canada-United States-Mexico Agreement (commonly referred to as USMCA, or the new NAFTA) signed amendments (see summary of revised outcomes) to the Agreement. The original USMCA was...more
The amendments to the Patented Medicines Regulations (Regulations) published on August 21, 2019 have been the subject of two court challenges launched by groups of innovative pharmaceutical companies (22 companies in total)...more
The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more
In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more
As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to...more