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
A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
The new amendments to the French framework agreement. The implementation of special hospital preparations and the amendment to the framework agreement concluded between the French professional organization of pharmaceutical...more
After steadying during Q2, it appears the overall volume of deals in the healthcare industry declined in Q3 compared with Q2, and year-to-date 2023 is still down from last year. A slumping economy has no doubt played a large...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more
Editor’s Note: In the autumn issue of the Clinical Research as a Care Option (CRAACO) newsletter, an interview with Manatt Health’s Donna O’Brien gives pharma readers insight into how hospitals view trials, some of the...more
Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more
Executive Summary - The inclusion of racial and ethnic groups in clinical trials has been a national priority for decades, but progress toward that end has been limited. When the Covid-19 pandemic threw into stark relief...more
The healthcare M&A market appears to be steadying. Although deal activity through the year appears slightly below the high-water marks for the corresponding period of 2022, deal activity is generally up from the first quarter...more
Come together with key decision-makers, innovators and investors from across the healthcare, life sciences and private equity (PE) industries during the year’s largest healthcare investment symposium....more
Although healthcare M&A activity in Q3 declined slightly from the previous quarter, analysts believe the activity level declined much less than expected given the numerous headwinds—inflation, rising interest rates, labor...more
In celebration of the 50th episode of our Diagnosing Health Care podcast, we’re looking at how the past 50 years of health law will impact health care in the next 50 years. On this episode, Epstein Becker Green attorneys...more
What To Do When The Government Knocks On Your Lab’s Door - The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more
2022 started strong for healthcare transactions with some reports suggesting a record-breaking January. Although deal activity cooled in February and March, transaction pipelines still indicate that 2022 is on pace to match...more
Drug Pricing Initiatives: Discussion continues regarding pathways to Senate passage of H.R. 5376 (the Build Back Better Act, or BBBA). Potential approaches include a reduced or modified version of the BBBA, although details...more
As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more
Following a record-breaking first quarter, merger and acquisition (M&A) activity within the healthcare industry kept pace during the second quarter of 2021, showing no signs of slowing. Although the volume of deal activity...more
On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more
Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more
From Pricing to Compliance to Coordinated Care, a Wide Range of Critical Areas Saw Regulatory Changes in 2020 That Will Impact the Health Care and Life Sciences Industries in 2021—and Beyond. Find Out How Your Organization...more
The healthcare and life sciences (HCLS) sector remained particularly active throughout 2020. Despite the COVID-19 pandemic, deal activity was very strong in the first half of the year — with notable transactions including...more
In Washington: House Democrats on Monday introduced an article of impeachment against President Trump, charging him with inciting a mob of his supporters to carry out last week’s violent attack on the Capitol. Majority Leader...more
In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more
You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...more