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
Last month, the Federal Trade Commission (FTC) and U.S. Department of Justice (DOJ) jointly hosted a public meeting of the interagency “Strike Force on Unfair and Illegal Business Practices.” The meeting was a continuation of...more
Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fourth episode of When Your Life Sciences Are on the Line, where leading...more
The "European Antitrust Bimonthly Bulletin” breaks down the major antitrust developments in Europe during the past two months into concise and actionable takeaways. ...more
News Briefs - Physicians Responsible for Meeting CMS Information Blocking Rules - The Centers for Medicare & Medicaid Services and Office of the National Coordinator for Health Information Technology issued a final rule that...more
Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more
I may be jumping the gun here, but I’m anxious to understand how the new flurry of AI medical devices is performing in the marketplace, or more specifically, whether the devices are failing to perform in a way that...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
In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more
At the mid-year point, 2024 is shaping up to be an eventful year in cartel enforcement. In the United States, the U.S. Department of Justice (DOJ)’s Antitrust Division (Division) enjoyed two significant victories and finally...more
During this session, the panelists discussed medical communications and market access with a particular focus on commercialization. The discussion focused on how firms are leveraging technology and AI to build brands, drive...more
During this session, the panelists discussed the current market outlook for CROs and the key differentiators making them attractive to private equity investors, such as therapeutic area (TA) specialization, their ability to...more
During this session, McDermott Partner Kristian Werling and Jeff Smith, a senior partner at McKinsey & Company, shared insights across the pharma and MedTech services industries, including key trends and opportunities shaping...more
Senate HELP Committee Holds Hearing on Medical Debt. The hearing examined the negative impacts of medical debt and explored potential solutions to address the growing issue. Senators and witnesses highlighted the disparity...more
GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more
Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more
Welcome to our second issue of The Health Record - our healthcare law insights e-newsletter! SCOTUS Agrees to Review Medicare DSH Payments Case - “The suit, Advocate Christ Medical Center v. Becerra, was originally filed in...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more
Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA. ...more
AI is vaulting drug discovery forward leaps and bounds—and now regulators are beginning to catch up, with the United States Patent and Trademark Office recently issuing new guidelines on the patentability of AI-assisted...more
The German federal and state data protection authorities published guidelines for the implementation and use of AI in compliance with the European Union's regulation of personal data ("Guidelines")....more
This update is part of our EU AI Act Essentials Series. The European AI Act is a landmark piece of legislation that establishes the first major comprehensive framework for regulating the use of artificial intelligence,...more
News Briefs - Lawmakers Mull Lifting Restrictions on Physician-Owned Hospitals - Nearly 15 years ago, the construction of doctor-owned hospitals largely ground to a halt. But federal lawmakers now are considering bills that...more