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 healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification. The United Arab Emirates (UAE) and Kingdom of Saudi Arabia (KSA) are...more
As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more
The possibility for pharmaceutical companies to usefully resort to investment arbitration has been until recently shrouded in ambiguity. While the possibility to assume jurisdiction over cases concerning the registration of a...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
This newsletter is a summary of the antitrust developments we think are most interesting to your business....more
Transactions in the U.S. healthcare space rebounded in autumn, although with a greater proportion of smaller deals than in recent years. ...more
The UK has announced a bill proposing a new system to screen transactions for national security risk, separate from the system of merger review operated by the Competition and Markets Authority. The National Security and...more
The Justice Department on Wednesday announced an $8.3 billion settlement with Purdue Pharma as part of a deal in which the company will plead guilty to criminal charges “related to its marketing of the addictive painkiller”...more
On 15 April 2020, the Cabinet of the Kingdom of Saudi Arabia (“Saudi Arabia”) issued a resolution approving the Pharmaceutical and Herbal Establishments and Substances Regulation (the New Pharmaceutical Law), providing a...more
The COVID-19 pandemic has changed most governments' views on the strategic relevance of the domestic healthcare sectors across the globe. Although the European Commission, and also the German government, have re-emphasized...more
Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more
As companies and investors navigate the COVID-19 pandemic, they will grapple both with operational disruptions and shifting legal and regulatory environments. On the latter fronts, there is some good news for those involved...more
Almost a decade into the current bull market, many economic prognosticators are warning of a coming downturn. At the same time, political upheaval and uncertainty around the world is changing the landscape for cross-border...more
McDermott Will & Emery is delighted to welcome you to a panel discussion on “Private Equity in Healthcare” and a social reception held in conjunction with the SuperReturn International Conference 2020. Our speakers will...more
As the rest of the world backed away from the deal table, confident US corporates continued buying businesses—especially in the life sciences and TMT sectors, and particularly in the domestic market. US dealmakers had a...more
Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more
MWE China Law Offices and its strategic alliance partner McDermott Will & Emery are proud to co-host our annual Shanghai Life Sciences Forum in partnership with the Redefining Early Stage Investments (RESI) conference. This...more
Credit bureau Equifax is closing in on an agreement with federal and state authorities in which it would pay $650-700 million to resolve claims related to the massive breach it revealed in September 2017 that exposed personal...more
CARTELS & RESTRICTIVE AGREEMENTS - CJEU’S EYE-OPENING RULING ON ANTITRUST COMPLIANCE AND OFF-LABEL MISINFORMATION – C 179/16, HOFFMAN-LA ROCHE AND OTHERS V AGCM, 23 JANUARY 2018 – On 23 January 2018, the CJEU...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter. ...more
The latest round of big bank stress tests are in, and the Fed has rejected the capital plan of Deutsche Bank and limited the payouts of Goldman Sachs and Morgan Stanley....more
In this road map, members of our European Life Sciences Transactions Team provide country-specific perspective and guidance to help you navigate the jurisdictional challenges and differences that you may run into when...more
On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more
U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more