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 "European Antitrust Bimonthly Bulletin” breaks down the major antitrust developments in Europe during the past two months into concise and actionable takeaways. ...more
On July 22, 2024, the European Commission (EC) accepted commitments proposed by Vifor Pharmaceuticals to address disparagement concerns under Article 102 TFEU. This is the EC’s first pure disparagement case and its second...more
The UK CMA has published practical guidance confirming its commitment to ensuring that competition law does not hinder collaborations between medicine manufacturers which aim to make innovative and life-saving combination...more
The UK Competition and Markets Authority (CMA) has taken the unusual step of issuing a prioritisation statement on cooperation between competitors to make combination therapies available to the NHS. The CMA worked closely...more
APRIL – JUNE 2022: KEY THEMES AND TAKEAWAYS - UNITED STATES - • An Overview of Agency Merger Challenges from January 2021 through June 2022 Parties continue to be cautious in litigating challenged transactions. Since...more
The last week has seen crucial developments at the European Commission (EC) and U.S. Federal Trade Commission (FTC) regarding the antitrust review of the $7.1 billion proposed acquisition by Illumina (the leading supplier of...more
On Tuesday, May 11, 2021, an international coalition of competition enforcement agencies including the Federal Trade Commission, the U.S. Department of Justice’s Antitrust Division, Offices of State Attorneys General,...more
This newsletter is a summary of the antitrust developments we think are most interesting to your business....more
On March 16, 2021, the Federal Trade Commission (“FTC”) announced its plans to initiate an international working group that will “identify concrete and actionable steps to review and update the analysis of pharmaceutical...more
Throughout the first half of 2020, much of the world has grappled with the reality of the coronavirus (COVID-19) pandemic, as the outbreak spread rapidly across entire countries and shut down large segments of the global...more
On March 10, 2020, the England and Wales Court of Appeal (CoA) handed down its judgment in the appeals by the U.K. Competition and Markets Authority (CMA) and Flynn Pharma Ltd. against a June 2018 Competition Appeal...more
ANTITRUST AND COMPETITION - The Court Of Justice Of The EU Rules Provides Clarity On The Assessment Of Pay-For-Delay Agreements - The Court of Justice of the EU (CJEU) has backed the UK Competition and Markets Authority...more
On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more
On 14 March 2019, the UK Competition and Markets Authority (CMA) decided to close its investigation into a discount scheme by Merck Sharp & Dohme Limited (MSD). The CMA concluded that there were no grounds for it to take...more
Read the latest news on antitrust, competition, and economic regulation in this summer edition of our quarterly ACER newsletter. ...more
The UK's Competition Appeal Tribunal (the "CAT") has overturned a finding of abuse of dominance against Pfizer Inc. and Flynn Pharma Ltd. The ruling followed appeals by those companies against a 2016 Competition & Markets...more
On 12th July 2018 Competition and Markets Authority (CMA) announced it was extending its timetable in relation to a number of its ongoing investigations involving anti-competitive practices in the pharmaceutical sector. ...more
On 28 June 2018, the UK Competition and Markets Authority (CMA) announced that it has applied to the Competition Appeal Tribunal (CAT) for permission to appeal against the CAT’s judgment on appeals by Pfizer and Flynn against...more
On 7 June 2017, the Competition Appeal Tribunal (“CAT”) set aside parts of the Competition & Market Authority’s (“CMA”) decision in relation to the CMA’s finding that Pfizer and Flynn charged excessive and unfair prices for...more
How to thrive amid uncertainty? This was the question we explored at the 35th FT Global Pharmaceutical and Biotechnology Conference. Here are five key industry trends and corresponding practical legal tips to help companies...more
The UK Competition and Markets Authority (“CMA”) recently published its infringement decision of 7 December 2016 that imposed a fine on Pfizer and Flynn Pharma (“Flynn”) for abusing their respective dominant positions by...more
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more
The Competition and Markets Authority (CMA) in the United Kingdom announced a provisional decision finding that Merck Sharp & Dohme (MSD) violated competition law with its discount pricing on Remicade. This provisional...more
EU Regulators Open Pharma Pricing Investigations Focusing on Abuse of Dominance - The European Commission and UK Competition and Markets Authority (CMA) have both opened new investigations into alleged abuses of...more
The Competition Appeal Tribunal (the “CAT”) in the UK heard on 17 January 2017 an application by Flynn Pharma Ltd and Flynn Pharma (Holdings) Ltd (together “Flynn”) to suspend the Competition and Markets Authority’s (the...more