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 Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...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
The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more
On May 9, 2024, the U.S. Department of Justice’s Antitrust Division (DOJ) announced it is “upping [its] game” on health care enforcement through the Task Force on Health Care Monopolies and Collusion (HCMC). The most recent...more
On May 15, 2024, the Federal Trade Commission Chair Lina M. Khan appeared before the House Appropriations Subcommittee on Financial Services and General Government to discuss the agency’s FY 2025 budget request and ongoing...more
IN THIS FEBRUARY 2024 ISSUE - UNITED STATES - New Merger Guidelines Released - The US Federal Trade Commission (FTC) and US Department of Justice Antitrust Division (DOJ) issued their updated Merger Guidelines on...more
The European Commission (EC) has published its latest report on competition enforcement in medicines and medical products. Key takeaways are that: EU and Member State authorities imposed multiple material antitrust...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
Amidst a wave of challenges to mergers on novel theories of harm, proposals to revamp both the HSR Filing rules and the Merger Guidelines used for assessing the competitive impact of mergers, and taking steps to enlarge the...more
On December 7, 2023, the Biden-Harris administration announced new initiatives it believes will “lower health care and prescription drug costs by promoting competition.”...more
It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more
In a recent speech, a senior official at the U.S. Department of Justice Antitrust Division noted that “in U.S. antitrust enforcement and competition policy, there is no more important question than what can we do to safeguard...more
In the latest attempt to promote generic drug competition and reduce drug prices, and consistent with broader efforts to enforce the antitrust laws more aggressively, the Federal Trade Commission (FTC) announced on November...more
Assistant Attorney General Jonathan Kanter, for the Department of Justice’s (DOJ) Antitrust Division, has been openly and repeatedly skeptical of merger remedies and settlements: “Merger remedies short of blocking a...more
For years, the antitrust enforcement agencies have indicated their antipathy toward resolving competition issues in proposed mergers by entering into consent decrees that prohibit certain conduct, rather than stopping the...more
The Antitrust Division has been active – like any aggressive prosecution strategy, however, its results have been mixed. Its record in criminal cases has taken serious hits – a stunning set of losses in the chicken...more
The Federal Trade Commission, in coordination with the U.S. Department of Justice Antitrust Division, recently released a summary of the Agencies’ June 2022 joint workshop titled “The Future of Pharmaceuticals: Examining the...more
On May 17, 2023, the Federal Trade Commission (FTC) challenged Amgen Inc.’s (Amgen) proposed acquisition of Horizon Therapeutics plc (Horizon). The complaint is significant in three respects....more
This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more
Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more
Join the Hogan Lovells Antitrust and Competition team on Wednesday, 30 November 2022 where we will look back at the major competition-related events of 2022 and what we can expect next year, including: 1. Major FTC and DOJ...more
The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays....more
In early June, the Federal Trade Commission (FTC) exercised its authority under Section 6(b) of the Federal Trade Commission Act and launched an inquiry into prescription benefit managers (PBMs)....more
On June 3, 2022, Andrew Forman, Deputy Assistant Attorney General of the United States Department of Justice Antitrust Division (DOJ) publicly stated that the DOJ is considering “enhancing antitrust enforcement around a...more
Since the last edition of the QCC, there has been a series of dramatic developments in the criminal antitrust enforcement space in the U.S. from the Department of Justice’s Antitrust Division (Division)....more