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
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
The Supreme Court’s day started with the specter of yet another leak of a reproductive rights decision having occurred....more
COMPETITION - Action brought on 5 February 2024 - Coöperatieve Rabobank Vs. Commission - Case T-57/24 Re: annulment of Commission Decision C(2023) 7811 of 22 November 2023 relating to proceedings under Article 101 TFEU and...more
Last week, the Environmental Protection Agency (EPA) announced new regulations to reduce ethylene oxide emissions. According to the EPA’s press release, the new regulations are “the strongest measures in U.S. history to...more
COMPETITION - Commission clears acquisition of Frigoscandia by Dachser (M.11452) - Midday Express - Commission clears acquisition of Kiinteistö by MassMutual and Mubadala (M.11403) - Midday Express...more
California’s Pharmaceutical and Sharps Waste Stewardship Act requires pharmaceutical companies doing business in the state to develop and submit a “stewardship plan” to CalRecycle, a branch of the state’s Environmental...more
As savvy investigators in Congress and the Biden-Harris Administration prepare for new and expanded government investigations, it is time for potential targets to assess and address their vulnerabilities. Investigators in...more
2020 AG Elections- Utah Attorney General Fends Off Challenger in Republican Primary- •Incumbent Utah AG Sean Reyes won the July 2, 2020 Republican primary for AG over challenger David Leavitt. •AG Reyes will face...more
The U.S. Environmental Protection Agency’s final rule governing management of hazardous waste pharmaceuticals became effective August 21, 2019. The new regulations apply to the management of hazardous waste pharmaceuticals by...more
On May 6, 2019, the Ohio EPA Division of Environmental Response and Revitalization issued an early stakeholder outreach public notice, through which it seeks stakeholder input on Ohio EPA’s intent to incorporate recent...more
• The U.S. Environmental Protection Agency (EPA) has published a new rule to address the handling, storage, transportation and disposal of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors. •...more
Following eight years of Republican majorities in Congress, Democrats took control of the House of Representatives in January 2019, thereby regaining the ability to control committee and subcommittee agendas, hold hearings...more
On December 11, 2018, U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule. The final rule retains a proposed requirement, opposed by industry, that prescription pharmaceuticals sent...more
Barnes Johnson, Director of the United States Environmental Protection Agency (“EPA”) Office of Resource Conservation and Recovery (“RCRA”) authored a September 11th memorandum titled: Management of Household...more
A new rule proposed by the EPA to take effect in July 2018 would redefine pharmaceutical waste under the Resource Conservation and Recovery Act (RCRA), fundamentally altering how the pharmaceutical supply chain currently...more
Medical Monitoring Bill Moves On - The House Judiciary Committee sent a version of S.197 to the Senate floor that eliminates the Senate-passed provisions creating strict, joint and several liability for release of harmful...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
On 28 April 2017, the European Commission (the EC) published a “roadmap” on the strategic approach to pharmaceuticals in the environment, particularly in the aquatic environment. Concurrently, the EC launched a 12-week...more
Treasurer Will Build Public Pension Plan for Small Business - State Treasurer Beth Pearce on Wednesday asked the Senate Economic Development, Housing and General Affairs Committee to create the framework for a...more
The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e-newsletter, which offers a legal and regulatory update covering France and Europe for December 2016. ...more
Several hundred business leaders, engineers, attorneys and academics gathered last week for an annual symposium on 3D Printing hosted by Benesch, Friedlander, Coplan & Aronoff. The ability to form physical objects from...more
The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more
The United States and 11 other Pacific Rim trading partners recently announced that they have come to a provisional agreement on the wide-ranging trade agreement known as the Trans-Pacific Partnership (“TPP”), which, over...more
Federal and state hazardous waste handling and disposal requirements, which were established to address issues related to industrial waste generators and disposal facilities, are often a complicated and awkward fit for retail...more
On June 28, 2013, King Pharmaceuticals LLC (“King”) agreed to pay a $2.2 million fine and take measures to comply with the Clean Air Act (CAA) to resolve alleged failures to comply with major source requirements at its...more