Perspectives on Prescription Drugs, Biologics & Diagnostics
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Twenty-five Arent Fox LLP practices have been recognized in the 2022 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.
Stephanie Trunk will participate in the American Conference Institute’s Passport to Proficiency on Rx Drug Pricing and Rebate Fundamentals, an intensive virtual training series focusing on essential pricing and rebate concepts under Medicaid, Medicare, and other related government payor programs.
Proposed Rules Seek to Repeal Multiple Trump Era Regulations That Received Prior Industry Scrutiny
The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals” (the PhRMA Code or the Code).
Sixty-nine Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2022.
Hospitals have long used color-coded wristbands as a patient safety initiative. Recently, the FDA issued a letter to medical device manufacturers to caution them against using colors for device identification wristbands that could create confusion for clinicians and result in inappropriate medical
CMS has released a proposed rule (the Proposed Rule) which, if finalized and adopted, would rescind the Trump Administration’s attempt to align reimbursement under Medicare Part B for certain drugs with benchmark pricing obtained from surveys of other countries.
The Centers for Medicare & Medicaid Services (CMS) has issued its annual proposed rule related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (HOPPS) (the Proposed Rule). Comments on the Proposed Rule are due no later than September 17, 2021.
Since no COVID-19 vaccines have been granted regular FDA approval, the United States Department of Justice sought to clarify whether the vaccines’ EUA status prohibits the imposition of such requirements.
The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in the Federal Register on July 23, 2021.
Prop 65 Counsel: What To Know
The United States Supreme Court has agreed to hear a case that has a direct impact on the 340B Drug Discount Program (the 340B Program) and how Medicare will reimburse hospitals for dispensing of 340B covered drugs, as well as other reimbursement issues.
On February 24, 2021, we first reported on the most significant variants of the novel coronavirus then emerging across the globe and here in the United States.
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the goal of safe importation of prescription drugs.”
On May 24, 2021, the US District Court for the District of New Jersey awarded Arent Fox client Sabinsa Corporation a total of $1,004,659.93 in attorney’s fees and costs as a sanction against Prakruti Products.
Chambers USA: America’s Leading Lawyers for Business has recognized 42 Arent Fox LLP attorneys as leaders in their field.
Similar to the laws of several other states, the North Dakota law contains three main disclosure requirements that apply to “drug manufacturers”
The United States Tax Court on April 27, 2021, ruled that Mylan Inc. could deduct the legal fees it incurred in defending itself against patent infringement claims made by other drug manufacturers while pursuing generic pharmaceutical drug applications.
We have seen biopharmaceutical companies around the world working to tackle COVID-19 in vaccine development, treatment development, and diagnostics, including the creation of world-class vaccines in record time, rapid tests for home use, and effective treatments against this novel virus.
Join us for a lively discussion on areas of focus for life sciences companies under the new Biden Administration.
Congress recently passed two bills that are designed to educate patients and prescribers about biosimilars and thereby encourage their use and to close a loophole in existing law that allows certain branded drugs to retain longer market exclusivity.
Partner Brian Waldman is a featured speaker in this year’s opening webinar of the Healthcare Distribution Alliance’s Traceability Webinar Series.