Perspectives on Prescription Drugs, Biologics & Diagnostics
267 total results. Page 1 of 11.
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).
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.
Physician Fee Schedule Proposed Rule for 2022 Released: What Pharmaceutical Manufacturers Need to Know
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.
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.
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.”
Arent Fox Secures $1 Million in Attorney’s Fees and Costs For Discovery Abuses on Behalf of Sabinsa Corporation
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.
Decision highlights the need for applicants to focus on additional improvements to technology when drafting and prosecuting applications directed to computer-implemented diagnostics methods.
With COVID-19 vaccinations increasing, interest has grown in developing COVID-19 passports, digitized verification that the bearer has been fully inoculated against the virus. Last week, however, Florida Governor Ron DeSantis issued an Executive Order banning them in his state.
As we explained in a previous alert, one of the lesser-known provisions of the March 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act was a significant overhaul of the way that most OTC drugs are regulated in the United States.