Perspectives on Prescription Drugs, Biologics & Diagnostics
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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.
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.
Applicable drug manufacturers and group purchasing organizations that are subject to the reporting rules under the Open Payments System are reminded that March 31, 2021, is the final day to submit and attest to data for the June 2021 publication of Program Year 2020 data.
Texas Health and Human Services announced that beginning April 1, 2021, drug manufacturers who wish for their products to be added to the Texas Drug Code Index (the Texas Medicaid formulary) must create an electronic account.
Immediately at issue was Lilly and Company and Lilly USA’ refusal to sell covered outpatient drugs at the 340B Ceiling Price to contract pharmacies acting as agents for 340B Covered Entities. Several 340B Covered Entities had petition for a hearing by the ADR panel.
The American Rescue Plan Act of 2021, signed into law by President Biden on March 11, 2021, is a $1.9 trillion aid package that provides assistance to businesses and individuals experiencing financial hardship due to COVID-19.
It covers both single-use (disposable) and reusable products for use by workers and by the general public.
FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests.