Perspectives on Prescription Drugs, Biologics & Diagnostics
249 total results. Page 1 of 10.
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.
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.
Health Resources and Services Administration Enjoined from Implementing the 340B Dispute Resolution Rule
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.
Passage of American Rescue Plan Act of 2021 Could Mean Larger Medicaid Drug Rebate Program Rebates for Pharmaceutical Manufacturers
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.
President Biden Orders 100-Day Review of America’s Supply Chains for Semiconductors, Batteries, Critical Minerals and APIs
Marwa M. Hassoun*, David R. Hamill, David R. Hanke, Robert J. Ernest, Natan P.L. Tubman, Jessica DiPietro, John A. Gurtunca, Birgit Matthiesen, Kay C. Georgi
Changes are afoot for key industry sectors with complicated global supply chains.
The novel coronavirus undergoes a mutation about once every 2 weeks, or half the rate seen in influenza.
Mark A. Bloom, Lynn R. Fiorentino, David R. Hamill, David R. Hanke, Marwa M. Hassoun*, David P. Grosso, Elliott M. Kroll, J.H. Jennifer Lee, M. Scott Peeler, Andrew Ross, Julius A. Rousseau, III, D. Jacques Smith, Randall A. Brater, Henry Morris, Jr., Angela M. Santos, Stephanie Trunk
Arent Fox is monitoring policy changes by the Biden Administration to provide timely analysis on how they could impact your business.
With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway.
Recent legislative developments include amendments to expand upon Orange Book and Purple Book listing requirements.
On December 28, 2020, Judge Vince Chhabria of the US District Court for the Northern District of California joined Judge Catherine Blake of the US District Court of the District of Maryland in enjoining the application of the Medicare Part B Most Favored Nations Reimbursement Rule.
Premarket Testing of Diagnostic Medical Software Protected From Claims of Patent Infringement by § 271 Safe Harbor Defense
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-CV-06593 (N.D. Cal. Oct. 16, 2020).