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Insights on Life Sciences

376 total results. Page 5 of 16.

Health Care Counsel Blog
CMS Scraps Most Favored Nation Drug Reimbursement Model
August 10, 2021
Stephanie Trunk

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.

Health Care Counsel Blog
CY 2022 HOPPS Proposed Rule: What Pharmaceutical Manufacturers Need to Know
August 5, 2021
Stephanie Trunk

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. 

Alerts
Can Public and Private Entities Impose COVID-19 Vaccination Requirements? DOJ Weighs In
August 2, 2021
Shoshana Golden, Cissy Jackson

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.

Health Care Counsel Blog
Physician Fee Schedule Proposed Rule for 2022 Released: What Pharmaceutical Manufacturers Need to Know
July 20, 2021
Stephanie Trunk

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.

Alerts
The New and Improved Prop 65? Maybe, Maybe Not
July 15, 2021
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D.

Prop 65 Counsel: What To Know

Health Care Counsel Blog
Supreme Court To Hear Case Impacting Medicare Reimbursement for 340B Drugs
July 8, 2021
Stephanie Trunk

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.

Alerts
Is Delta Taking Over?
June 23, 2021
Robert G. Edwards, Ph.D.

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.

Alerts
Drug Importation Lawsuit Stays Alive, For Now
June 14, 2021
Stephanie Trunk

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.”

Press Release
Arent Fox Secures $1 Million in Attorney’s Fees and Costs For Discovery Abuses on Behalf of Sabinsa Corporation
June 2, 2021

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.

Press Release
Chambers USA Ranks 42 Arent Fox Attorneys, 17 Practices Among Nation’s Best
May 24, 2021

Chambers USA: America’s Leading Lawyers for Business has recognized 42 Arent Fox LLP attorneys as leaders in their field.

Alerts
North Dakota Becomes Latest State to Enact Drug Transparency Law
May 17, 2021
Stephanie Trunk

Similar to the laws of several other states, the North Dakota law contains three main disclosure requirements that apply to “drug manufacturers”

Alerts
Proposed Prop 65 Regulation Would Require Cannabis Products to Warn About Impacts on Child Behavior and Learning
May 17, 2021
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D.

Prop 65 Counsel: What To Know

Alerts
Tax Court Allows Mylan to Deduct Patent Suit Legal Fees
May 17, 2021
Jeannette Carneiro McLaughlin, Justin A. Goldberg

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.

Alerts
New Developments in COVID-19 Vaccine, Testing, and Treatment Review
May 12, 2021
Jeannette Carneiro McLaughlin, Justin A. Goldberg

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.

Events
Biden's First 100 Days: What Does It Mean for Life Sciences Companies?
April 29, 2021
Stephanie Trunk, Byron Dorgan*

Join us for a lively discussion on areas of focus for life sciences companies under the new Biden Administration.

Alerts
Congress Passes New Laws to Further Encourage Use of Generics and Biosimilars
April 16, 2021
Stephanie Trunk

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.

Alerts
Prop 65 Newsletter: Preliminary Injunction Temporarily Blocks Prop 65 Enforcement of Foods Containing Acrylamide
April 15, 2021
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D.

Prop 65 Counsel: What To Know

Events
HDA Traceability Webinar Series: Reaching 2023
April 15, 2021
Brian P. Waldman

Partner Brian Waldman is a featured speaker in this year’s opening webinar of the Healthcare Distribution Alliance’s Traceability Webinar Series.

Alerts
Federal Circuit Affirms PTAB Decisions Holding Computer-Based Diagnostic Method Claims Ineligible
April 14, 2021
Richard J. Berman, Michael Scarpati, Ph.D.

Decision highlights the need for applicants to focus on additional improvements to technology when drafting and prosecuting applications directed to computer-implemented diagnostics methods.

Alerts
Florida Gov. Ron DeSantis Bans COVID-19 Passports
April 9, 2021
Henry Morris, Jr.

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.

Alerts
FDA Announces New Fees for Manufacturers of Over-the-Counter Drugs
April 7, 2021
Emily Cowley Leongini

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.

Health Care Counsel Blog
CMS Open Payments System – Reminder for Reporting Entities
March 23, 2021
Stephanie Trunk

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.

Health Care Counsel Blog
Texas Medicaid Program – Update for Drug Manufacturers
March 23, 2021
Stephanie Trunk

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 Care Counsel Blog
Health Resources and Services Administration Enjoined from Implementing the 340B Dispute Resolution Rule
March 18, 2021
Stephanie Trunk

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.

Alerts
Chemical (Octocrylene) in Sunscreen Products Transforms into Carcinogen
March 15, 2021
Lynn R. Fiorentino, Debra Albin-Riley, Brian P. Waldman, Robert G. Edwards, Ph.D.

Prop 65 Counsel: What To Know

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