Perspectives on Life Sciences

Arent Fox has been monitoring daily updates from the top scientific journals and similar sources to get the most accurate information as soon as it is first made available. Here is a brief summary of the key issues that are of concern.

The U.S. Food and Drug Administration (FDA) issued a guidance document today outlining its procedures for conducting clinical trials of investigational products in view of the worldwide COVID-19 outbreak.

Arent Fox LLP is pleased to announce the expansion of its Patent practice and Life Sciences group with the addition of Counsels Daniel C. Stelter and Laurence H. Posorske, Ph.D. Mr. Stelter joins the firm’s San Francisco office, while Mr. Posorske joins Arent Fox in Washington, DC.

The First Circuit handed the generic pharmaceutical industry an early Valentine’s Day treat earlier this month by resuscitating an antitrust suit against Sanofi by direct purchasers of insulin glargine.

Last month, Representatives Sean Patrick Maloney (NY-18) and Grace Meng (NY-6) introduced the Natural Cosmetics Act that would define the term “natural” as it relates to personal care products and give the US Food and Drug Administration (FDA) authority to enforce the new requirements. 

IP Partner Pamela M. Deese is a featured speaker at the Brand Protection Summit, co-hosted by CounterFind and Warner Music Group on November 7th, 2019 in New York.

Twenty-five Arent Fox LLP practices have been recognized in the 2020 “Best Law Firms” rankings that are published annually by US News & World Report and Best Lawyers.

Partner Alexander H. Spiegler will present “US Case Law Update” at the CIPA Annual Life Sciences Conference 2019 on November 11, 2019.

On October 18, Arent Fox’s New York office will host a one-of-a-kind event on behalf of the New York State Bar Association that focuses on the intersection of FDA and sports law.

Please join us on October 10 for an engaging lunch program that will address the convergence of medicine and the Internet of Things.

The protection of intellectual property in the biotech industry is critical. Patents are the most common form of IP protection for biotech inventions.

WASHINGTON — Fifty Arent Fox LLP attorneys have been rated as leaders in their profession by The Best Lawyers in America 2020.

Life Sciences Counsel Stan Abramson will speak on a panel at a Farm Foundation Forum about the challenges and opportunities of implementing a new biotechnology regulation review process on July 23, 2019, at the National Press Club.

Life Sciences Partner Karen Ellis Carr will speak at the Farm Foundation® Forum, “Gene Editing: Opportunities and Challenges,” at the National Press Club on July 17, 2018.

Arent Fox LLP is pleased to announce the expansion of its nationally recognized Food, Drug, Medical Device & Cosmetic practice with the addition of Partner Deborah M. Shelton.

On June 6, the US Department of Agriculture (USDA or Agency) released its proposed revision to Part 340, the regulations implementing USDA’s authority over genetically engineered (GE) organisms, including GE plants.

The Action Plan is intended to clarify the agency’s science- and-risk-based approach to regulating such products with the stated goals of fostering innovation, enhancing public communication and outreach, and increasing coordination between FDA and its federal and international counterparts.

Last week, USDA’s Agricultural Marketing Service convened a webinar to accept public comments on implementing the hemp provisions included in the 2018 farm bill.

Arent Fox hosted the Institute of Food Technologies and American Society for Nutrition’s 8th Annual Food Policy Impact meeting at the DC office on February 11-12th.

While he did not use a hemp pen like the one used by Senate Majority Leader Mitch McConnell (R-KY) to sign the conference report, President Trump signed into law the 2018 farm bill that includes a provision that legalizes hemp. Specifically, the provision would remove hemp from the federal list of c

Joel Wallace was quoted on a recent ruling from Federal Judge Reed O’Connor in the Federal District Court in Fort Worth, Texas, that the Affordable Care Act’s (ACA) individual coverage mandate is unconstitutional and, in the absence of the individual mandate, the rest of the ACA cannot stand.

Arent Fox FDA Associate Emily Leongini will present at CBI’s Bio/Pharma Compliance Congress on Non-promotional Activities.

Partner Karen Carr and Associate Emily Leongini will participate as speakers at the 3rd Annual Dietary Supplement Regulatory Strategy Conference in December 2018.

NEW YORK – Earlier this year, Yeshiva University’s Katz Graduate Business School introduced a new 36-credit Master of Science in Biotechnology Management and Entrepreneurship designed to prepare future business leaders in the life sciences to successfully navigate the launching new medical drugs.

Brian Ronholm, Senior Director of Regulatory Policy, and Emily Leongini, Associate, will present at FoodSafety Tech’s 2018 Food Safety Consortium.