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Insights on Life Sciences

344 total results. Page 9 of 14.

News
Aly Featured on Hatch-Waxman Influence on BPCIA Litigation
May 16, 2018
Imron T. Aly

Hatch-Waxman and Biosimilars Practice Group Leader Imron Aly examines how current Hatch-Waxman legal proceedings can be applied to Biologics Price Competition and Innovation Act (BPCIA) litigation.

Events
Food and Drug Law Institute (FDLI) Annual Conference
May 3, 2018
Emily Cowley Leongini

Arent Fox Associate Emily Leongini will speak at the Food and Drug Law Institute (FDLI) Annual Conference hosted May 3-4, 2018 in Washington, DC.

Press Release
Arent Fox Launches Blockchain Group
April 24, 2018

Arent Fox is pleased to announce the launch of a new Blockchain group that pulls together attorneys from a number of the firm’s top practices to help clients navigate this emerging technology.

Press Release
Schiff Hardin Advises on Public Offerings in Pharma, Tech Sectors
April 4, 2018

In the last 60 days, Schiff Hardin advised on the initial public offerings (IPO) for two companies and a public offering for another company, two in pharmaceuticals and one in the tech sector.

Alerts
USDA Clarifies Position on Plant Breeding Innovation, Including Gene Editing in Plants
March 29, 2018
Karen Ellis Carr, Stanley H. Abramson, Alexander H. Spiegler

Yesterday, USDA formally announced that it “does not regulate or have any plans to regulate plants” created using new breeding techniques, such as gene editing, as long as such plants “are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.”

Press Release
Nelson Quoted on Bayh-Dole Act as a Potential Tool to Regulate Drug Pricing
March 23, 2018

Partner Kevin Nelson was quoted on the Knowledge Ecology International’s urging of the National Institutes of Health (NIH) to leverage the Bayh-Dole Act in order to combat rising drug prices.

Health Care Counsel Blog
Patent Office’s Rulebook Update Supports Personalized Medicine Claims
February 20, 2018
Alexander H. Spiegler

Personalized medicine patent claims have been under assault since the Supreme Court’s Mayo v. Prometheus decision.

Alerts
EU Court Offers Preview of Potential Regulatory Approach for Gene Edited Plants
February 15, 2018
Karen Ellis Carr, Stanley H. Abramson, Katie Heilman

Late last month, an advisor to the Court of Justice of the European Union issued an opinion recommending that plants produced using innovative breeding techniques, like gene editing, be regulated like conventionally-bred plants rather than under the EU’s genetically modified organism Directive, the

News
Stephanie Trunk Selected by Corporate Counsel for 2018 Client Choice™ Award
February 2, 2018
Stephanie Trunk

Arent Fox Health Care partner and co-practice group leader Stephanie Trunk was nominated by corporate counsel to the 2018 Client Choice™ award list for the District of Columbia. Client Choice™ recognizes law firms and partners that stand apart for the excellent client service they provide.

Investigations Blog
Is DOJ Changing Its Approach to Enforcement? What Regulated Entities Need to Know 
February 2, 2018
D. Jacques Smith, Michael F. Dearington, Randall A. Brater

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies.

Events
Q1’s Annual Food Labeling Conference
January 29, 2018
Karen Ellis Carr, Emily Cowley Leongini

Karen Carr and Emily Leongini to Present at Q1’s Annual Food Labeling Conference. Arent Fox partner Karen Carr and associate Emily Leongini are scheduled to speak at the Q1 Productions’ 5th Annual Food Labeling Conference.

Events
New York State Bar Association Food, Drug & Cosmetic Law Section Annual Meeting and Reception
January 25, 2018
Karen Ellis Carr

Arent Fox will host the reception for the New York State Bar Association’s (NYSBA’s) Food, Drug & Cosmetic Law Section Annual Meeting on January 25th, 2018 in its New York office.

Investigations Blog
Another One Bites the Dust: Court Tosses Nearly $350 Million False Claims Act Verdict Under Escobar
January 24, 2018
D. Jacques Smith, Randall A. Brater, Michael F. Dearington

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court.

Health Care Counsel Blog
Medical Device Manufacturers Afforded Temporary Tax Relief
January 23, 2018
Dan H. Renberg

As was widely reported, Congress approved legislation late Monday, January 22, 2018 to provide continuing appropriations for federal agencies through February 8, 2018, ending the government shutdown that began Saturday.

Alerts
Biotech Policy Takes Shape: Rural Task Force Encourages Innovation and Regulatory Coordination
January 22, 2018
Alexander H. Spiegler, Karen Ellis Carr, Stanley H. Abramson
Alerts
Chemical & Life Sciences Patent: Year In Review 2017
January 19, 2018
Alexander H. Spiegler

This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.

Alerts
FDA Taps the Brakes on Certain Aspects of FSMA Compliance
January 17, 2018
Brian P. Waldman

Recently, the FDA announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety Modernization Act. 

News
Stephanie Trunk Quoted on PhRMA Drug Pricing Lawsuit in Bloomberg BNA
December 18, 2017
Stephanie Trunk

The Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit against the state of California in response to the state’s new drug price law. 

Alerts
Companies Marketing CBD Products Be Warned: FDA Is Watching
November 20, 2017
Emily Cowley Leongini

The US Food and Drug Administration recently issued warning letters to four companies.

Alerts
FTC Holds Public Workshop to Consider If Hatch-Waxman Is Working for Prescription Drug Competition
November 13, 2017
Stephanie Trunk

On November 8, 2017, the Federal Trade Commission held a workshop entitled, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.”

Press Release
U.S. News and Best Lawyers Rates 22 Arent Fox Practices Among Best in the Country
November 2, 2017

Twenty-two Arent Fox LLP practices have been recognized in the 2018 “Best Law Firms” rankings that are published annually by U.S. News & World Report and Best Lawyers.

News
Karen Carr Pens Food Labeling Article for Food Safety Tech
October 17, 2017
Karen Ellis Carr

When the National Bioengineered Food Disclosure Standard was signed into law last year, it represented the culmination of an extended period of regulatory and legislative activity on food labeling issues.

Alerts
More Controls Needed to Prevent Organic Import Fraud, Says USDA OIG
October 12, 2017
Karen Ellis Carr

The US Department of Agriculture needs to strengthen its controls over the approval and oversight of agreements for the import of organic products into the US, according to a recent audit report issued by the Office of the Inspector General at USDA.

Alerts
Another Front Opens Up on Food Disclosure
October 10, 2017
Karen Ellis Carr, Stanley H. Abramson

The food industry potentially faces a new challenge on disclosure at the local level with the recent passage of a San Francisco ordinance addressing antibiotic use.

Alerts
FDA Requires Pharma Companies to Certify Drug Listing Info
October 6, 2017
Stephanie Trunk, Emily Cowley Leongini

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations.

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