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Antitrust & Trade Regulation Science, Computers & Technology

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FTC Enforcement of COPPA for Internet of Things Reaches Flashpoint

by Morgan Lewis on

Galvanized by a confluence of charged factors—like privacy, cybersecurity, children, and the Internet of Things (IoT)—and sparked by recent assertions of Children’s Online Privacy Protection Act (COPPA) regulatory power, the...more

The Proposed Overhaul Of North Carolina’s Data-Breach Law Could Have Big-Time Consequences

by Ellis & Winters LLP on

One might expect N.C. Gen. Stat. § 75-1.1 to play a big role in data-breach litigation. The statute, after all, offers the prospect of treble damages and attorney fees. But, historically, it hasn’t. Only three...more

ICYMI: PrivSec’s Weekly News Picks

by Davis Wright Tremaine LLP on

Tech Republic reports that “the executive order may help bring internet to previously hard to reach areas, something several ISPs have been working towards.” “A more connected country”, author Olivia Krauth reports, “could...more

Financial Services Weekly News - January 2018

by Goodwin on

Editor's Note - A Busy Holiday Season. We hope that all of you had a happy holiday season and wish everyone a happy, healthy and prosperous new year. While the Roundup has been on hiatus during the holidays, the federal...more

FTC Announces Settlement Involving Connected Toys

by Kelley Drye & Warren LLP on

Earlier this week, the FTC announced its first settlement involving internet-connected toys. The FTC alleged that the Kid Connect app used with some of VTech’s toys collected personal information from hundreds of thousands of...more

State Of Louisiana, As Absent Class Member, Escapes CAFA Settlement Trap

by Carlton Fields on

The Third Circuit Court of Appeals affirmed a Pennsylvania district court decision holding the Eleventh Amendment to the United States Constitution prevented a private party from enjoining the state of Louisiana from bringing...more

Bitcoin, Blockchain and Consumer Protection Laws

by Holland & Knight LLP on

• Unsophisticated consumers eager to make a profit remain susceptible to representations by companies that are false and misleading, and constitute deceptive acts or practices in violation of the Federal Trade Commission...more

Beware of the Man-in-the-Middle: Lessons from the FTC’s Lenovo Settlement

by Patrick Law Group, LLC on

The Federal Trade Commission’s recent approval of a final settlement with Lenovo (United States) Inc., one of the world’s largest computer manufacturers, offers a reminder that when it comes to consumers’ sensitive personal...more

Net Neutrality: From Rules to Enforcement

To say that strong passions have surrounded the recent Federal Communications Commission vote to reverse 2015’s net neutrality rules is putting it mildly. There are stories that FCC Chairman Ajit Pai has endured racist...more

Digital Antitrust – Outlook for the European Antitrust Year 2018

by Hogan Lovells on

With the New Year only a few days old, we want to present a short outlook what to expect from European antitrust enforcement in 2018, with a particular focus on Germany. ...more

FTC Not in Love With AdoreMe’s Marketing

The Federal Trade Commission showed no love for an online lingerie marketer’s negative option membership program when it reached a settlement that requires AdoreMe to return more than $1.3 million to customers....more

French Competition Authority Fines a Pharmaceutical Laboratory EUR 25 Million for Anti-Generic Practices

by McDermott Will & Emery on

On 20 December 2017, the French Competition Authority (the FCA) imposed a EUR 25 million fine on a pharmaceutical laboratory, for delaying entry onto the market of the generic version of Durogesic, and for hindering its...more

FDA Publishes Best Practices for Communication Between IND Sponsors and FDA During Drug Development

by Goodwin on

Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance is intended to “describe best practices and...more

Federal Trade Commission Approves Settlement with Lenovo Over Ad Software

The Federal Trade Commission (FTC) has approved its proposed settlement with Lenovo, Inc. over the installation of pre-installed advertising software called VisualDiscovery onto Lenovo laptops. According to the FTC, the...more

FDA Guidance on Decision Support Software: Implications for Industry

by Epstein Becker & Green on

On December 8, 2017, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Clinical and Patient Decision Support Software” (“CDS Guidance”). According to FDA Commissioner Scott Gottlieb, M.D., the CDS...more

Non-Infringement of a Patent Also Not an Antitrust Injury

by McDermott Will & Emery on

Wading into the merging streams of antitrust and patents, the US Court of Appeals for the Ninth Circuit upheld dismissal of an antitrust suit where a jury verdict in a parallel case found no patent infringement. Cascades...more

FTC Discusses Informational Injury

Opening the Federal Trade Commission’s workshop on informational injury, Acting Chair Maureen K. Ohlhausen said the government “does the most good with the fewest unintended side effects when it focuses on addressing actual...more

Year in Review: The Top-Five U.S. Market Developments of 2017

by Goodwin on

Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more

Year in Review: Top 5 Foreign Market Developments in 2017

by Goodwin on

Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2017...more

Federal Circuit Rules BPCIA Preempts State Law

by Jones Day on

On December 14, 2017, the U.S. Court of Appeals for the Federal Circuit again interpreted the Biologics Price Competition and Innovation Act ("BPCIA"). In Amgen Inc. et al. v. Sandoz Inc., 15-cv-1499 (Fed. Cir. 2017), the...more

Federal Circuit Finds Preemption Of State Law Penalty For Sitting Out Biosimilar Patent Dance

by Foley & Lardner LLP on

The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more

China FDA Solicits Comments on Conditional Approvals for New Drugs and Compassionate Use of Investigational Drugs

by Ropes & Gray LLP on

The China Food and Drug Administration (“CFDA”) recently proposed two draft circulars for public comments, namely (a) the Technical Guidelines for Conditional Approvals for Urgently Needed Drugs (“Draft Conditional Approvals...more

American College of Rheumatology Identifies Six Factors for Future FDA Biosimilar Oversight

by Goodwin on

In response to an FDA request for comments regarding existing requirements for biologics and biosimilars, the American College of Rheumatology (ACR) submitted a letter identifying six “minimum components of review and...more

Delaware Supreme Court Clarifies Significance of Deal Price in Appraisal Cases

• For the second time in 2017, the Delaware Supreme Court reversed a Chancery Court’s decision to assign little or no weight to deal price in appraisal cases • In both cases, the court remained firm in its decision not to...more

FDA Accepts Samsung Bioepis’ aBLA for Herceptin® Biosimilar

by Goodwin on

Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states...more

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