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Department of Justice (DOJ) Biotechnology

MoFo Life Sciences

Microbes, Biotech Investigations, And Impacts: Midsummer Regulatory Updates From USDA-APHIS

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After overhauling its biotechnology regulations for plants developed using genetic engineering, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Goodwin

The BIOSECURE Act and Its Potential Implications

Goodwin on

Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more

Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

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Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more

American Conference Institute (ACI)

[Event] 18th Annual FCPA & Anti-Corruption for the Life Sciences Industry - May 10th - 11th, New York, NY

Hosted by American Conference Institute, the 18th Annual Conference on the FCPA & Anti-Corruption for the Life Sciences Industry returns for another exciting year with curated programming that shines a global spotlight on...more

Goodwin

Antitrust & Competition Life Sciences 2022 Year In Review

Goodwin on

M&A activity in the life sciences space proceeded largely as usual in 2022, with most transactions receiving expected levels of agency scrutiny and closing in the normal course despite aggressive rhetoric from new leadership...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – January 2023

Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on interlocking boards in the life sciences sector and the antitrust risk they pose to firms and investors;...more

MoFo Life Sciences

Prevent A Clinical Trial From Turning Into A Criminal Trial

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On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more

Sheppard Mullin Richter & Hampton LLP

Biogen Settlement Summary

On Monday September 26, the Department of Justice announced a settlement resolving a lawsuit filed by former employee Michael Bawduniak (the “Plaintiff”) against Biogen Inc. (the “Company”) under the qui tam provisions of the...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

Morgan Lewis

Speaker Program Compliance: Biotech Company Settles False Claims Act Allegations for $900 Million

Morgan Lewis on

Biogen Inc., a global biotechnology company, denies that it violated the federal Anti-Kickback Statute and False Claims Act by paying healthcare professionals for fraudulent speaking engagements in order to incentivize them...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 7th - 8th, New York, NY

The premier event for drug and medical device product liability lawyers to gain essential winning litigation strategies. ACI’s 26th Annual Flagship Conference on Drug and Medical Device Litigation is returning to New York...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights, Volume 2, Issue 7

Supreme Court Rules in Google’s Favor in Copyright Dispute with Oracle Over Android Software - After the Supreme Court's April 6 decision in Google LLC v. Oracle America, Inc., 141 S.Ct. 1183 (2021), the computer software...more

Arnall Golden Gregory LLP

Life Sciences Investigations – 2020 Year in Review and 2021 Outlook

On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more

Fox Rothschild LLP

Key Steps The Pharma And Bioscience Sectors Must Take Ahead Of Federal Scrutiny Of COVID-19 Relief Funding

Fox Rothschild LLP on

An unprecedented explosion of government investigation and enforcement is at hand as federal regulators focus their efforts on ferreting out any fraud or abuse of the $1 trillion in COVID-19 relief funding programs through...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

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On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Wilson Sonsini Goodrich & Rosati

2019 Life Sciences Securities Litigation Roundup

2019 Filings - In 2019, the number of securities class action cases filed against life sciences companies reached record levels. According to Cornerstone Research, lawsuits against pharmaceutical companies increased by 40...more

Robins Kaplan LLP

Financial Daily Dose 2.6.2020 | Top Story: Feds Probing Google’s Ad Business Over Antitrust Concerns

Robins Kaplan LLP on

More detail is emerging on the DOJ’s ongoing antitrust probe into Google, with recent attention to the company’s online ad tools suggesting the topic has become “a major focus of the investigation,” with special focus on “how...more

Jones Day

SEC Enforcement in Financial Reporting and Disclosure: 2019 Year-End Update

Jones Day on

We are pleased to present our annual year-end update on financial reporting and issuer disclosure enforcement activity for 2019. This White Paper focuses on the U.S. Securities and Exchange Commission's ("SEC") enforcement...more

American Conference Institute (ACI)

[Event] Drug and Medical Device Litigation – the Must-Attend Event for the Life Sciences Products Liability Community - December...

Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more

Robins Kaplan LLP

Financial Daily Dose 6.4.2019 | Top Story: DOJ Mulling Google Antitrust Action

Robins Kaplan LLP on

The DOJ is considering joining its European counterparts in targeting Google for potential antitrust violations focused on Google’s “advertising practices and influence in the online advertising industry,” possibly including...more

Wilson Sonsini Goodrich & Rosati

2018 Life Sciences Securities Litigation Roundup

2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more

Knobbe Martens

Bayer and Monsanto Deal Gets Blessed

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Since May of 2016, Bayer and Monsanto have been working on a deal to combine the two giants. Based on a report released by the Wall Street Journal on Monday, April 9, 2018, the U.S. Department of Justice has just given its...more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

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