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Pfizer Department of Justice (DOJ)

Goodwin

Antitrust & Competition Life Sciences Year in Review 2023

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Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...more

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q2 2023

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The second quarter saw significant enforcement and dealmaking in the life sciences space. The Federal Trade Commission (FTC) announced its attempt to block Amgen/Horizon, the first such challenge to a life science transaction...more

Goodwin

Antitrust & Competition Life Sciences 2022 Year In Review

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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

Goodwin

Antitrust & Competition Life Sciences Quarterly Update - Q3 2022

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The third quarter in the life sciences space showed that business is generally proceeding as usual, with large pharma players successfully acquiring or licensing in clinical stage assets without running into antitrust delays....more

Wilson Sonsini Goodrich & Rosati

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more

Sheppard Mullin Richter & Hampton LLP

Day One Notes for the 40th Annual J.P. Morgan Healthcare Conference, 2022

For those of you who know me, I like to have fun with my Zoom backgrounds – choosing photos of interesting scenery or changing them mid-call to reflect my mood or negotiating strategy. Sitting in front of my computer this...more

Holland & Hart LLP

FDA Fully Approves Pfizer-BioNTech COVID-19 Vaccine: Implications for Employers

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Yesterday, the U.S. Food and Drug Administration (FDA) granted “full approval” to the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. In other words, the Pfizer-BioNTech vaccine (which will now be...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

FDA’s Full Stamp of Vaccine Approval Delivers Progress, but Issues With Vaccine Passports and Policies Are Looming

On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine. Moderna’s expedited application for full approval is still pending, and Johnson & Johnson plans to submit its...more

Goodwin

Year in Review: Top Five Biosimilar Legal Developments of 2018

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Here are our picks for the top five most significant legal developments of 2018 that may impact the biosimilar industry: 1. New Law Requiring FTC/DOJ Review Of Biosimilar Patent Litigation Settlements - With the...more

The Volkov Law Group

Anti-Corruption Risks and Drug and Device Companies

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For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

The Volkov Law Group

E-Mail Communications: The Devil is on the Server

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It is hard to imagine how prosecutors were able to bring cases before there was email communications. When I was a prosecutor, we looked for evidence in a lot of other sources, internal memos, calendars and other places where...more

Robins Kaplan LLP

Your daily dose of financial news - The Brief – 8.23.16

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The 2d Circuit has refused the DOJ’s motion for reconsideration of the panel’s May decision overturning a jury verdict and accompanying $1.27 billion fine against Bank of America over its “Hustle” mortgage generation program....more

Dorsey & Whitney LLP

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

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The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

Robins Kaplan LLP

Your daily dose of financial news The Brief – 4.7.16

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The DOJ has moved to block the proposed Halliburton/Baker Hughes merger in a Delaware-based federal lawsuit that argues that “combining the two oil field services companies would cut competition in the industry to...more

Morgan Lewis

DOJ Fraud Section Retains Hui Chen as Compliance Counsel Expert

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Chen brings important industry experience to the role. The Department of Justice (DOJ) Fraud Section has retained Hui Chen as a “full-time compliance expert.” Ms. Chen comes to the position with compliance counseling...more

Thomas Fox - Compliance Evangelist

A Farewell To Dr. Randolph And Making Your Compliance Program Effective

Dr. Henry Randolph died this week. He was a well-known expert in the field of dairy science. ...more

Sheppard Mullin Richter & Hampton LLP

Pfizer FCPA Settlement Emphasizes the Importance of Robust Compliance Programs for the Healthcare Industry

The healthcare industry has been under increased SEC and DOJ scrutiny lately for potential FCPA violations. What has been described as an “industry sweep,” has focused primarily on medical device and pharmaceutical companies....more

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