News & Analysis as of August 17, 2025

Prescription Drugs

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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

ArentFox Schiff on 7/14/2025

Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

5 Major Drug and Device Developments of 2022

Faegre Drinker Biddle & Reath LLP on 12/23/2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Novartis Agrees To $678 Million False Claims Act Settlement With SDNY For Sham Speaker Programs

Farrell Fritz, P.C. on 7/16/2020

Novartis Pharmaceuticals Corp. agreed earlier this month to pay $678 million to settle an SDNY False Claims Act case. The SDNY alleged that Novartis violated the False Claims Act and the Anti-Kickback Statute by giving...more

Novartis FCPA Enforcement Action: Fines, Penalties and the Cost of Recidivism

Thomas Fox - Compliance Evangelist on 7/1/2020

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

Novartis and Alcon FCPA Enforcement Action: Lessons Learned (Part III of III)

The Volkov Law Group on 7/1/2020

At the outset, Novartis is “lucky” – the settlement is relatively positive, despite its 2016 SEC enforcement action in China. Given Novartis weak culture of compliance (if anything, a better description may be a culture of...more

FDA Approves Pfizer’s Adalimumab Biosimilar ABRILADA

Goodwin on 11/19/2019

On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah...more

Financial Daily Dose 10.1.2019 | Top Story: Credit Suisse COO Resigns in Wake of Corporate Spying Scandal

Robins Kaplan LLP on 10/1/2019

Top Tidjane Thiam ally Pierre-Olivier Bouee, Credit Suisse’s COO, has resigned in the wake of an internal probe finding that he “ordered the surveillance of the bank’s former wealth-management chief, Iqbal Khan, without...more

Be Careful What You Say – Or Rather What You Don’t Say – AVEO Pays $4 Million to SEC to Settle Fraud Charges

Sullivan & Worcester on 4/22/2016

In March 2016, the Securities and Exchange Commission announced that AVEO Pharmaceuticals, Inc., a Massachusetts-based biopharmaceutical company, agreed, without admitting or denying the allegations, to pay $4 million to...more

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Foley & Lardner LLP on 3/14/2016

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more

New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion

Morrison & Foerster LLP on 12/18/2015

In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more

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