News & Analysis as of

Novartis Today's Popular Updates

BakerHostetler

A Later-Discovered Improvement to an Invention Cannot Be Used To Reach Back and Invalidate an Earlier-Filed Patent

BakerHostetler on

Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more

Goodwin

Life Sciences M&A Trends for 2023 and 2024 (Through End of Q3) in Greater China

Goodwin on

Goodwin is presenting a two-part publication series covering life sciences trends involving license deals, M&A, and financing for Greater China’s life sciences sector. ...more

Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

Venable LLP on

As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

Polsinelli

Regeneron v Novartis and Vetter: Walker Process Client Update

Polsinelli on

In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more

Fish & Richardson

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA...

Fish & Richardson on

As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more

Cozen O'Connor

AG Climate Change Suits Continue | Dunkin’ In Hot Water | CFPB And States Settle With Student Lender

Cozen O'Connor on

2022 AG Elections- Challenger Takes on Texas Incumbent Attorney General- •Joe Jaworski, former Mayor of Galveston Texas, announced his intention to seek the Democratic nomination for Texas AG to challenge Republican...more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 6 – Final Thoughts

We are nearing the end of this exploration of two major corruption enforcement actions involving the pharmaceutical giant Novartis. One in the US and one for the rest of the world....more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 4 – CIA Structural Requirements

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Akerman LLP - Health Law Rx

Novartis’ Simultaneous Settlements Break Records

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 3 – Compliance Failures

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Arnall Golden Gregory LLP

CIA Imposes Requirements for Pharmaceutical Speaker Programs and Events

On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 2 – The Corruption Schemes

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, that enforcement action paled next to two resolutions...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 1 – Introduction

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments For June 2020

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Farrell Fritz, P.C.

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

Farrell Fritz, P.C. on

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

Vinson & Elkins LLP

Novartis’ And Alcon’s $345 Million FCPA Case Signals Increased Scrutiny Of Gifts And Entertainment And New Focus On Scientific...

Vinson & Elkins LLP on

On June 25, 2020, Novartis AG, a Swiss multinational pharmaceutical company, and two subsidiaries reached a combined $345 million resolution with the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange...more

Thomas Fox - Compliance Evangelist

Everything Compliance-Episode 63, the Novartis edition

Welcome to the only roundtable podcast in compliance. Today, we have the full quintet of Jonathan Armstrong, Jay Rosen, Matt Kelly, Jonathan Marks and Mike Volkov sitting in to discuss various aspects of the Novartis...more

The Volkov Law Group

Episode 150 -- Novartis Settles False Claims Act and Anti-Kickback Cases for $729 Million

The Volkov Law Group on

Novartis is the new poster-child of corporate misconduct. In the space of two weeks, Novartis settled domestic False Claims Act and Anti-Kickback violations for $729 million, and settled FCPA violations for foreign bribery...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Data Analytics and Lessons Learned

This blog post will close my review of 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...more

Thomas Fox - Compliance Evangelist

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

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

A&O Shearman

Global Healthcare Company To Enter DPA, Pay $345 Million To DOJ And SEC, To Resolve FCPA Claims

A&O Shearman on

On June 25, 2020, Novartis AG, a global healthcare company headquartered in Switzerland, and two of its subsidiaries (one current and one former) agreed to pay a total of $345 million in disgorgement and fines to the U.S....more

The Volkov Law Group

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

The Volkov Law Group on

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

Thomas Fox - Compliance Evangelist

Compliance into the Weeds: Episode 178-the Novartis FCPA Enforcement Action

Compliance into the Weeds is the only weekly podcast which takes a deep dive into a compliance related topic, literally going into the weeds to more fully explore a subject. In this episode Matt Kelly and Tom Fox take a look...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Internal Controls

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

39 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide