GlaxoSmithKline

News & Analysis as of

Objections to Magistrate’s R & R are overruled in pharma case.

Stark, C. J. Defendants’ objections to the Magistrate’s Report and Recommendation are overruled. Defendants’ motions are granted in part and denied in part to the same extent as in the Report. ...more

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

GlaxoSmithKline LLC. v. Glenmark Generics Inc.

Case Name: GlaxoSmithKline LLC. v. Glenmark Generics Inc., USA, Civ. Nos. 14-877-LPS-CJB; 14-878-LPS-CJB, 2015 U.S. Dist. LEXIS 52525 (D. Del. Apr. 22, 2015) (Burke, J.) - Drug Product and Patent(s)-in-Suit: Coreg®...more

Sowing Uncertainty: Navigating Patent Disputes and Antitrust Scrutiny Post King Drug

On June 26, 2015, the Third Circuit issued an opinion in King Drug Co. of Florence, Inc. v. Smithkline Beecham Corp., (Case No. 14-1243). King Drug. The opinion, which already has been extensively commented on and...more

More Lawsuits Filed Against the Makers of Zofran

Zofran (ondansetron) is an anti-nausea medication made by GlaxoSmithKline (“GSK”). In 1991, the Food and Drug Administration (“FDA”) approved it for chemotherapy patients with severe nausea and vomiting. However, it has been...more

What Would Dr. Seuss Say about an Allowance?

Earlier this month we had the release of a second book by Harper Lee, “Go Set a Watchman”, which was miraculously discovered having been written some 50+ years ago. This week, there was another release from a (now deceased)...more

GlaxoSmithKline Files Motion To Consolidate Zofran Litigation In Philadelphia

Zofran was developed to prevent nausea and vomiting caused by cancer chemotherapy. However, doctors prescribed it for the treatment of morning sickness in pregnant women. GlaxoSmithKline is the world’s seventh largest...more

Why Should Americans Care About the FIFA Indictments? Part I – Only the US Government Could Do It

A colleague recently posed that question to me. I thought it was an interesting one and although at first blush the response to me might appear self-evident, the fact that it was posed means that my view may not be universal....more

Lunch with the FCPA Compliance and Ethics Blog – Donald Anderson of TDI

I recently had the chance to sit down for a lovely lunch at the Federal Grille with Donald Anderson, the Partner in Charge for TD International’s (TDI) Houston Office. Donald is a Louisiana native who attended LSU, receiving...more

Compliance Risk Logic’s Mastering Compliance in International Markets Conference

If you are in the Far East there is now a master conference centered around the top compliance practitioners in the region. Next month, from June 8-9, Compliance Risk Logic is putting on its a conference in Singapore,...more

International Anti-Corruption Enforcement Efforts

While the US Foreign Corrupt Practices Act (FCPA) is still the most widely recognized and enforcement anti-bribery and anti-corruption law across the globe, there have been a number of initiatives which will lead directly to...more

When You Hear Hoofbeats: GSK Soundly Defeats Time-Barred Thalidomide Claims

A couple of weeks ago, we saw a concert by the Fab Faux (we love that name), widely considered to be one of the best Beatles cover bands touring today. A Fab Faux concert is a tribute, not an impersonation. For one thing,...more

FTC Looks to Accelerate Oncology Drug Growth by Requiring Novartis to Divest Two Protein Inhibitors in Its Clinical Development...

The Federal Trade Commission (“FTC”) on Monday completed its review of Novartis AG’s (“Novartis”) proposed $16 billion acquisition of GlaxoSmithKline’s (“GSK”) oncology drug portfolio with an announced consent decree that...more

Africa Update - February 2015

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub - Saharan Africa - General Africa News - Excerpt from Leading the...more

"United Kingdom: The SFO Focuses on Corporate Fraud and Corruption"

Once the subject of speculation regarding its possible consolidation with other agencies, the Serious Fraud Office (SFO) had an exceedingly busy 2014, with all signs suggesting that it will continue its aggressive enforcement...more

Both Sides Now and Asking the Right Compliance Questions

One of my favorite singers has always been Judy Collins. Like most of us, I was introduced to her through her interpretation of Joni Mitchell’s song Both Sides Now which she released in 1967. Joni Mitchell did not record her...more

FCPA Compliance and Ethics Report-Episode 121-FCPA Year in Review, Part II [Video]

In this episode I review the two Opinion Releases, Esquenazi court decision, DOJ communications via speeches on FCPA enforcement. I end with a look at 2015. ...more

The FCPA Year in Review: Twist and Shout (Part I of II)

We all like annual reviews and predictions for the upcoming year – it is a New Year’s rite of passage and one that brings perspective and a sense of order to our otherwise chaotic lives....more

Damages in “Aggravated Breach” Cases

We have written before about the “aggravated breach of contract” theory under N.C. Gen. Stat. § 75-1.1. This theory can make a breach of contract a springboard to treble damages....more

Court Report -- Part II: November 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al. 2:14-cv-06627; filed November 19, 2014 in the Eastern District of...more

Critiquing FCPA Enforcement and the GSK Domestic Corruption Conviction

Recently the FCPA Professor posted a blog, entitled “Look in the Mirror Moments”, in which he used written commentary by the US Secretary of the Treasury to the Chinese government about the Chinese governments anti-trust...more

Africa Update - October 2014 #4

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

Court Decisions in the U.S. and China Bolster Law Enforcement’s Ability to Prosecute Global Corporate Corruption

On October 6, 2014, the United States Supreme Court declined to accept an appeal involving violations of the Foreign Corrupt Practices Act (“FCPA”)—the U.S. statute that criminalizes the bribing of foreign officials. The...more

Cross-Border Investigations Update - October 2014

In This Issue: Cross–Border Enforcement Trends: - Market Abuse - Economic Sanctions - Cross-Border Tax Enforcement - Anti-Corruption - Antitrust - A New Enforcement Environment in...more

GSK as a Watershed in the International Fight Against Bribery and Corruption

GlaxoSmithKline PLC (GSK) may well be a watershed in the global fight against bribery and corruption. Behavior and conduct, which was illegal under Chinese law but previously tolerated and even accepted by Chinese government...more

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