GlaxoSmithKline

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Shakespeare Week – Part V: Lear’s Fool and Power Points

I conclude my week honoring the 400th anniversary of the death of Shakespeare by using my favorite character in all his work to introduce today’s post. He is The Fool from King Lear. Of Shakespeare’s many theatrical...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

EU & Competition Law Update - March 2016

Welcome to March's edition of our EU & Competition Law Bulletin covering recent legal developments impacting upon you and your business: - ..United Kindgdom: Large pay for delay fine imposed by CMA. ..Germany and...more

Liability for Brand Drug Manufacturers All But Clear

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more

AGG Food and Drug Newsletter - February 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Government Charges Five, Including Two Scientists, With Stealing Trade Secrets And Confidential Information From GlaxoSmithKline

On January 20, 2016, the United States Attorney’s Office for the Eastern District of Pennsylvania announced the indictment of five people, including two research scientists at GlaxoSmithKline (“GSK”), on charges of stealing...more

Antitrust Fines for Pharma Pay-for-Delay: the UK Gets in on the Act

On February 12, 2016, the United Kingdom (UK) Competition and Markets Authority (CMA), the UK’s antitrust regulator, handed out a huge fine for a pay-for-delay antitrust law infringement in the UK. Although the CMA has been...more

Large ‘pay for delay’ fine imposed by CMA

On the 12th of February 2016, the UK Competition and Markets Authority (CMA) fined GlaxoSmithKline (GSK) and the successor companies to Alpharma Limited around £45m in total for breaches of Chapter I of the Competition Act...more

Zofran Morning Sickness Lawsuit and Birth Defects

If you took Zofran to treat the symptoms of morning sickness during your pregnancy and your baby has a serious birth defect, you may be able to file a product liability claim. According to a recent article in Reuters, federal...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

The Third Circuit Gives the Green Light to RICO Plaintiffs Seeking to Recover Payments for Prescription Drugs

This week, the Third Circuit altered the legal landscape for civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims against pharmaceutical companies. The ruling in In re Avandia Marketing, Sales Practices &...more

Ohio Couple Says Zofran Caused Infant’s Death

In 1991, the Food and Drug Administration (FDA) approved Zofran, which is manufactured by GlaxoSmithKline LLC (GSK) for use in cancer patients who require chemotherapy or radiation therapy. An Ohio couple has sued GSK, the...more

Red Notice Newsletter - August 2015

Welcome to the August 2015 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange...more

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

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