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Settlement Agreements Food and Drug Administration (FDA)

Venable LLP

Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars

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On June 2, 2025, Sandoz announced the launch of Jubbonti® / Wyost® (denosumab-bbdz), the first Prolia® / Xgeva® (denosumab) interchangeable biosimilars to launch in the U.S....more

Robins Kaplan LLP

ANDA Litigation Settlements

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Reported settlements in federal district court cases - This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Cozen O'Connor

Nebraska AG Settles Delta-8 Lawsuits Against Four Retailers

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Nebraska AG Mike Hilgers has announced four additional settlements in a series of lawsuits filed against retailers for allegedly selling mislabeled and harmful products containing synthetic THC in violation of Nebraska’s...more

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

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Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - April 2024

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This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more

Goodwin

Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

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​​​​​​​On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....more

Goodwin

Alvotech Announces More Settlements and Expected Launch Dates Regarding Biosimilar to STELARA (ustekinumab), AVT04

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On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and...more

American Conference Institute (ACI)

[Event] Drug & Medical Device Litigation - December 5th - 6th, New York, NY

Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Humira’s End of Reign

On March 8, 2022, Alvotech announced that it has executed a U.S. settlement agreement with Abbvie that grants Alvotech non-exclusive rights to market AVT02 (adalimumab) in the U.S starting July 1, 2023. AbbVie confirmed the...more

Patrick Malone & Associates P.C. | DC Injury...

Big Pharma is hard to rein in. Just look at two drug cases grabbing headlines.

Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits - in settling claims over distributors...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Products Liability Insights: Issue 2, 2020

Welcome to 2020's second edition of Product Lines, our e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal issues. As you will...more

Goodwin

FDA and FTC Announce Collaboration to Support Biosimilars Market

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The U.S. Food and Drug Administration and the Federal Trade Commission today released a joint statement regarding collaboration to advance competition in the market for biologic products. According to the FDA press release,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Searcy Denney Scarola Barnhart & Shipley

Is the CPSC Leaving Consumers 'Holding the Bag'?

Product Recalls to Protect the Consumer? Is the Consumer Product Safety Commission, a federal agency charged with protecting the safety of Americans from dangerous and deadly items in the marketplace, doing its job? A...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Robins Kaplan LLP

Amgen Inc. v. Amneal Pharms. LLC

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The Court Denied Defendant’s Motion To Enforce Its Settlement Agreement With Plaintiff After The At-risk Launch And Subsequent Settlement Of Another Defendant. ...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l November 2019

LEGISLATION, REGULATIONS & STANDARDS - USDA Issues Interim Rule On Hemp Production - The U.S. Department of Agriculture (USDA) has issued an interim final rule “specifying the rules and regulations to produce hemp.” The...more

Robins Kaplan LLP

Financial Daily Dose 10.21.2019 | Top Story: Four Drug Companies Reach Last-minute Deal to Avoid Start of Federal Opioid Trial

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A last-minute deal between defendants McKesson, Cardinal Health, AmerisourceBergen, and Teva and plaintiffs’ attorneys means that multidistrict opioid epidemic litigation set to kick off in Ohio federal court today will not...more

Patrick Malone & Associates P.C. | DC Injury...

$8 billion Risperdal verdict? It’s not the money, it’s the message, Big Pharma

When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and...more

Patrick Malone & Associates P.C. | DC Injury...

Big Pharma flinches in opioids suits: a J&J loss in Okla. and a Sackler bid

Big Pharma has hit at least two pain points of potential significance as government officials and trial lawyers work to hold drug makers accountable for at least some of the carnage caused by prescription painkillers....more

Robins Kaplan LLP

ANDA Litigation Settlements - Spring 2019

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Please see Chart below for more information....more

Patrick Malone & Associates P.C. | DC Injury...

$1 billion+ may seem like a lot of money. It still can’t resolve many questions.

Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l March 2019 #3

LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Webinar on Genome Editing in Animals - The U.S. Food and Drug Administration has announced an April 25, 2019, public webinar about “genome editing in animals, an...more

Goodwin

Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars (Updated)

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Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’...more

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