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Pharmaceutical Industry › Food and Drug Administration (FDA) › Lanham Act

Troutman Pepper

Pioneer Drug Maker Throws First Punch At Pharmacy Outsourcing Facilities (503b)

Troutman Pepper on

Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

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On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Pillsbury Winthrop Shaw Pittman LLP

Despite Amarin, ITC May Be Right Prescription For Pharma

Pillsbury Winthrop Shaw Pittman LLP on

Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms that the ITC Cannot Investigate an FDCA Violation without the FDA’s Say-So

Mintz - Intellectual Property Viewpoints on

In Amarin Pharma, Inc. v. Int’l Trade Comm’n (18-1247), the Federal Circuit affirmed the International Trade Commission’s (“ITC”) finding that Amarin’s false advertising claim under § 43(a) of the Lanham Act was precluded by...more

Akin Gump Strauss Hauer & Feld LLP

The Federal Circuit Finds Jurisdiction over the ITC’s Decision Not to Institute an Investigation Under Section 337 and Explains...

Akin Gump Strauss Hauer & Feld LLP on

• The International Trade Commission (ITC) can decline to institute an investigation when a complaint fails to state a cognizable claim under Section 337 of the Tariff Act, 19 U.S.C. § 1337 (“Section 337”). • A decision...more

Wilson Sonsini Goodrich & Rosati

HHS Proposes New Rule Requiring Drug TV Advertisements to Include the Drug's Retail Price

Wilson Sonsini Goodrich & Rosati on

Prescription drug pricing in the U.S. has received significant and widespread attention lately from the media, consumers, and the government. For example, the Washington Post ran an article that examines the sometimes opaque...more

McGuireWoods LLP

Fireworks for Animal Drug Compounding at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part Two...

McGuireWoods LLP on

The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more

Faegre Drinker Biddle & Reath LLP

POM Wonderful™ News for Prescription Drug and Device Manufacturers?

Faegre Drinker Biddle & Reath LLP on

Last week, the Supreme Court decided that POM Wonderful™, maker of pomegranate juice, could sue Coca-Cola Company, maker of a blended juice product that included pomegranate and blueberry juices, under the Lanham Act for...more

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