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Misleading Statements FDA Approval

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 7

New Suit Claims "Scientifically False" Pheromone Ads Are "Pure" False Advertising - "It's not myth. It's science." So claims Pure Instinct in its ads for pheromone perfumes. But a new class action lawsuit claims it's not...more

Arnall Golden Gregory LLP

This is a Land of Confusion: FDA Issues Q&A Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more

Cozen O'Connor

Connecticut AG Tong Doesn’t Want to Hear Claims that Over-the-Counter Hearing Aids Are “FDA-Approved”

Cozen O'Connor on

Connecticut AG William Tong announced that his office has settled with four over-the-counter hearing aid companies: Lively Hearing Corporation, Widex USA, Inc., Hark Wellness, Inc., and Wonder Ear, Inc. (collectively, “OTC...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Goodwin

Delaware Court of Chancery Finds that Director’s Email on Outside Email System Remains Confidential

Goodwin on

Delaware Court of Chancery Finds that Director’s Email on Outside Email System Remains Confidential; Delaware Supreme Court Overrules Longstanding Precedent Regarding Derivative Versus Direct Standing; SEC Files Crowdfunding...more

Mayer Brown Free Writings + Perspectives

Ninth Circuit Affirms Dismissal in Stock-Drop Lawsuit, Citing Shareholder’s “Implausible” Scienter Theory

On June 10, 2020, the US Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative securities fraud class action against Endologix, Inc., a medical device company, on the grounds that the shareholder’s core...more

Seyfarth Shaw LLP

District Courts In New Jersey And New York Dismiss Securities Class Actions Against Life Science Companies Emphasizing the High...

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The United States District Courts for the District of New Jersey and the Southern District of New York recently dismissed putative securities class action complaints filed against life science companies in Smith v. Antares...more

Pillsbury Winthrop Shaw Pittman LLP

When Speaking to Investors, Mix Facts with Predictions at Your Peril

The Private Securities Litigation Reform Act of 1995 protects “forward-looking statements”—that is, predictions about the future, at least when they are accompanied by “meaningful cautionary statements” that could cause the...more

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