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Pharmaceutical Industry › Securities Litigation › Food and Drug Administration (FDA)

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Pivots on Publishing Complete Response Letters, Raising SEC Disclosure and Securities Litigation Implications

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On July 10, 2025, the U.S. Food and Drug Administration (FDA) announced that it was embracing “radical transparency” by publishing more than 200 Complete Response Letters (CRLs) — letters the agency issues to a sponsor when...more

A&O Shearman

Western District Of Pennsylvania Denies Motion For Judgment On The Pleadings In Securities Class Action Against Pharmaceutical...

A&O Shearman on

On July 8, 2025, Judge Nicholas Ranjan of the United States District Court for the Western District of Pennsylvania denied a motion for judgment on the pleadings, allowing a putative securities class action to proceed against...more

King & Spalding

FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come

King & Spalding on

On July 10, 2025, the Food and Drug Administration (FDA) announced that it had published more than 200 complete response letters (CRLs), in response to applications submitted to the FDA for approval of drugs or biological...more

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

Cooley LLP

Second Circuit Highlights Difficulty in Pleading Fraud Claims Involving the Interpretation of Clinical Data

Cooley LLP on

Plaintiffs often file securities fraud claims against pharmaceutical companies alleging that the company misled investors about clinical data, despite the US Food and Drug Administration (FDA) subsequently approving the drug...more

Goodwin

California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO

Goodwin on

California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO; S.D.N.Y. Dismisses Ponzi Scheme Action Against HSBC Hong Kong for Lack of Personal Jurisdiction; Delaware Court of Chancery...more

Mayer Brown Free Writings + Perspectives

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

Mayer Brown Free Writings + Perspectives on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Ninth Circuit Holds That Courts Should Scrutinize Economic Plausibility of Securities Fraud Complaints in Evaluating Scienter

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On June 10, 2020, the Ninth Circuit affirmed the dismissal of a putative securities fraud class action in a potentially significant decision for securities defendants, particularly those in the pharmaceutical, biotech and...more

Skadden, Arps, Slate, Meagher & Flom LLP

Life Sciences Companies May Face More Scrutiny in Using FDA Documents to Dismiss Securities Cases

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Following a recent decision from the U.S. Court of Appeals for the Ninth Circuit in Khoja v. Orexigen Therapeutics, Inc., plaintiffs alleging securities fraud against companies in the pharmaceutical and life sciences sector...more

Bass, Berry & Sims PLC

Chris Lazarini Provides Insight on Application of Scienter in Securities Exchange Act Claim - Thought Leadership - Bass Berry

Bass, Berry & Sims PLC on

Bass, Berry & Sims attorney Chris Lazarini provided insight on case in which class plaintiffs allege certain company officers knowingly made misleading statements about a drug's potential adverse effects which, when later...more

Cadwalader, Wickersham & Taft LLP

2016 Year In Review: Securities Litigation And Regulation

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2016 was an active year in securities litigation. In the first half of 2016 alone, plaintiffs filed 119 new federal class action securities cases. It was also a busy year for SEC enforcement proceedings, with a record 868...more

Pierce Atwood LLP

First Circuit Affirms Tough Standard for Alleging Securities Fraud; Revives One Claim Against Local Drug Maker

Pierce Atwood LLP on

On November 28, 2016, the First Circuit upheld the dismissal of all but one of the class action securities fraud claims against Cambridge, MA drug company, ARIAD Pharmaceuticals, Inc., reaffirming the exacting pleading...more

Burr & Forman

Second Circuit Affirms District Court in Tongue v. Sanofi

Burr & Forman on

On March 4, 2016, the United States Court of Appeals for the Second Circuit affirmed the District Court for the Southern District of New York in Tongue v. Sanofi, No. 15-588-CV, 2016 WL 851797 (2d Cir. Mar. 4, 2016), holding...more

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