News & Analysis as of

Securities Litigation Pharmaceutical Industry

A&O Shearman

Ninth Circuit Affirms Dismissal of Putative Class Action Against Pharmaceutical Company for Failure to Adequately Allege Falsity...

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On August 20, 2025, the United States Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative class action asserting claims under the Securities Exchange Act of 1934 against a pharmaceutical company and...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Snell & Wilmer

Securities Class Action Litigation Surges in Dollar Value Despite Steady Filing Numbers

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Cornerstone Research recently published its Securities Class Action Filings—2025 Mid-Year Assessment. The report contains useful data and information about the securities class action landscape thus far this year. The...more

A&O Shearman

District Of New Jersey Dismisses Putative Securities Class Action Against Pharmaceutical Company

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On July 30, 2025, Judge Brian R. Martinotti of the United States District Court of the District of New Jersey granted a motion to dismiss a putative securities fraud class action against a drug manufacturing company (the...more

A&O Shearman

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

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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

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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

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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

A&O Shearman

Northern District Of California Dismisses Securities Class Action Against Biopharmaceutical Company For Failure To Adequately...

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On May 5, 2025, Judge Yvonne Gonzalez Rogers of the United States District Court for the Northern District of California granted a motion to dismiss a proposed class action asserting claims against a biopharmaceutical company...more

A&O Shearman

Central District Of California Dismisses Putative Securities Class Action Against Healthcare Technology Company For Failure To...

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On April 18, 2025, Judge André Birotte Jr. of the Central District of California granted a motion to dismiss a putative class action asserting claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the...more

Woodruff Sawyer

Special Report: Biotechnology Companies & Securities Class Action Litigation (2024)

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In 2024, biotechnology companies were the second most targeted industry for securities class action litigation, according to the D&O Databox™, Woodruff Sawyer’s proprietary database of securities class action suits. The...more

Goodwin

Securities Litigation Against Life Sciences Companies 2024 Year in Review

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Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - December 2024

Key Points - - During its 2024 term, the U.S. Supreme Court is poised to provide important guidance on the Private Securities Litigation Reform Act’s (PSLRA’s) particularity requirement in NVIDIA Corp. v. E. Ohman J:or...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - October 2024

Ninth Circuit Affirms Dismissal of Insider Trading Claims Against Satellite Operator Investors Based on Stock Sales After FCC Chairman Vote - In re Silver Lake Grp., LLC Sec. Litig. (9th Cir. July 24, 2024) What to...more

A&O Shearman

Eastern District Of Pennsylvania Denies In Part Motion To Dismiss Putative Securities Class Action Against Pharmaceutical Company

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On September 3, 2024, Judge Mitchell S. Goldberg of the United States District Court for the Eastern District of Pennsylvania granted in part and denied in part a motion to dismiss a putative securities class action against a...more

A&O Shearman

Northern District Of California Dismisses With Prejudice Putative Class Action Against Pharmaceutical Company

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On May 7, 2024, Judge Beth Labson Freeman of the United States District Court for the Northern District of California dismissed with prejudice a putative shareholders’ class action against a pharmaceutical company (“Company”)...more

A&O Shearman

Second Circuit Affirms District Court’s Summary Judgment Dismissal Of Securities Fraud Class Action Against Pharmaceutical Company

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On April 15, 2024, the United States Court of Appeals for the Second Circuit affirmed in a non-precedential summary order the summary judgment dismissal of securities fraud claims against a pharmaceutical company (the...more

Jones Day

SEC Prevails in Novel "Shadow Trading" Insider Trading Trial

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The Securities and Exchange Commission ("SEC") won at trial in its first "shadow trading" case, holding a corporate official liable for insider trading for using nonpublic information about his company's acquisition to trade...more

A&O Shearman

Northern District Of California Court Partially Grants Motion To Dismiss Putative Securities Class Action Against Pharmaceutical...

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On March 11, 2024, Judge Haywood S. Gilliam, Jr. of the United States District Court for the Northern District of California granted in part and denied in part a motion to dismiss a putative securities class action brought...more

Cooley LLP

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

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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

A&O Shearman

Southern District Of New York Dismisses With Prejudice Claims Against Pharmaceutical Company Alleging Material Misstatements And...

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On December 28, 2023, Judge Jed S. Rakoff of the United States District Court for the Southern District of New York dismissed a putative class action alleging that a biopharmaceutical company (the “Company”) and certain of...more

A&O Shearman

Southern District Of New York Dismisses Proposed Securities Class Action Complaint Against Drug Manufacturer For Failure To Plead...

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On September 25, 2023, Judge Lorna Schofield of the United States District Court for the Southern District of New York granted a motion to dismiss a proposed class action against a biopharmaceutical company (the “Company”)...more

A&O Shearman

District Of New Jersey Allows Securities Fraud Claim To Proceed Against Outside Accounting Firm, Finding Plaintiff Sufficiently...

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On June 15, 2023, Judge Michael A. Shipp of the United States District Court for the District of New Jersey, in an unpublished opinion, adopted a Special Master’s Report and Recommendation denying a motion to dismiss claims...more

Goodwin

Second Circuit Upholds Dismissal of AstraZeneca Investor Suit

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On May 16, 2023, the US Court of Appeals for the Second Circuit affirmed the Southern District of New York’s order dismissing an action brought by investors of AstraZeneca PLC (AstraZeneca) attempting to hold the company...more

A&O Shearman

Second Circuit Affirms Dismissal Of Putative Class Action Against Pharmaceutical Company For Failure To Allege Misstatements and...

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On May 16, 2023, the United States Court of Appeals for the Second Circuit affirmed a district court’s dismissal of a putative class action asserting claims against a pharmaceutical company (the “Company”) under Sections...more

Bennett Jones LLP

Class Actions: Looking Forward 2023

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We begin with an update on a trilogy of privacy class actions appeals in which plaintiffs sought, unsuccessfully, to expand the tort of intrusion upon seclusion. Next, we canvass the various approaches of Ontario courts...more

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