News & Analysis as of

Shareholders Pharmaceutical Industry

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

Paul Hastings LLP

Biotech Spin-Off Transactions

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As we previously discussed (here and here), the biotech mergers and acquisitions market currently faces significant headwinds. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug...more

Knobbe Martens

Zydus Lifesciences in Discussions to Acquire Majority Stake in Amplitude Surgical for €256.8m ($277.4m)

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Zydus Lifesciences Limited announced on March 11, 2025, that it entered into an agreement to acquire a majority stake in Amplitude Surgical. Reports state that Zydus Lifesciences has a tender offer agreement with PAI...more

Cooley LLP

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

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Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more

Goodwin

Life Sciences Licensing and M&A Update: Catching Up on Recent Decisions Affecting Commercially Reasonable Efforts Definitions and...

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Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more

ArentFox Schiff

The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need...

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Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more

Alston & Bird

Class Action & MDL Roundup 2023 Q4 - Not All Cases Survive and Advance

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Welcome to the Class Action & MDL Roundup, our quarterly review of decisions and settlements in the class action arena. In this edition, student-athletes win an NIL round, Canadians in California isn’t personal...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

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Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

McDermott Will & Schulte

VBC Symposium 2023 | Washington Update

During this session, Mara McDermott, Vice President, McDermott+Consulting, moderated a panel that discussed the current political and policymaking environment on Capitol Hill and what to watch for in 2023....more

DarrowEverett LLP

AmeriSource Decision a Difficult Pill to Swallow for Securities Plaintiffs

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The opioid crisis has garnered nationwide attention for decades and has resulted in thousands of lawsuits, subjecting pharmaceutical distributors to billions of dollars in damages. AmerisourceBergen (“Amerisource”) — one of...more

Goodwin

Delaware Court Of Chancery Dismisses Remainder 0f Claims Alleging that California Biotech Firm Profited From Nonpublic Information...

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On June 3, 2022, the Delaware Court of Chancery dismissed the final two counts in an action against California biotech firm Vaxart, Inc., finding that plaintiffs failed to adequately allege that certain non-public information...more

Goodwin

Delaware Federal Court Dismisses Shareholder Derivative Suit Concerning Lack of Board Diversity

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Delaware Federal Court Dismisses Shareholder Derivative Suit Concerning Lack of Board Diversity; California Federal Court Dismisses Shareholder Class Action Against Sorrento Therapeutics Regarding COVID-19 Treatment; Delaware...more

Goodwin

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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

Hong Kong Regulatory Update - July 2020

This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Cadwalader, Wickersham & Taft LLP

Delaware Court of Chancery Finds No Showing of Actionable Claim Required to Inspect Books and Records

In Lebanon County Employees’ Retirement Fund, et al. v. AmerisourceBergen Corporation, the Delaware Court of Chancery ordered the inspection of the books and records of AmerisourceBergen Corporation, one of the leading opioid...more

Herbert Smith Freehills Kramer

Delaware Chancery Court Holds That Stockholders Had a “Proper Purpose” to Seek Board Materials From Opioid Distributor, and Orders...

In a 63-page decision issued on Jan. 13, 2020, in Lebanon County Employees’ Retirement Fund v. AmerisourceBergen Corporation, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery found that stockholders of...more

BCLP

Securities and Corporate Governance Update – October 2019

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This newsletter discusses noteworthy updates, key regulatory decisions and upcoming compliance reminders. In this edition, we review: ...SEC Changes Approach to Shareholder Proposal No-Action Requests ...SEC Issues...more

Orrick, Herrington & Sutcliffe LLP

What's New in Corporate Governance and Securities Law - October 18, 2019

Corporate Governance and Securities Law Developments - Directors Can Be Held Liable for Failure to Oversee “Mission Critical” Regulatory Compliance - On October 1, the Delaware Court of Chancery refused to dismiss a...more

Foley Hoag LLP

Product Liability Update: April 2016

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United States Supreme Court Permits Class Certification And Proof of Liability Through Statistical Evidence Based on Class Sampling Where Class Was Sufficiently Uniform That Evidence Would Have Been Admissible in Any Class...more

Morris James LLP

Court Of Chancery Denies Standing After Spin-Off

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After a spin–off of a subsidiary, there is a question as to whether the subsidiary’s stockholders have standing to bring a derivative suit on behalf of the subsidiary for past wrongs against the subsidiary committed by the...more

Stinson - Corporate & Securities Law Blog

Say-On-Pay Vote Did Not Create Disclosure Obligation

In Liang v. Berger, the plaintiff in a derivative action alleged the officers and directors of ARAID Pharmaceuticals failed to disclose material negative information about a drug under development in a timely manner. Among...more

BakerHostetler

Genzyme First Circuit Decision

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In a huge victory for Massachusetts-based biologics manufacturer Genzyme Corporation, the First Circuit Court of Appeals on June 5, 2014 affirmed the District Court’s dismissal of a multi-million dollar shareholder class...more

Katten Muchin Rosenman LLP

Delaware Court of Chancery Invalidates Consent Due to Inadequate Disclosures

The Delaware Court of Chancery recently invalidated a written consent of a Delaware pharmaceutical corporation due to inadequate disclosures to stockholders. ...more

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