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BCLP

Selected Recent Developments for Public Companies

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Public companies should take note of several recent developments, including: ..Reversal of the Pegasystems trade secrets lawsuit that nevertheless preserves guidance to take care when describing litigation as “without...more

ArentFox Schiff

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

ArentFox Schiff on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Insights – June 2024

Explore the unique considerations for mergers and acquisitions in the AI sector, the return of IPOs, the implications of new Supreme Court decisions and other developments in this edition of Skadden’s quarterly Insights....more

Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

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Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more

Mintz - Health Care Viewpoints

FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to Stakeholders

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding...more

King & Spalding

FDA Publishes White Paper on Artificial Intelligence & Medical Products

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On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Mintz - Health Care Viewpoints

FDA Faces Critical Deadlines in 2024, Even Without an Election Looming

The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump. What the majority may not...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - December 2023

The U.S. Supreme Court will likely decide before the end of its current term whether the failure to make a disclosure pursuant to Item 303 of Regulation S-K can serve as the basis for a securities fraud claim under Section...more

Foley & Lardner LLP

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

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After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...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

Perkins Coie

Cannabis Legal Report - June 2023

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Coalition Forms To Influence Scheduling Review Process - As the Biden administration actively reviews the classification of cannabis under the Controlled Substances Act (CSA), a diverse group of cannabis companies and...more

Epstein Becker & Green

Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care

On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of...more

McDermott Will & Emery

New Cosmetics Regulatory Scheme to Reshape Industry’s Relationship with FDA

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The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) went into effect with US President Joe Biden’s signing of the Consolidated Appropriations Act, 2023. This legislation will profoundly change the way cosmetic...more

Jackson Lewis P.C.

FDA Names First Acting Director Of Medical Device Cybersecurity

Jackson Lewis P.C. on

The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created...more

Troutman Pepper

The Latest Successful Caremark Claim

Troutman Pepper on

In Teamsters Local 443 Health Services & Insurance Plan v. Chou, the Delaware Court of Chancery held, at the pleading stage, that plaintiff stockholders had stated a claim for Caremark oversight liability against certain of...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

King & Spalding

Court Dismisses Shareholder Suit Seeking To Recover Stock Drop from FDA Nonapproval of Experimental Drug

King & Spalding on

Companies that sell products or services that cannot be marketed without regulatory preclearance, and particularly companies that develop experimental drugs and medical devices, should take note of the recent opinion by Judge...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

Skadden, Arps, Slate, Meagher & Flom LLP

HKEx Reforms Attract High-Profile Technology and Biotech Listings

In the past year, nearly a dozen companies have taken advantage of new rules to list on the Stock Exchange of Hong Kong Limited (HKEx). On April 30, 2018, HKEx introduced a series of reforms to encourage the listing of...more

Hinshaw & Culbertson LLP

The Lawyers' Lawyer Newsletter - Halloween Issue October 2016

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TRICK OR TREAT! The editors of the Halloween edition of the Lawyers' Lawyer Newsletter invite you to enjoy frightening tales of shocking assaults by non-clients on an unsuspecting law firm; a lawyer's nail-biting escape from...more

Morris James LLP

Disregard of Speculative Financial Projections Was Not Bad Faith

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In a stockholder challenge to a sale of the company, a plaintiff may rebut the business judgment rule by pleading facts that support a reasonable inference that at least half of the directors, who approved the sale, were not...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

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

Polsinelli

Compounding Quality Act: Critical Implementation Begins Now For Stakeholders

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On Wednesday, December 4, FDA will publish six key documents in the implementation of the Compounding Quality Act, signed into law by President Obama on Monday, December 2. In addition, FDA has withdrawn its current guidance...more

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