We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » DISCOVERY LABS FACES LAWSUITS BASED ON SURFAXIN FAILURE

DISCOVERY LABS FACES LAWSUITS BASED ON SURFAXIN FAILURE

May 3, 2006

Two Pennsylvania law firms have filed class action lawsuits against Discovery Labs for allegedly misleading stockholders on Surfaxin's prospects for federal approval.

The suits, filed by the law offices of Bernard M. Gross and the firm Goldman, Scarlato & Karon on behalf of purchasers of Discovery's common stock, allege the company violated several provisions of the Securities and Exchange Act of 1934. The Gross lawsuit claims the company issued "a series of materially false and misleading statements" regarding Surfaxin's progress through the FDA and "repeatedly represented that they anticipated FDA approval of Surfaxin in April 2006".

Last week, Discovery announced that test batches of the drug showed stability problems, causing significant delays in the FDA approval process. The Gross lawsuit states that that in that announcement, "the company admitted that although it had been testing the 'production validation batches' periodically for 'stability,' stability had never been achieved."

Noting that the company's stock price dropped 53 percent on the news of Surfaxin's setback, Gross said the lawsuit seeks to recover damages suffered by stockholders.

Also, another firm, Schatz & Nobel, has filed a suit seeking class action status on behalf of Discovery stockholders for the same allegations. All three filings are in the U.S. District Court for the Eastern District of Pennsylvania.

KEYWORDS Daily International Pharma Alert

Upcoming Events

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 13Sep

    Trial Master File Inspection Readiness: From Chaos to Calm

  • 14Sep

    Omnichannel Engagement: Are You Digitally Ready?

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 21Sep

    The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Guardant Health Receives FDA Approval for Guardant360 CDx Liquid Biopsy Test

  • Genentech Inks Licensing Deal With Jemincare Over Androgen Receptor Degrader

  • FDA Clears Thermo Fisher Scientific’s Wheat and Sesame Allergy Tests

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing