1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

In Brief

J&J agrees to settle shareholder complaint; USPlabs destroys DMAA product; Acura strengthens Nexafed; Abbott nutrition sales drive growth; Re-launches drive Novartis OTC rebound; more news In Brief.

Johnson & Johnson agrees to pay $22.9 million to settle a class-action complaint alleging it misled investors about manufacturing quality-control problems that caused widespread recalls of Tylenol products and other leading OTCs marketed by subsidiary McNeil Consumer Healthcare and led to a consent decree with FDA covering three facilities. According to the proposed settlement filed July 15 in U.S. District Court for New Jersey in Trenton, J&J admits no wrongdoing concerning the claim that the plaintiffs suffered stock losses because J&J executives made misleading statements about the recalls. If approved, the settlement would cover buyers of shares between Oct. 14, 2008, and July 21, 2010. The firm in July 2012 resolved a similar shareholder complaint by agreeing to implement company-wide quality control oversight measures. The firm began returning the recalled products to stores shelves in 2012, and says in its latest earnings statement that its U.S. OTC sales are turning around ([A#05130722007]).

The fight finally goes out of USPlabs LLC, which voluntarily destroyed $8 million worth of DMAA-containing products July 2, FDA...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

BIO Notebook: Policy Uncertainty Constraining Dealmaking

 
• By Mandy Jackson and Joseph Haas

Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
• By Sarah Karlin-Smith

The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

US FDA’s Top Cell and Gene Therapy Regulators Forced Out

 
• By Sarah Karlin-Smith

Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.

More from North America

First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 
• By Bridget Silverman

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.