In Brief

Shareholder suit against Johnson & Johnson, including CFO Caruso, may proceed; Novartis pauses OTC production at Nebraska plant; Mead Johnson finds Enfamil powder clear of bacteria after stores pull the product; John Gay leaves NPA after two years as executive director and CEO; more news In Brief.

A class action complaint alleging securities fraud at Johnson & Johnson is permitted to proceed against Colleen Goggins, former chairman of the firm’s worldwide consumer group, and current Chief Financial Officer Dominic Caruso – and by virtue of those defendants, against J&J as well – a federal judge says Dec. 19. Judge Freda Wolfson of the U.S. District Court for the District of New Jersey granted J&J’s motion to dismiss with respect to CEO William Weldon and Consumer Healthcare President Peter Luther, noting the plaintiffs had failed to prove allegations that Weldon and Luther misrepresented their awareness of OTC quality control problems and a “phantom recall” of Motrin. Wolfson says it appears “plausible” that Goggins knew of the phantom recall despite telling a congressional committee she did not, and finds Caruso may have made misleading statements during an investor call. As part of a separate suit, a J&J special committee found organizational changes, but not individual executives, at fault for the QC problems that led to extensive OTC recalls Also see "J&J Directors Find Root Causes But Little Blame For OTC Quality Issues" - Pink Sheet, 25 July, 2011..

Novartis Consumer Health temporarily shuts down production of OTC and dietary supplement brands including Excedrin, Theraflu, Triaminic, Maalox, Lamisil and...

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

More from Europe

UK HRA Working On ‘Trusted’ Path Forward To Support Simplified Informed Consent

 
• By 

The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.

EU Ups Ante On Stockpiling For Crises

 

The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

 

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

More from Geography

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

 

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By 

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.