Lilly’s Thanksgiving Turkey: Lessons From Another Failed Alzheimer’s Program

There was nothing to be thankful about from Lilly’s disclosure that its potential Alzheimer’s therapy solanezumab failed to demonstrate significant improvement in cognition in a third large Phase III trial. But it does reinforce the wisdom of FDA’s standards for subgroup analysis in failed trials.

formula

Eli Lilly & Co.’s day-before-Thanksgiving disclosure that its EXPEDITION3 trial of the potential Alzheimer’s therapy solanezumab failed to meet its primary endpoint didn’t give anyone reason to feel thankful over the long holiday weekend.

It was particularly bad news for Lilly, of course, whose massive investment in the project all goes for naught. The...

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 Approval Standards

More from Pathways & Standards

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.