The so-called 21st Century Cures Act, now making its way through Congress, is designed to speed up the FDA review process for potentially lifesaving medicines by encouraging approvals based on midstage data. But a new case study takes a look at what might have happened if a trio of once-promising Alzheimer's drugs had made it to market before their eventual Phase III failures, painting a grim picture of the bill's potential.
Investigators will test the drug in a region of Colombia where a particular genetic mutation is known to trigger the early onset of Alzheimer's.
Here's an interesting number for anyone interested in the risks and rewards of drug development: Two of every three analysts and fund managers recently queried by the ISI Group say they expect that new Alzheimer's drugs in late-stage testing at Eli Lilly and Pfizer/J&J will fail.
One of the most popular sessions at the Alzheimer's Association International Conference in Paris this week was directed by Eli Lilly's Eric Siemers, who offered a detailed look at the experiences of