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Guidance For Drugs To Target Early Alzheimer’s Notes Lack Of Metrics, Biomarkers

 
• By Shirley Haley

FDA’s new draft guidance on developing drugs to treat people in the early stages of Alzheimer’s disease, before any noticeable dementia sets in, is sure to generate further discussion and comment on how best to identify and measure the disease and its progression.

FDA’s new draft guidance on developing drugs for presymptomatic Alzheimer’s patients – the target population that researchers, drug makers and regulators agree is the best chance for affecting the course of the disease – reflects the general lack of tools available to measure or even identify progress.

Under a section on diagnostic criteria, the agency offers little advice on picking patients for a trial, instead stating that...

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• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.