Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Standards For Early Alzheimer’s Drugs Adapted, Not Loosened, FDA’s Katz Says

This article was originally published in The Pink Sheet Daily

Executive Summary

A draft guidance for development of drugs to treat early Alzheimer’s disease does not loosen agency standards, FDA’s neurology products chief asserts. Rather, it is an attempt to establish criteria tailored to the population.

You may also be interested in...



Lilly Shifts Course With Alzheimer’s Drug Solanezumab

In another sign of uncertainty for Alzheimer’s disease drug development, Lilly shakes things up with announcement of design changes for Phase III trial for solanezumab.

Alzheimer’s Placebo May Become Disease-Modifying Drug For Affiris

Biotech shifts development plans after Phase II study shows surprising, but promising, results – albeit in the wrong arm of the study.

Eisai’s Bayesian Alzheimer’s Trial Aims For Quick Proof Of Concept With Fewer Subjects, Lower Cost

Eisai should get the first feedback from an adaptive Phase II trial of BAN2401 in Alzheimer’s patients with mild cognitive impairment in six or seven months, offering the first opportunity to adjust parameters testing dose response and the antibody’s disease-modifying potential or to stop the trial early for futility.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075506

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel