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

Reminyl Safety Signal Reported In Two Cognitive Impairment Studies

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA and foreign health authorities are investigating mortality rates from two galantamine studies in the treatment of mild cognitive impairment, Johnson & Johnson says. The studies did not demonstrate Reminyl efficacy in the indication.

You may also be interested in...



J&J's Reminyl Adds Mortality Precaution For Mild Cognitive Impairment

The Precautions section of labeling cites two Reminyl studies in patients with mild cognitive impairment in which the treatment-group mortality rate exceeded that of the placebo arm. J&J issues a "Dear Health Care Professional" letter alerting prescribers to the revised labeling.

J&J's Reminyl Adds Mortality Precaution For Mild Cognitive Impairment

The Precautions section of labeling cites two Reminyl studies in patients with mild cognitive impairment in which the treatment-group mortality rate exceeded that of the placebo arm. J&J issues a "Dear Health Care Professional" letter alerting prescribers to the revised labeling.

AstraZeneca Does Not Expect Crestor Labeling Change Following Fatality

The company says that a fatality potentially caused by rhabdomyolysis appeared in spontaneous adverse event reporting for the cholesterol-lowering drug. AstraZeneca maintains that the evidence concerning the cause of death is more consistent with neuroleptic malignant syndrome.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS060929

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