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

BMS, AstraZeneca’s Onglyza Enters Murky Regulatory Waters

This article was originally published in The Pink Sheet Daily

Executive Summary

Scrutiny of potential cardiovascular risks looms over new diabetes drugs.

You may also be interested in...



Onglyza advisory panel review

Bristol-Myers Squibb/AstraZeneca's DPP-4 inhibitor Onglyza (saxagliptin) will be reviewed by FDA's Endocrinologic and Metabolic Drugs Advisory Committee April 1. The application was filed last summer and an action date is set for April 30 (1"The Pink Sheet" DAILY, July 23, 2008). Novo Nordisk's GLP-1 analog Victoza (liraglutide) already was on the committee calendar for April 2, an event that has been anticipated as the showcase for real-world implementation of new cardiovascular safety guidance governing type 2 diabetes drugs. Unveiled in December, that guidance requires an in-depth safety review for type 2 diabetes medications, including studies of CV mortality, myocardial infarction and stroke (2"The Pink Sheet" DAILY, Dec. 17, 2008)

Onglyza advisory panel review

Bristol-Myers Squibb/AstraZeneca's DPP-4 inhibitor Onglyza (saxagliptin) will be reviewed by FDA's Endocrinologic and Metabolic Drugs Advisory Committee April 1. The application was filed last summer and an action date is set for April 30 (1"The Pink Sheet" DAILY, July 23, 2008). Novo Nordisk's GLP-1 analog Victoza (liraglutide) already was on the committee calendar for April 2, an event that has been anticipated as the showcase for real-world implementation of new cardiovascular safety guidance governing type 2 diabetes drugs. Unveiled in December, that guidance requires an in-depth safety review for type 2 diabetes medications, including studies of CV mortality, myocardial infarction and stroke (2"The Pink Sheet" DAILY, Dec. 17, 2008)

FDA Diabetes Panel Fattens Lineup With April 1 Review Of Onglyza

Bristol-Myers stays mum on cardiovascular events in trials; agency’s demands are soon to become clearer.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS068127

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