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

DeCODE Heart Attack Drug To Return To Phase III With Expanded Study Population

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

DeCODE Genetics has expanded the patient population for its Phase III trial of its lead compound DG031 to include all patients who carry a variant of one of the genes the company has linked to risk of heart attack via the leukotriene pathway.

You may also be interested in...



Novartis Galvus "approvable"

Novartis will likely have to conduct another clinical trial of its dipeptidyl peptidase-4 inhibitor Galvus (vildagliptin) following a Feb. 23 "approvable" letter. FDA had earlier requested a three-month extension of the initial November 2006 user fee date due to concerns about necrotoxicity seen in preclinical studies. Novartis said FDA remains concerned about the skin toxicity and that some patients may be predisposed to achieving high plasma levels with standard doses. FDA requested that all manufacturers developing DPP-4 agents characterize their compounds' dermatologic safety profiles. Cleared in October, FDA did not see skin toxicity in Merck's Januvia (sitagliptin), which was the first DPP-4 inhibitor to be approved (1Pharmaceutical Approvals Monthly January 2007, p. 29)...

Asia Spotlight: Ascendancy Healthcare CEO Sandy Zweifach On The Gap In China

Seeing a gap between the large infrastructure being built in China by multinational and domestic companies, Ascendancy hopes to be an interface to help China access drugs from the West.

Ascendancy Healthcare CEO Sandy Zweifach On The Gap In China: An Interview With PharmAsia News (Part 2 of 2)

Seeing a gap between the large infrastructure being built in China by multinational and domestic companies, Ascendancy hopes to be an interface to help China access drugs from the West.

Latest Headlines
See All
UsernamePublicRestriction

Register

PS003549

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