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


For Novartis, No Relax’in On Serelaxin: More Trials Likely

This article was originally published in The Pink Sheet Daily

Executive Summary

Novartis released mixed Phase III data on its heart failure candidate at the American Heart Association Scientific Sessions, showing the drug reduced symptoms of acute heart failure but failed to demonstrate an improvement on a second endpoint, cardiovascular death and hospital stays at 60 days.

You may also be interested in...

Stick To Basics: Attempt To Improve Heart Failure Symptomatic Endpoint Trips Up Novartis’ Serelaxin

While on paper a surrogate endpoint was OK with the agency, company’s attempt to advance endpoint by incorporating clinical outcomes gets pushback from FDA and its advisors.

FDA Advisors Think Novartis’ Serelaxin Could Perform Better On More Difficult Endpoints

Advisory committee rejects heart failure treatment but expects drug may show success if evaluated on harder clinical endpoints.

Novartis Likely Stuck Waiting For Second Phase III For Serelaxin Approval

FDA recommends against approval of Novartis’ heart failure drug serelaxin in run up to advisory panel, signaling company may need second Phase III study just beginning to get drug okayed.

Related Content


Related Companies

Latest Headlines
See All



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