Novartis’ Serelaxin Is Early Victim Of East Coast Snow Storm
This article was originally published in The Pink Sheet Daily
FDA postpones Feb. 13 advisory committee review of heart failure drug due to “unanticipated weather conditions” expected for the Washington, D.C. area, although the cardio-renal panel’s meeting on The Medicines Co.’s cangrelor will proceed as planned Feb. 12.
You may also be interested in...
As The Medicines Co.’s anticlotting drug heads to the Cardiovascular and Renal Drugs Advisory Committee, questions about comparator dosing and timing and the severity of bleeding events will be on the agenda.
Once-daily dosing provides a convenience advantage over the other inhaled corticosteroid/long-acting beta-agonist combination products on the COPD market: GlaxoSmithKline’s own Advair and AstraZeneca’s Symbicort.
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.